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Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol Polyethylene (PE) Capsule) in Chronic Obstructive Pulmonary Disease (COPD)

NCT00662740 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2023-08-23

No results posted yet for this study

Summary

The primary objectives of this study are to assess bronchodilator efficacy as determined by forced expiratory volume in one second (FEV1), the effect on dyspnoea as determined by the Baseline Dyspnoea Index/Transition Dyspnoea Index (BDI/TDI), the effect on health status as determined by the St George Respiratory Questionnaire (SGRQ) and the effect on chronic obstructive pulmonary disease (COPD) exacerbations.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Tiotropium/Salmeterol QD

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule

DRUG

Placebo

Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

DRUG

Salmeterol

Salmeterol Inhalation Powder, hard PE capsule

DRUG

Tiotropium/Salmeterol QD+ Salmeterol

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule

DRUG

Tiotropium (Spiriva®)

Tiotropium, Spiriva®

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-15
Primary Completion
2008-11-21
Completion
2008-11-21

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Slovakia
  • South Korea
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
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 NCT00662740 on ClinicalTrials.gov