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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01202188




Registration number
NCT01202188
Ethics application status
Date submitted
13/09/2010
Date registered
15/09/2010
Date last updated
9/09/2013

Titles & IDs
Public title
A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
A 26-week Treatment Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled (Open Label) Study to Assess the Efficacy, Safety and Tolerability of QVA149 (110/50 µg q.d.) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 0 0
2009-017772-25
Secondary ID [2] 0 0
CQVA149A2303
Universal Trial Number (UTN)
Trial acronym
SHINE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 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 - indacaterol and glycopyrronium (QVA149)
Treatment: Drugs - glycopyrronium (NVA237)
Treatment: Drugs - indacaterol (QAB149)
Treatment: Drugs - tiotropium
Treatment: Drugs - placebo

Experimental: indacaterol and glycopyrronium (QVA149) - QVA149 110/50 µg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

Active comparator: glycopyrronium (NVA237) - NVA237 50 µg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

Active comparator: indacaterol (QAB149) - QAB149 150 µg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

Active comparator: tiotropium - Tiotropium 18 µg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

Placebo comparator: Placebo - Matching placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.


Treatment: Drugs: indacaterol and glycopyrronium (QVA149)
Capsules for inhalation delivered via SDDPI.

Treatment: Drugs: glycopyrronium (NVA237)
Capsules for inhalation delivered via SDDPI.

Treatment: Drugs: indacaterol (QAB149)
Capsules for inhalation delivered via SDDPI.

Treatment: Drugs: tiotropium
Capsules for inhalation delivered via HandiHaler® device.

Treatment: Drugs: placebo
Placebo to match capsules for inhalation delivered via SDDPI.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment
Timepoint [1] 0 0
23 hours 15 minutes and 23 hour 45 minute post-dose Week 26
Secondary outcome [1] 0 0
Transitional Dyspnea Index (TDI) Focal Score at Week 26
Timepoint [1] 0 0
Week 26
Secondary outcome [2] 0 0
St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 26
Timepoint [2] 0 0
26 weeks
Secondary outcome [3] 0 0
Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Over 26 Weeks
Timepoint [3] 0 0
Baseline, Week 26
Secondary outcome [4] 0 0
Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149, QAB149 and NVA237 Compared to Placebo
Timepoint [4] 0 0
23 hours 15 minutes and 23 hour 45 minute post-dose Week 26
Secondary outcome [5] 0 0
Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149 Compared to Tiotropium
Timepoint [5] 0 0
23 hours 15 minutes and 23 hour 45 minute post-dose Week 26
Secondary outcome [6] 0 0
Baseline Transitional Dyspnea Index (BDI/TDI) Focal Score at Week 12 and Week 26
Timepoint [6] 0 0
Baseline, Week 12, Week 26
Secondary outcome [7] 0 0
Percentage of Patients With a Clinically Important Improvement of at Least 1 Point in TDI Focal Score After 26 Weeks of Treatment
Timepoint [7] 0 0
Baseline, Week 26
Secondary outcome [8] 0 0
St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 and 26 Weeks of Treatment
Timepoint [8] 0 0
Week 12, Week 26
Secondary outcome [9] 0 0
Percentage of Patients With a Clinically Important Improvement From Baseline of at Least 4 Units in the SGRQ Total Score After 26 Weeks of Treatment
Timepoint [9] 0 0
Baseline, Week 26
Secondary outcome [10] 0 0
Percentage of Nights With "No Night Time Awakenings" Over 26 Weeks
Timepoint [10] 0 0
26 Weeks
Secondary outcome [11] 0 0
Percentage of Days With "No Daytime Symptoms" Over 26 Weeks
Timepoint [11] 0 0
26 Weeks
Secondary outcome [12] 0 0
Percentage of "Days Able to Perform Usual Daily Activities" Over 26 Weeks
Timepoint [12] 0 0
26 Weeks
Secondary outcome [13] 0 0
Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication at Week 12 and Week 26
Timepoint [13] 0 0
Baseline, Week 12, Week 26
Secondary outcome [14] 0 0
Change From Baseline (BL) in the Daytime and Night Time Rescue Medication Use (Number of Puffs) Over 26 Weeks
Timepoint [14] 0 0
Baseline, Week 26
Secondary outcome [15] 0 0
Percentage of "Days With no Rescue Medication Use" Over 26 Weeks
Timepoint [15] 0 0
26 Weeks
Secondary outcome [16] 0 0
Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours at Day 1 and Week 26
Timepoint [16] 0 0
From 5 minutes to 4 hours post-dose Day 1 and Week 26
Secondary outcome [17] 0 0
Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours at Day 1 and Week 26
Timepoint [17] 0 0
From 5 minutes to 12 hours post-dose Day 1 and Week 26
Secondary outcome [18] 0 0
Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes at Week 26
Timepoint [18] 0 0
From 5 minutes to 23 hours 45 minutes post-dose Week 26
Secondary outcome [19] 0 0
24 Hour Holter Monitoring in a Subset of Patients
Timepoint [19] 0 0
Week 12, Week 26
Secondary outcome [20] 0 0
Rate of Moderate or Severe COPD Exacerbation
Timepoint [20] 0 0
26 Weeks
Secondary outcome [21] 0 0
Percentage of Patients With at Least One Moderate or Severe COPD Exacerbation Over the 26 Week Treatment Period
Timepoint [21] 0 0
26 Weeks
Secondary outcome [22] 0 0
Percentage of Participants With COPD Exacerbations Requiring Hospitalization or Treatment With Systemic Corticosteroids and/or Antibiotics But no Hospitalization
Timepoint [22] 0 0
26 Weeks

