Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
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
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Purpose
This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: indacaterol/glycopyrrolate Drug: indacaterol Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 154 |
| Study Start Date: | December 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
|
|
Active Comparator: indacaterol 600 μg
Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
|
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
|
|
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.
|
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
|
|
Placebo Comparator: placebo
Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Drug: placebo
Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
- Patients who have smoking history of at least 10 pack years.
- 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:
- 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.
- 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.
- Patients who have had a respiratory tract infection within 6 weeks prior to screening.
- Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
- Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 400/mm3.
- Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
- Patients with uncontrolled Type I and Type II diabetes.
- History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
- Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
- 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).
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570778
Locations
| United States, Missouri | |
| Novartis Investigator Site | |
| St Louis, Missouri, United States | |
| United States, North Carolina | |
| Novartis Investigator Site | |
| Charlotte, North Carolina, United States | |
| Novartis Investigator site | |
| Raleigh, North Carolina, United States | |
| Belgium | |
| Novartis Investigator Site | |
| Antwerpen, Belgium | |
| Novartis Investigator Site | |
| Gent, Belgium | |
| Novartis Investigator Site | |
| Jambes, Belgium | |
| Novartis Investigator Site | |
| Saint Vith, Belgium | |
| Canada | |
| Novartis Investigator Site | |
| Moncton, Canada | |
| Novartis Investigator Site | |
| Montreal, Canada | |
| Novartis Investigator site | |
| Toronto, Canada | |
| Germany | |
| Novartis Investigator Site | |
| Bad Worishofen, Germany | |
| Novartis Investigator Site | |
| Berlin, Germany | |
| Novartis Investigator Site | |
| Frankfurt, Germany | |
| Novartis Investigator Site | |
| Mainz, Germany | |
| Novartis Investigator Site | |
| Rudersdorf, Germany | |
| Novartis Investigator Site | |
| Wiesbaden, Germany | |
| Netherlands | |
| Novartis Investigator Site | |
| Almelo, Netherlands | |
| Novartis Investigator Site | |
| Breda, Netherlands | |
| Novartis Investigator site | |
| Eindhoven, Netherlands | |
| Novartis investigator site | |
| Heerlen, Netherlands | |
| Novartis Investigator Site | |
| Nijmegen, Netherlands | |
| Novartis Investigator Site | |
| Veldhoven, Netherlands | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00570778 History of Changes |
| Other Study ID Numbers: | CQVA149A2204 |
| Study First Received: | December 10, 2007 |
| Results First Received: | October 23, 2012 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Netherlands: Medicines Evaluation Board (MEB) Germany: Federal Institute for Drugs and Medical Devices Canada: Health Canada |
Keywords provided by Novartis:
|
QVA, Indacaterol, Glycopyrrolate, Concept1, COPD, cross over study, safety and efficacy, trough FEV1 |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Glycopyrrolate Adjuvants, Anesthesia Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013