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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03345407




Registration number
NCT03345407
Ethics application status
Date submitted
14/11/2017
Date registered
17/11/2017

Titles & IDs
Public title
Dose Finding Study of Nemiralisib (GSK2269557) in Subjects With an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
A Phase IIb, Randomized (Stratified), Double-Blind (Sponsor Open), Parallel-Group, Placebo-Controlled, Dose-Finding Study of Nemiralisib (GSK2269557) Added to Standard of Care (SoC) Versus SoC Alone in Participants Diagnosed With an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 0 0
2017-001074-42
Secondary ID [2] 0 0
200879
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo ELLIPTA
Treatment: Drugs - Nemiralisib ELLIPTA 50 µg
Treatment: Drugs - Nemiralisib ELLIPTA 100 µg
Treatment: Drugs - Nemiralisib ELLIPTA 250 µg
Treatment: Drugs - Nemiralisib ELLIPTA 500 µg
Treatment: Drugs - Nemiralisib ELLIPTA 750 µg
Treatment: Drugs - Albuterol (Salbutamol) MDI or nebules
Treatment: Drugs - Standard of care therapy

Placebo comparator: placebo once daily - Eligible subjects will receive placebo ELLIPTA dry powder (blended with lactose) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.

Experimental: Nemiralisib 50 µg once daily - Eligible subjects will receive nemiralisib ELLIPTA 50 µg dry powder (blended with lactose and magnesium stearate) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.

Experimental: Nemiralisib 100 µg once daily - Eligible subjects will receive nemiralisib ELLIPTA 100 µg dry powder (blended with lactose and magnesium stearate) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.

Experimental: Nemiralisib 250 µg once daily - Eligible subjects will receive nemiralisib ELLIPTA 250 µg dry powder (blended with lactose and magnesium stearate) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.

Experimental: Nemiralisib 500 µg once daily - Eligible subjects will receive nemiralisib ELLIPTA 500 µg dry powder (blended with lactose and magnesium stearate) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.

Experimental: Nemiralisib 750 µg once daily - Eligible subjects will receive nemiralisib ELLIPTA 750 µg dry powder (blended with lactose and magnesium stearate) for oral inhalation once daily in the morning for 12 weeks. Albuterol (Salbutamol) MDI or nebules will also be provided to all subjects for use as rescue medication as needed.


Treatment: Drugs: Placebo ELLIPTA
Placebo will be administered via oral inhalation route once daily in the morning.

Treatment: Drugs: Nemiralisib ELLIPTA 50 µg
Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 50 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.

Treatment: Drugs: Nemiralisib ELLIPTA 100 µg
Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 100 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.

Treatment: Drugs: Nemiralisib ELLIPTA 250 µg
Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 250 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.

Treatment: Drugs: Nemiralisib ELLIPTA 500 µg
Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 500 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.

Treatment: Drugs: Nemiralisib ELLIPTA 750 µg
Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 750 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.

Treatment: Drugs: Albuterol (Salbutamol) MDI or nebules
Albuterol (Salbutamol) MDI or nebules will be provided to all subjects as a rescue medication.

