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Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disorder (COPD)
This study has been completed.
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00570778
  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: QVA149
Drug: Indacaterol
Drug: placebo
Phase II

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Indacaterol Glycopyrrolate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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)

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Trough FEV1, FEV1 and Forced Vital Capacity (FVC), standardized FEV1 Area Under Curve (AUC), Inspiratory Capacity (IC); rescue medication usage
  • Safety assessments will include vital signs, electrocardiograms (ECG) and adverse events (AEs).

Estimated Enrollment: 140
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
1: Active Comparator Drug: QVA149
2: Active Comparator Drug: Indacaterol
3: Active Comparator Drug: Indacaterol
4: Placebo Comparator Drug: placebo

  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 COPD according to the GOLD Guidelines 2006.
  3. Patients who have smoking history of at least 10 pack years.
  4. Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal and post-bronchodilator FEV1/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 (> 15h 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
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
Raleigh, North Carolina, United States
Novartis Investigator Site
Charlotte, North Carolina, United States
Belgium
Novartis Investigator Site
Antwerpen, Belgium
Novartis Investigator Site
Gent, Belgium
Novartis Investigator Site
Gembloux, Belgium
Novartis Investigator Site
Saint Vith, Belgium
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
Veldhoven, Netherlands
Novartis Investigator site
Eindhoven, Netherlands
Novartis investigator site
Heerlen, Netherlands
Novartis Investigator Site
Nijmegen, Netherlands
Novartis Investigator Site
Breda, Netherlands
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis ( External affairs )
Study ID Numbers: CQVA149A2204
Study First Received: December 10, 2007
Last Updated: September 9, 2008
ClinicalTrials.gov Identifier: NCT00570778  
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

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Glycopyrrolate
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 13, 2009