Trial from ClinicalTrials.gov

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Trial ID
NCT02516592
Ethics application status
Date submitted
4/08/2015
Date registered
4/08/2015
Date last updated
20/09/2016

Titles & IDs
Public title
Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort
Scientific title
A 12-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Switching From Salmeterol/Fluticasone to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic COPD Patients
Secondary ID [1] 0 0
CQVA149A3405
Universal Trial Number (UTN)
Trial acronym
FLASH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: drugs - QVA149 110/50 micrograms
Treatment: drugs - Salmeterol/fluticasone 50/500 microgrammes

Experimental: QVA149 110/50 micrograms - QVA149 110/50 micrograms o.d. Capsules for inhalation

Active Comparator: salmeterol/fluticasone 50/500 micrograms - salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder


Treatment: drugs: QVA149 110/50 micrograms
QVA149 110/50 micrograms o.d. capsules for inhalation, supplied in blisters via a single dose dry powder inhalater (SDDPI)

Treatment: drugs: Salmeterol/fluticasone 50/500 microgrammes
Salmeterol/fluticasone 50/500 microgrammes b.i.d.dry inhalation powder delivered via Accuhaler / Diskus device

Intervention code [1] 0 0
Treatment: drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in trough pre-dose FEV1 in both arms - Pulmonary function assessments were performed using centralized spirometry according to international standards. Mean trough pre-dose FEV1 at Week 12 is defined as the average of the measurements taken -45min and -15min pre study medication dose in the clinic after 12 weeks of treatment (Day 84). The baseline measurement is defined as the average of the scheduled FEV1 values prior to first intake of randomized study drug at Day 1 (Visit 2).
Timepoint [1] 0 0
week 12
Secondary outcome [1] 0 0
Transitional Dyspnea Index (TDI) focal score - The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of =1 was defined as a clinically important improvement from baseline.
Timepoint [1] 0 0
week 12
Secondary outcome [2] 0 0
Change from baseline in FVC (Forced Vital Capacity) - Pulmonary function assessments were performed using centralized spirometry according to international standards. FVC wil follow the same analysis as for FEV1
Timepoint [2] 0 0
week 12
Secondary outcome [3] 0 0
Change from baseline in total symptom score- CAT (COPD Assessment Test) - The participants will record their COPD symptoms in this test before every clinic visit, this will include : cough, phlegm, chest tightness, breathlessness, limitation in activities, energy, soundly sleep, etc. A higher score indicates a worse health status. The result is immediately available without the need for any calculation, apart from summing the scores on individual items. Scores of 0 - 10, 11 - 20, 21 - 30 and 31 - 40 represent a mild, moderate, severe or very severe clinical impact of COPD upon the patient.
Timepoint [3] 0 0
week 12
Secondary outcome [4] 0 0
Change from baseline in mean daily use of rescue medication - Use of rescue medication (number of puffs taken in the previous 12 hours) is recorded morning and evening, by the patient, in a paper diary. A negative change from baseline indicates an improvement.
Timepoint [4] 0 0
over 12 weeks

Eligibility
Key inclusion criteria
- Written informed consent must be obtained before any assessment is performed.

- Male and female = 40 years

- Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack
years are defined as 20 cigarettes per day for 10 years or 10 cigarettes per day for
20 years). An ex-smoker is defined as a patient who has not smoked for = 6 months at
visit 1

- Confirmed diagnosis of COPD and post-bronchodilator FEV1 = 30% and < 80% of the
predicted normal value and post-bronchodilator FEV1/FVC < 0.70 at visit 1

- Treated with salmeterol/fluticasone 50/500 µg b.i.d. for at least 3 months prior to
visit 1

- Documented CAT score of = 10 at Visit 1 and 2
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Treatment with any LAMA in the 2 weeks prior to visit 1

- Presence of any contraindication, warning, precaution, hypersensitivity in the
approved prescribing information for salmeterol/fluticasone

- Prior or current diagnosis of asthma

- More than one COPD exacerbation requiring treatment with antibiotics and/or systemic
corticosteroids and/or hospitalization in the year prior to Visit 1

- Patients who developed a COPD exacerbation of any severity within the 6 weeks before
the screening (Visit 1) or between screening (Visit 1) and start of treatment (Visit
2) will not be eligible but will be permitted to be re-screened after a minimum of 6
weeks after the resolution of the COPD exacerbation

- Respiratory tract infection within 4 weeks prior to Visit 1

- Respiratory tract infection between Visit 1 and 2. Patients can be re-screened 4 weeks
after resolution of the infection

- Requiring oxygen therapy prescribed for >12 hours per day

- Onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Drummoyne
Recruitment hospital [2] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [3] 0 0
Novartis Investigative Site - Cairns
Recruitment hospital [4] 0 0
Novartis Investigative Site - Glen Osmond
Recruitment hospital [5] 0 0
Novartis Investigative Site - Murdoch
Recruitment hospital [6] 0 0
Novartis Investigative Site - Bedford Park
Recruitment hospital [7] 0 0
Novartis Investigative Site - Daw Park
Recruitment postcode(s) [1] 0 0
2047 - Drummoyne
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4870 - Cairns
Recruitment postcode(s) [4] 0 0
5064 - Glen Osmond
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment postcode(s) [6] 0 0
SA 5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
5041 - Daw Park
Recruitment outside Australia
Country [1] 0 0
Egypt
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Alexandria
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Egypt
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Cairo
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Egypt
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Fayoum
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India
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Andhra Pradesh
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India
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Gujarat
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India
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Maharashtra
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India
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Tamil Nadu
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Israel
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Ashkelon
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Israel
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Be'er Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petach Tikva
Country [13] 0 0
Israel
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Rehovot
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Israel
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Sefad
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Israel
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Tel Giborim, Holon
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Lebanon
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LBN
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Lebanon
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Beirut
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Lebanon
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Hazmieh
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Lebanon
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Saida
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Malaysia
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Kelantan
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Malaysia
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Pahang
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Malaysia
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Perak
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Malaysia
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Sarawak
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Malaysia
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Kuala Lumpur
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Philippines
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Batangas
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Philippines
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Bulacan
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Philippines
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Manila
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Philippines
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Quezon City
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Philippines
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San Pablo City, Laguna
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Saudi Arabia
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SAU
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Saudi Arabia
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Al Khobar
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Saudi Arabia
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Jeddah
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Gatesville
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South Africa
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Johannesburg
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South Africa
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Phoenix
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Taiwan
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Chia-Yi
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Taiwan
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Kaoshiung
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Taiwan
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Lin-Kou
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Taiwan
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Taichung
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Taiwan
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Taipei County
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Aydin
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Turkey
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Erzurum
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Konya
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Turkey
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Mersin
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Turkey
State/province [51] 0 0
Trabzon
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Turkey
State/province [52] 0 0
Yenisehir/Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will investigate whether switching symptomatic COPD patients from a fixed-dose
combination of salmeterol/fluticasone 50/500 µg b.i.d. to a fixed dose combination of QVA149
110/50 µg o.d. leads to improved lung function and airflow. It will also assess the effect on
symptom burden, breathlessness, and use of rescue medication after this switch.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
+41613241111
Fax 0 0
Email 0 0
Contact person for scientific queries
Contact person responsible for updating information