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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
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Kaohsiung
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Bursa
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Canakkale
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Denizli
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Istanbul
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Izmir
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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
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United Kingdom
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Bradford
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United Kingdom
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Cambs
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United Kingdom
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Chelmsford
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United Kingdom
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Chesterfield
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United Kingdom
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Glasgow
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United Kingdom
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Herts
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United Kingdom
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Isle of Wight
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United Kingdom
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London

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.
Trial website
https://clinicaltrials.gov/study/NCT01202188
Trial related presentations / publications
Kulich K, Keininger DL, Tiplady B, Banerji D. Symptoms and impact of COPD assessed by an electronic diary in patients with moderate-to-severe COPD: psychometric results from the SHINE study. Int J Chron Obstruct Pulmon Dis. 2015 Jan 7;10:79-94. doi: 10.2147/COPD.S73092. eCollection 2015.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01202188