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

Last updated: March 19, 2013
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01294787
CQVA149A2305
2010-022721-14
  • Ages > 40
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 LungDisease (GOLD) Guidelines (2009)

  • Qualifying spirometry, Forced Expiratory Volume in one second (FEV1) andpost-bronchodilator FEV1/FVC (Forced Vital capacity)

  • Smoking history ≥ 10 pack years

Exclusion

Exclusion Criteria:

  • Pregnant women or nursing mothers or women of child-bearing potential not usingadequate 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

Study Design

Total Participants: 85
Study Start date:
February 01, 2011
Estimated Completion Date:
November 30, 2011

Connect with a study center

  • Novartis Investigative Site

    Frankfurt,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Grosshansdorf,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Lubeck,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mainz,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Rudersdorf,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wiesbaden,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Alicante,
    Spain

    Site Not Available

  • Novartis Investigative Site

    Badalona,
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barakaldo,
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona,
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid,
    Spain

    Site Not Available

  • Novartis Investigative Site

    Malaga,
    Spain

    Site Not Available

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