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Clinical Trials/NL-OMON37459
NL-OMON37459
Completed
Phase 3

A study to compare the efficacy and safety of once daily QVA149 vs. the once daily concurrent administration of QAB149 plus NVA237 in patients with moderate to severe chronic obstructive pulmonary disease (CQVA149A2326) - CQVA149A2326

ovartis Pharma BV0 sites70 target enrollmentTBD
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ConditionsCOPDchronic obstructive pulmonary disease10038716

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
COPD
Sponsor
ovartis Pharma BV
Enrollment
70
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
ovartis Pharma BV

Eligibility Criteria

Inclusion Criteria

  • •Male or female adults aged \>\=40 years.
  • •Patients with moderate to severe COPD (Stage II\-III) according to the (GOLD Guidelines, 2010\).
  • •Current or ex\-smokers who have a smoking history of at least 10 pack years.
  • •Post\-bronchodilator FEV1 \>\=30% of the predicted normal value, and postbronchodilator FEV1/FVC \< 0\.70\.
  • •COPD symptoms during run\-in phase.

Exclusion Criteria

  • •Diabetes type I and uncontrolled diabetes type 2\.
  • •History of long QT syndrome or QTc measured at Visit 2 (Fridericia method) is prolonged (\>450 ms for males and females).
  • •BMI \>\=40 kg/m2\.
  • •Patients who have had a COPD exacerbation in the 6 weeks prior to Visit 1\.
  • •Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1\.
  • •Pregnancy and breast feeding. Inadequate contraception, if relevant.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Comparison of safety and efficacy of the combination product QVA149A against the concurrent administration of the individual components, QAB149 and NVA237, in patients with chronic obstructive pulmonary disease (COPD)
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