Treatment: Drugs: Standard of care therapy
SoC therapy for the index exacerbation is defined as treatment with oral/systemic corticosteroid (prednisone 40 mg/day or equivalent) for 5 days and antibiotic for 7 days. Subjects will receive SoC as prescribed by the Investigator or medically qualified designee. The dose and/or duration of prednisone and/or the antibiotic can be modified according to the Investigator's/medically qualified designee's judgment or according to local country/institution practice.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 84 Measured Post Bronchodilator
Timepoint [1] 0 0
Baseline and Day 84
Secondary outcome [1] 0 0
Rate of Moderate and Severe Exacerbations Over 12-week Treatment Period
Timepoint [1] 0 0
Up to Week 12
Secondary outcome [2] 0 0
Number of Participants With Time to Next Moderate/Severe Exacerbation Following Index Exacerbation
Timepoint [2] 0 0
Up to Week 12
Secondary outcome [3] 0 0
Change From Baseline in Clinic Visit Trough FEV1 Measured Pre and Post-bronchodilator
Timepoint [3] 0 0
Baseline and Days 14, 28, 56 (pre and post bronchodilaor), 84 (pre-bronchodilator) and at hospital discharge (maximum 24 Weeks)
Secondary outcome [4] 0 0
Change From Hospital Discharge in Clinic Visit Trough FEV1 Measured Pre and Post-bronchodilator
Timepoint [4] 0 0
Baseline and pre- and post-bronchodilator on Days 14, 28, 56 and 84
Secondary outcome [5] 0 0
Percentage of Participants Achieving the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Definition of Recovery From the Index Exacerbation
Timepoint [5] 0 0
Days 14, 28, 56 and 84
Secondary outcome [6] 0 0
Number of Participants With Time to Recovery From Index Exacerbation Using EXACT- PRO Tool
Timepoint [6] 0 0
From randomization to Week 12
Secondary outcome [7] 0 0
Mean Severity of Subsequent Health Care Resource Use (HCRU) Exacerbations Defined by EXACT
Timepoint [7] 0 0
Up to Week 12
Secondary outcome [8] 0 0
Percentage of Responders Using the COPD Assessment Test (CAT) on Treatment Days 28, 56, and 84, and Following EXACT Defined Recovery From the Index Exacerbation
Timepoint [8] 0 0
Days 28, 56 and 84
Secondary outcome [9] 0 0
Change From Baseline in CAT Total Score
Timepoint [9] 0 0
Baseline and at Days 28, 56 and 84
Secondary outcome [10] 0 0
Percentage of Responders on the St. George's Respiratory Questionnaire (SGRQ) Total Score as Measured by the SGRQ for COPD Participants (SGRQ-C) at Days 28, 56, and 84
Timepoint [10] 0 0
Days 28, 56 and 84
Secondary outcome [11] 0 0
Change From Baseline in SGRQ Total Score at Days 28, 56 and 84
Timepoint [11] 0 0
Baseline and Days 28, 56 and 84
Secondary outcome [12] 0 0
Mean Number of Occasions of Rescue Medication Use Per Day
Timepoint [12] 0 0
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 of treatment and over the Week 12 treatment period
Secondary outcome [13] 0 0
Percentage of Rescue-free Days
Timepoint [13] 0 0
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 of treatment and over the Week 12 treatment period
Secondary outcome [14] 0 0
Plasma Concentration of Nemiralisib
Timepoint [14] 0 0
Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28
Secondary outcome [15] 0 0
Number of Participants Reporting Non-serious Adverse Events (Non-SAEs), SAEs and AE of Special Interest (AESI)
Timepoint [15] 0 0
Up to Week 24
Secondary outcome [16] 0 0
Number of Participants With Worst Case Post Baseline Diastolic Blood Pressure (DBP), Systolic Blood Pressure (SBP) and Pulse Rate
Timepoint [16] 0 0
Up to Week 16
Secondary outcome [17] 0 0
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Timepoint [17] 0 0
Screening, Days 14, 84, 112 and at early withdrawal
Secondary outcome [18] 0 0
Number of Participants With Worst Case Post Baseline Clinical Chemistry Values
Timepoint [18] 0 0
Upto Week 16
Secondary outcome [19] 0 0
Number of Participants With Worst Case Post Baseline Hematology Values
Timepoint [19] 0 0
Upto Week 16
Secondary outcome [20] 0 0
Number of Participants Reporting COPD Exacerbations
Timepoint [20] 0 0
Up to Week 16

