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Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00570778
First received: December 10, 2007
Last updated: January 23, 2013
Last verified: January 2013

December 10, 2007
January 23, 2013
December 2007
September 2008   (final data collection date for primary outcome measure)
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7 [ Time Frame: Baseline, Day 7 ] [ Designated as safety issue: No ]
Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.
The mean change from baseline to 24 hr post-dose of (trough) forced expiratory volume in 1 second (FEV1) after 7 days of treatment with QVA149 compared to placebo treatment. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00570778 on ClinicalTrials.gov Archive Site
  • Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.
  • Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events [ Time Frame: 47 days ] [ Designated as safety issue: No ]
    Additional information about adverse events can be found in the Adverse Event Section.
  • Trough FEV1, FEV1 and Forced Vital Capacity (FVC), standardized FEV1 Area Under Curve (AUC), Inspiratory Capacity (IC); rescue medication usage [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Safety assessments will include vital signs, electrocardiograms (ECG) and adverse events (AEs). [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Randomized, Double-blind, Placebo Controlled, Multicentre Study to Determine the Effect of QVA149 on Lung Function in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease (COPD)
  • Drug: indacaterol/glycopyrrolate
    Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days.
    Other Name: QVA149
  • Drug: indacaterol
    Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
    Other Name: QAB149
  • Drug: placebo
    Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
  • Experimental: indacaterol/glycopyrrolate 300/50 μg
    One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
    Intervention: Drug: indacaterol/glycopyrrolate
  • Active Comparator: indacaterol 600 μg
    Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
    Intervention: Drug: indacaterol
  • Active Comparator: indacaterol 300 μg
    One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
    Intervention: Drug: indacaterol
  • Placebo Comparator: placebo
    Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
    Intervention: Drug: placebo
van Noord JA, Buhl R, Laforce C, Martin C, Jones F, Dolker M, Overend T. QVA149 demonstrates superior bronchodilation compared with indacaterol or placebo in patients with chronic obstructive pulmonary disease. Thorax. 2010 Dec;65(12):1086-91. Epub 2010 Oct 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
  2. Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
  3. Patients who have smoking history of at least 10 pack years.
  4. Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and < 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.70.

Exclusion Criteria:

  1. Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
  2. Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
  3. Patients who have had a respiratory tract infection within 6 weeks prior to screening.
  4. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
  5. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 400/mm3.
  6. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
  7. Patients with uncontrolled Type I and Type II diabetes.
  8. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
  9. Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
  10. Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (>450 ms for males or >470 ms for females).
  11. Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.

Other protocol-defined inclusion/exclusion criteria may apply.

Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Germany,   Netherlands
 
NCT00570778
CQVA149A2204
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP