Trial record 1 of 1 for:    NCT01294787.
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Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BRIGHT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01294787
First received: February 10, 2011
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

This study assessed the effect of once-daily indacaterol and glycopyrronium bromide (QVA149) on exercise endurance in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).


Condition Intervention Phase
COPD
Drug: indacaterol and glycopyrronium bromide (QVA149)
Drug: placebo
Drug: tiotropium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded, Double Dummy, Multi-center, Placebo Controlled, 3 Period, Crossover Study to Assess the Effect of QVA149 (110/50 µg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Exercise Tolerance Comparison Between QVA149 and Placebo Groups [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured by exercise endurance time (in seconds) during a sub-maximal constant load cycle ergometry test ((SMETT)which is a cycle exercise test) after three weeks of treatment.


Secondary Outcome Measures:
  • Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity at isotime during sub-maximal constant load cycle ergometry test ((SMETT)a cycle exercise test), after three weeks of treatment.

  • Trough 24 Hour Post Dose Inspiratory Capacity Comparison Between QVA149 and Placebo Groups [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose inspiratory capacity after three weeks of treatment.

  • Trough 24 Hour Post Dose Forced Expiratory Volume in One Second Comparison Between QVA149 and Placebo Groups [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose Forced Expiratory Volume in one second (FEV1) after three weeks of treatment.

  • Pulmonary Function Test Comparison Between QVA149 and Placebo Groups [ Time Frame: day 1 and day 21 ] [ Designated as safety issue: No ]
    The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Slow Vital Capacity (SVC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.

  • Pulmonary Function Test (RV) Comparison Between QVA149 and Placebo Groups [ Time Frame: day 1 and day 21 ] [ Designated as safety issue: No ]
    The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Residual Volume (RV) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.

  • Pulmonary Function Test (SGaw) Comparison Between QVA149 and Placebo Groups [ Time Frame: day 1 and day 21 ] [ Designated as safety issue: No ]
    The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Specific Airway Conductance (SGaw) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.

  • Pulmonary Function Test (FRC) Comparison Between QVA149 and Placebo Groups [ Time Frame: day 1 and day 21 ] [ Designated as safety issue: No ]
    The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Functional Residual Capacity (FRC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.

  • Spirometry After Three Weeks of Treatment on Patients Not Exercising [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity post-dose pre-exercise after three weeks of treatment.

  • Exertional Dyspnea Comparison Between QVA149 and Placebo Groups [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

    The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using exertional dyspnea Borg CR10 Scale® (After 3 weeks of treatment, before, during and after exercise, patients were asked to rate the intensity of their breathing and leg discomfort using the Borg CR10 Scale®). This scale consists of 12-point score that the participants pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).

    A reduction in this score indicates an improvement.


  • Leg Discomfort During Exercise Comparison Between QVA149 and Placebo Groups [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo on leg discomfort was measured using Borg CR10 Scale® during sub-maximal constant load cycle ergometry test after three weeks treatment.

  • Exercise Endurance Comparison Between QVA149 and Tiotropium Groups [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Effect of QVA149 110/50 µg o.d. compared with tiotropium 18 µg o.d. in patients with moderate to severe COPD with respect to exercise endurance was measured by a sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test) after three weeks of treatment.

  • Exercise Endurance Time Comparison After a Single Dose of QVA149 Versus Placebo [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The effect of a single dose of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured with respect to exercise endurance time during sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test).


Enrollment: 85
Study Start Date: February 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: indacaterol and glycopyrronium bromide (QVA149)
QVA149 delivered once daily via single-dose dry powder inhaler.
Drug: indacaterol and glycopyrronium bromide (QVA149)
Placebo Comparator: placebo
Placebo, delivered once daily via single-dose dry powder inhaler.
Drug: placebo
Active Comparator: tiotropium
Tiotropium delivered once daily via HandiHaler® device.
Drug: tiotropium

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) stage II or stage III according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2009)
  • Qualifying spirometry, Forced Expiratory Volume in one second (FEV1) and post-bronchodilator FEV1/FVC (Forced Vital capacity)
  • Smoking history ≥ 10 pack years

Exclusion Criteria:

  • Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception
  • Cardiac abnormality
  • History of asthma
  • Contraindications to cardiopulmonary exercise testing
  • Participation in active phase of pulmonary rehabilitation program
  • History of cancer within the past 5 years

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294787

Locations
Germany
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
Grosshansdorf, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Lubeck, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
Rudersdorf, Germany
Novartis Investigative Site
Wiesbaden, Germany
Spain
Novartis Investigative Site
Alicante, Spain
Novartis Investigative Site
Badalona, Spain
Novartis Investigative Site
Barakaldo, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Malaga, Spain
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01294787     History of Changes
Other Study ID Numbers: CQVA149A2305, 2010-022721-14
Study First Received: February 10, 2011
Results First Received: November 29, 2012
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration
Germany: Bunesinstitut fur Arzneimittel und Medizinprodukte Agencia
Spain: Espanola de medicamentos y productos sanitarios

Keywords provided by Novartis:
COPD
QVA149
tiotropium
exercise
exercise tolerance
combination bronchodilator
moderate to severe COPD

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Glycopyrrolate
Tiotropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 23, 2014