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Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01119950 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2015-03-23

Study results available
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Summary

This study was designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD.

Conditions

Interventions

DRUG

NVA237 12.5 µg once daily

NVA237 12.5 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

DRUG

NVA237 25.0 µg once daily

NVA237 25.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

DRUG

NVA237 12.5 µg twice daily

NVA237 12.5 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.

DRUG

NVA237 50.0 µg once daily

NVA237 50.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

DRUG

NVA237 25.0 µg twice daily

NVA237 25.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.

DRUG

NVA237 100.0 µg once daily

NVA237 100.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

DRUG

NVA237 50.0 µg twice daily

NVA237 50.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.

DRUG

Placebo to NVA237 once daily

Placebo to NVA237 via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States
  • Belgium
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • Spain

Study Locations

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Entities

Diseases
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 NCT01119950 on ClinicalTrials.gov