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Multiple Dose Comparison of Tiotropium Inhalation Capsules, Salmeterol Inhalation Aerosol and Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02172287 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 623

Last updated 2014-06-24

No results posted yet for this study

Summary

To compare the long -term (six month) bronchodilator efficacy and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo in patients with COPD. A secondary objective of this study was to compare the impact of tiotropium and salmeterol on humanistic and economic health outcomes, such as quality of life, patient preference and Health Resource Utilisation in this patient population.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Tiotropium (Ba679 BR)

One capsule once daily by oral inhalation

DRUG

Salmeterol

Inhalation aerosol twice daily

DRUG

Placebo (for Tiotropium )

Placebo for Tiotropium delivered by inhalation capsule

DRUG

Placebo (for Salmeterol)

Placebo for Salmeterol delivered by inhalation aerosol

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-02-28
Primary Completion
2000-05-31

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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 NCT02172287 on ClinicalTrials.gov