Eligibility
Key inclusion criteria
* 40 to 80 years of age, inclusive, at Screening (Visit 1).
* An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [ global initiative for chronic obstructive lung disease (GOLD), 2017] as follows: "Chronic obstructive pulmonary disease is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases."
* Current or former cigarette smoker with a history of cigarette smoking of >=10 pack-years. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Screening (Visit 1). Number of pack years = (number of cigarettes per day / 20) x number of years smoked).
* Acute exacerbation of COPD requiring an escalation in therapy to include oral/systemic corticosteroid(s) (prednisone 40 mg/day or equivalent) for 5 days and antibiotic(s) for 7 days; the dose and/or duration of prednisone (40 mg/day or equivalent) and/or the antibiotic can be modified according to the Investigator's/medically qualified designee's judgment or according to local country/institution practice. Acute exacerbation to be confirmed by an experienced physician and to represent a recent worsening of at least two major and one minor symptoms, one major and two minor symptoms, or all 3 major symptoms. Major symptoms include subjective increase in dyspnea, increase in sputum volume or change in sputum color. Minor symptoms include increased cough, increased wheeze, sore throat, colds or fever (oral temperature >37.5 degree Celsius) without other cause.
* Body weight >=45 kilogram (kg) and body mass index (BMI) within the range 16 - 35 kg per meter square (kg/m^2) (inclusive)
* Male and female subjects are eligible to participate in the study. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the 12-Week Double-Blind Treatment Period and for at least 5 half-lives (10 days) after the last of double-blind study treatment.
* Capable of giving signed informed consent.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current diagnosis of asthma, according to the Global Initiative for Asthma (GINA, 2017). Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
* Potential of hydrogen (pH) < 7.30 or the need for invasive mechanical ventilation.
* Moderate/severe exacerbation of COPD for which SoC was started >48 hours since diagnosis.
* A chest X-ray [or computed tomography (CT) scan] that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray (or CT scan) must be taken at Screening (Visit 1). For sites in Germany: if a chest X-ray (or CT scan) within 1 year of Screening (Visit 1) is not available, approval to conduct a diagnostic chest X-ray (CT scan) will need to be obtained from the Federal Office for Radiation Protection (BfS).
* Clinically significant pneumonia, identified by chest X-ray (CT scan) at Screening.
* A diagnosis of alpha 1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, clinically overt bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), primary pulmonary hypertension, interstitial lung diseases,or any other respiratory condition that might, in the opinion of the investigator, compromise the safety of the subject or affect the interpretation of the results.
* A history or current evidence of clinically significant and unstable disease such as cardiovascular (e.g., subjects requiring implanted cardioverter defibrillator [ICD], pacemaker requiring a rate set >60 beats per minute (bpm), uncontrolled hypertension, New Your Heart Association Class IV [NYHA, 1994], known left ventricular ejection fraction <30 percent) neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or hematological abnormalities. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. (Note: subjects with adequately treated and well controlled concurrent medical conditions (e.g. hypertension or noninsulin-dependent diabetes mellitus [NIDDM]) are permitted to be entered into the study).
* Having undergone lung volume reduction surgery or lung resection for any other reason e.g. lung carcinoma
* Liver diseases including ALT>2x upper limit of normal (ULN); Total bilirubin >1.5xULN (Isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent); current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones); Presence of hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to first dose of study treatment; Positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of study treatment.
* Positive hepatitis C ribonucleic acid (RNA) test result at Screening or within 3 months prior to first dose of study treatment.
* Carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin are not excluded if the subject has been considered cured within 5 years since diagnosis.
* History of allergy or hypersensitivity to any of the study medications [e.g. beta-agonists, Phosphoinositide 3-Kinase Delta (PI3Kd) inhibitors] or components of the inhalation powder (e.g., lactose). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the investigator, contraindicates the subject's participation are excluded.
* Strong inhibitors of cytochrome P450 3A4 (CYP3A4) including antiretrovirals including protease inhibitors; Oral antifungal treatments such as ketoconazole and itraconazole. It is recommended that posaconazole is used as the oral antifungal treatment of choice. Short courses of up to 14 days are allowed for fluconazole and voriconazole, but chronic administrations are not permitted; Antibiotics such as telithromycin and troleandomycin (macrolide). It is recommended that azithromycin is used as the macrolide antibiotic of choice. Short courses up to 14 days are allowed for mibefradil (calcium channel blocker), erythromycin and clarithromycin (including intravenous clarithromycin) but chronic administrations are not permitted; Anti-epileptic treatments; and anti-tuberculosis therapy. These medications must all have been stopped at least 14 days prior to first dose of study treatment. Use of sensitive narrow therapeutic index CYP3A4 substrates including alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus; Intravenous theophylline will be allowed but only under strict therapeutic drug monitoring for signs of theophylline toxicity as a result of co-administration with nemiralisib; Subjects may be recruited into the study already under treatment with theophylline or started on theophylline following the start of treatment and before the end of 14 days post last dose.
* Chronic treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for >15 hours a day. Oxygen prn use (<=15 hours per day) is not exclusionary. Oxygen use during an exacerbation is permitted.
* Chronic treatment with anti-Tumor Necrosis Factor (anti-TNF), anti-Interleukin-1 (anti-IL1), or any other immunosuppressive therapy within 60 days prior to the first dose of double-blind study treatment.
* Clinically significant sleep apnea that requires the use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) for > 48 hours.
* Any other investigational treatment within the following time periods prior to the first dose of double-blind study treatment in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product, whichever is longer. Note: subjects who participated in a previously completed study and/or were withdrawn from an ongoing study that included/includes nemiralisib are excluded from participating in this study.
* Exposure to more than 4 investigational medicinal products within 12 months prior to the first dose of double-blind study treatment in the current study.
* A clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the exclusion criteria, outside of the reference range for the population being studied may be included if the Investigator [in consultation with the GlaxoSmithKline (GSK) Medical Monitor if required] documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Abnormal, clinically significant ECG finding (e.g. myocardial Infarction or demonstrating a clinically significant arrhythmia requiring treatment) at Screening (Visit 1) or upon repeat prior to randomization.
* QT interval corrected for heart rate according to Fridericia's formula (QTcF) >480 milliseconds (msec) for subjects with or without Bundle Branch Block, based on single QTcF value.
* A positive test for human immunodeficiency virus (HIV) antibody at Screening.
* Known or suspected history of alcohol or drug abuse within the last 2 years.
* History of regular alcohol consumption defined as an average weekly intake of >28 units for males or >21 units for females within 6 months of Screening (Visit 1). One unit is equivalent to 8 grams of alcohol: a half-pint [approximately 240 milliliter (mL)] of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
* Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
* Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
* Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/01/2019
Sample size
Target
Accrual to date
Final
943
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Gosford
Recruitment hospital [2] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [3] 0 0
GSK Investigational Site - Woolloongabba
Recruitment hospital [4] 0 0
GSK Investigational Site - Woodville South
Recruitment hospital [5] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [6] 0 0
GSK Investigational Site - Murdoch
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
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Florida
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United States of America
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Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
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Missouri
