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Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01604278 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 449

Last updated 2014-11-14

Study results available
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Summary

This study assessed the efficacy, safety and tolerability of the co-administration of NVA237 plus indacaterol taken once daily versus indacaterol taken once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

NVA237 50 µg and indacaterol 150 µg

NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.

DRUG

Placebo to NVA237 and indacaterol 150 µg

Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Belgium
  • Bulgaria
  • Greece
  • Hungary
  • Ireland
  • Russia
  • Slovakia
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01604278 on ClinicalTrials.gov