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Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00615030 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2011-08-17

Study results available
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Summary

This study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second \[FEV1\]) over the full 24-h time period

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Indacaterol

300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)

DRUG

Salmeterol

50 µg twice daily delivered via dry powder inhaler (DPI)

DRUG

Placebo to Indacaterol

Placebo matching indacaterol was delivered via SDDPI.

DRUG

Placebo to Salmeterol

Placebo matching salmeterol was delivered via DPI

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · + 41 61 324 1111

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-07-31
Completion
2008-08-31

Countries

  • France
  • Germany
  • Spain

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 NCT00615030 on ClinicalTrials.gov