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Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT00669617 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2011-09-12

Study results available
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Summary

This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg

Conditions

Interventions

DRUG

Indacaterol

Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)

DRUG

Salmeterol/fluticasone (50/500 μg)

Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

DRUG

Salbutamol (200 µg)

Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

DRUG

Placebo to Indacaterol

Placebo to indacaterol delivered via SDDPI

DRUG

Placebo to Salmeterol/fluticasone

Placebo to salmeterol/fluticasone delivered via MDDPI

DRUG

Placebo to salbutamol

Placebo to salbutamol delivered via MDDPI

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States
  • Belgium
  • Germany
  • Hungary

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 NCT00669617 on ClinicalTrials.gov