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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
  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:

  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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Glycopyrrolate
Adjuvants, Anesthesia
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014