Eligibility
Key inclusion criteria
* Male or female adults aged =40 yrs
* Smoking history of at least 10 pack years
* Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
* Post-bronchodilator FEV1 < 80% and = 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular co-morbid conditions
* Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
* Patients in the active phase of a supervised pulmonary rehabilitation program
* Patients contraindicated for inhaled anticholinergic agents and ß2 agonists
* Other protocol-defined inclusion/exclusion criteria may apply

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
Accrual to date
Final
2144
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Daw Park
Recruitment hospital [2] 0 0
Novartis Investigative Site - Glebe
Recruitment hospital [3] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [4] 0 0
Novartis Investigative Site - Nedlands
Recruitment hospital [5] 0 0
Novartis Investigative site - New lambton
Recruitment postcode(s) [1] 0 0
- Daw Park
Recruitment postcode(s) [2] 0 0
- Glebe
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment postcode(s) [5] 0 0
- New lambton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
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Ohio
Country [9] 0 0
United States of America
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Oregon
Country [10] 0 0
United States of America
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South Carolina
Country [11] 0 0
United States of America
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Tennessee
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Pleven
Country [13] 0 0
Bulgaria
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Russe
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Bulgaria
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Sofia
Country [15] 0 0
Bulgaria
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Stara Zagora
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Varna
Country [17] 0 0
Canada
State/province [17] 0 0
British Columbia
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
France
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Beuvry
Country [21] 0 0
France
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Bourges
Country [22] 0 0
France
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Ferolles-Attily
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France
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Rennes
Country [24] 0 0
Germany
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Berlin
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Germany
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Erfurt
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Germany
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Geesthacht
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Germany
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Hanover
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Germany
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Leipzig
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Germany
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Minden
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Germany
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Witten
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Guatemala
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Guatemala City
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Hungary
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Balassagyarmat
Country [33] 0 0
Hungary
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Budapest
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Hungary
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Gyor
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Hungary
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Komarom
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Hungary
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Nyiregyhaza
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Hungary
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Tatabanya
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Japan
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Asahikawa
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Japan
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Chiba
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Chuo-ku
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Fukuoka
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Hachioji
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Hamakita
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Hiroshima
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Hitachi
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Itabashi
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Iwata
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Kamogawa
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Kishiwada
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Kiyose
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Kurashiki
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Matsusaka
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Matumoto
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Minato-ku
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Moriya
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Nagaoka
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Nagoya
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Niigata
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Obihiro
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Sapporo
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Tachikawa
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Takatsuki
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Tsu
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Yabu
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Yanagawa
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Yatsushiro
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Yonezawa
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Manila
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Pasay City
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Philippines
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Quezon City
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Poland
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Krakow
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Proszowice
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Poland
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Tarnov
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Poland
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Warsaw
Country [80] 0 0
Russian Federation
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Barnaul
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Nizhny Novogorod
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Russian Federation
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Samara
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Saratov
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Russian Federation
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St. Petersburg
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Ufa
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Slovakia
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Bardejov
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Bojnice
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Bratislava
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Slovakia
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Humenne
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Slovakia
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Kosice
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Slovakia
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Liptovsky Hradok
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Slovakia
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Partizanske
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Slovakia
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Prievidza
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Slovakia
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Spisska Nova Ves
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Slovakia
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Trstena
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Slovakia
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Zilina
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Slovakia
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Zvolen
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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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Johannesburg
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South Africa
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Lyttleton
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South Africa
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Pretoria
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Spain
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Alcira
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Badalona
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Spain
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Barcelona
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Canet de Mar
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Spain
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Centelles
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Spain
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Ferrol
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Spain
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Fuenlabrada
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Spain
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Les Borges del Camp
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Spain
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Madrid
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Spain
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Mataro
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Spain
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Merida
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Spain
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Mostoles
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Spain
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Motril
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Spain
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Palma de Mallorca
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Spain
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Ponferrada
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Spain
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Salamanca
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Spain
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Salt
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Spain
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Valencia
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Spain
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Vic
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Switzerland
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Basel
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Switzerland
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Lugano
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Munchenstein
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Neuchatel
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Switzerland
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Zurich
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Taiwan
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Chai-Yi
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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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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Bolu
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Turkey
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Bursa
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Turkey
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Canakkale
Country [139] 0 0
Turkey
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Denizli
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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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Kocaeli
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Turkey
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Manisa
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Turkey
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Mersin
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United Kingdom
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Bath
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United Kingdom
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Blackpool
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Bradford
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Cambs
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Chelmsford
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Chesterfield
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Glasgow
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Herts
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Isle of Wight
Country [154] 0 0
United Kingdom
State/province [154] 0 0
London

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01202188