Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01294787 | Completed Phase 3 Results

• 2 other identifiers: CQVA149A23052010-022721-14
• Study Type: interventional
• Target: 85
• Locations: 2 countries
• Sites: 13

Brief Summary

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).

Conditions

COPD

Keywords

COPD; QVA149; tiotropium; exercise; exercise tolerance; combination bronchodilator; moderate to severe COPD

Outcome Measures

Primary Outcomes (1)

• Exercise Tolerance Comparison Between QVA149 and Placebo Groups

  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.

  3 weeks

Secondary Outcomes (12)

• Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups

  3 weeks

• Trough 24 Hour Post Dose Inspiratory Capacity Comparison Between QVA149 and Placebo Groups

  3 weeks

• Trough 24 Hour Post Dose Forced Expiratory Volume in One Second Comparison Between QVA149 and Placebo Groups

  3 weeks

• Pulmonary Function Test Comparison Between QVA149 and Placebo Groups

  day 1 and day 21

• Pulmonary Function Test (RV) Comparison Between QVA149 and Placebo Groups

  day 1 and day 21

Study Arms (3)

indacaterol and glycopyrronium bromide (QVA149)

EXPERIMENTAL

QVA149 delivered once daily via single-dose dry powder inhaler.

Drug: indacaterol and glycopyrronium bromide (QVA149)

placebo

PLACEBO COMPARATOR

Placebo, delivered once daily via single-dose dry powder inhaler.

Drug: placebo

tiotropium

ACTIVE COMPARATOR

Tiotropium delivered once daily via HandiHaler® device.

Drug: tiotropium

Interventions

indacaterol and glycopyrronium bromide (QVA149) DRUG

indacaterol and glycopyrronium bromide (QVA149)

placebo DRUG

placebo

tiotropium DRUG

tiotropium

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (13)

Novartis Investigative Site

Frankfurt, Germany

Location

Novartis Investigative Site

Großhansdorf, Germany

Location

Novartis Investigative Site

Hamburg, Germany

Location

Novartis Investigative Site

Lübeck, Germany

Location

Novartis Investigative Site

Mainz, Germany

Location

Novartis Investigative Site

Rüdersdorf, Germany

Location

Novartis Investigative Site

Wiesbaden, Germany

Location

Novartis Investigative Site

Alicante, Spain

Location

Novartis Investigative Site

Badalona, Spain

Location

Novartis Investigative Site

Barakaldo, Spain

Location

Novartis Investigative Site

Barcelona, Spain

Location

Novartis Investigative Site

Madrid, Spain

Location

Novartis Investigative Site

Málaga, Spain

Location

Related Publications (1)

• Beeh KM, Korn S, Beier J, Jadayel D, Henley M, D'Andrea P, Banerji D. Effect of QVA149 on lung volumes and exercise tolerance in COPD patients: the BRIGHT study. Respir Med. 2014 Apr;108(4):584-92. doi: 10.1016/j.rmed.2014.01.006. Epub 2014 Jan 21.

  PMID: 24534204 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

indacaterol; Glycopyrrolate; indacaterol-glycopyrronium combination; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

41 61 324 1111

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 11, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 20, 2013
• Results First Posted: March 20, 2013

Record last verified: 2013-03

Locations

DE (7); ES (6)