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Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)

NCT01089127 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 552

Last updated 2011-08-19

Study results available
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Summary

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol.

Conditions

Interventions

DRUG

Indacaterol

Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

DRUG

Salmeterol 50 μg

Salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.

DRUG

Placebo to indacaterol

Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

DRUG

Placebo to salmeterol

Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.

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
2010-03-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

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 NCT01089127 on ClinicalTrials.gov