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Efficacy, Safety, and Tolerability of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01613326 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 657

Last updated 2014-04-23

Study results available
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Summary

This study compared the efficacy and safety of NVA237 with tiotropium in patients with moderate to severe COPD. Tiotropium belongs to the same drug class as NVA237.

Conditions

Interventions

DRUG

NVA237

NVA237 50 μg inhalation capsules once a day, delivered via SDDPI

DRUG

Tiotropium

Tiotropium 18 μg once a day delivered via HandiHaler® device

DRUG

Placebo to tiotropium

Placebo to tiotropium 18 μg o.d. once a day delivered via HandiHaler® device.

DRUG

Placebo to NVA237

Placebo to NVA237 50 μg once a day delivered via SDDPI

DRUG

salbutamol/albuterol

salbutamol/albuterol given as a rescue medication via inhaler when needed

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Canada
  • Croatia
  • Czechia
  • Estonia
  • France
  • Germany
  • Guatemala
  • India
  • Latvia
  • Lithuania
  • Philippines
  • Poland
  • South Africa
  • South Korea
  • Taiwan

Study Locations

More Related Trials

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 NCT01613326 on ClinicalTrials.gov