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United States of America
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Nebraska
Country [8] 0 0
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North Carolina
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Ohio
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United States of America
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Pennsylvania
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South Carolina
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United States of America
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South Dakota
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United States of America
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Virginia
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United States of America
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West Virginia
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Argentina
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Buenos Aires
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Argentina
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Mendoza
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Argentina
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Santa Fe
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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Tucuman
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Canada
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Alberta
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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France
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Brest cedex
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France
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Lyon
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France
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Montpellier cedex 5
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France
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Rennes Cedex 9
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France
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Vandoeuvre-lès-Nancy cedex
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Germany
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Bayern
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Germany
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Brandenburg
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Sicilia
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Italy
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Veneto
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Korea, Republic of
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Daejon
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Korea, Republic of
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Incheon
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Korea, Republic of
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Jeonju-si, Jeollabuk-do
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Korea, Republic of
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Seongnam-si, Gyeonggi-do
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Korea, Republic of
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Seoul
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Mexico
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Jalisco
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Mexico
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Nuevo León
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Netherlands
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Alkmaar
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Breda
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Eindhoven
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Groningen
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Harderwijk
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Hoorn
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Rotterdam
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Utrecht
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Netherlands
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Zwolle
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Poland
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Bialystok
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Poland
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Elblag
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Poland
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Krakow
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Poland
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Lubin
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Poland
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Olawa
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Poland
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Ruda Slaska
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Poland
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Slupsk
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Poland
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Sosnowiec
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Poland
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Tarnow
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Romania
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Bucarest
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Romania
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Bucharest
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Romania
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Cluj Napoca
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Romania
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Comuna Alexandru Cel Bun
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Romania
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Iasi
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Romania
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Oradea
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Romania
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Ramnicu Valcea
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Romania
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Suceava
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Romania
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Timisoara
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Russian Federation
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Barnaul
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Russian Federation
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Belgorod
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Russian Federation
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Blagoveshchensk
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Chelyabinsk
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Ivanovo
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Kemerovo
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Nizhniy Novgorod
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Novgorod
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Novosibirsk
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Perm
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Ryazan
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Saratov
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Tomsk
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Ulyanovsk
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Voronezh
Country [93] 0 0
Spain
State/province [93] 0 0
Cantabria
Country [94] 0 0
Spain
State/province [94] 0 0
Barcelona
Country [95] 0 0
Spain
State/province [95] 0 0
Basurto/Bilbao
Country [96] 0 0
Spain
State/province [96] 0 0
Cartagena (Murcia)
Country [97] 0 0
Spain
State/province [97] 0 0
Cáceres
Country [98] 0 0
Spain
State/province [98] 0 0
Elda (Alicante)
Country [99] 0 0
Spain
State/province [99] 0 0
Gerona
Country [100] 0 0
Spain
State/province [100] 0 0
Logroño
Country [101] 0 0
Spain
State/province [101] 0 0
Madrid
Country [102] 0 0
Spain
State/province [102] 0 0
Mérida (Badajoz)
Country [103] 0 0
Spain
State/province [103] 0 0
Orihuela (Alicante)
Country [104] 0 0
Spain
State/province [104] 0 0
Palma de Mallorca
Country [105] 0 0
Spain
State/province [105] 0 0
Pama de Mallorca
Country [106] 0 0
Spain
State/province [106] 0 0
Ponferrada (León)
Country [107] 0 0
Spain
State/province [107] 0 0
Pozuelo De Alarcón/Madrid
Country [108] 0 0
Sweden
State/province [108] 0 0
Göteborg
Country [109] 0 0
Sweden
State/province [109] 0 0
Lund
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Derbyshire
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Lanarkshire
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Blackburn
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Bradford
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Edgbaston
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Edinburgh
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Liverpool
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Sheffield
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Stockton-on-Tees

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study is available via the Clinical Study Data Request site

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com/Posting.aspx?ID=20850


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03345407