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Efficacy and Safety Comparison of Tiotropium Daily + Salmeterol Daily or Twice Daily Versus Tiotropium Daily in Patients With COPD

NCT00662792 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2022-06-28

Study results available
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Summary

The primary objective of this trial is to establish superiority of the once-daily Tiotropium plus Salmeterol Inhalation Powder in daytime lung function response and non-inferiority in night-time lung function response over the comparator treatments inhaled in their established dose regimens when administered for 6-week periods to patients with chronic obstructive pulmonary disease (COPD). The main secondary objective is to evaluate the safety of the Tiotropium plus Salmeterol Inhalation Powder versus the comparator treatments.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Tiotropium (Tio18GEL)

18 µg Tiotropium (Tio18GEL) inhalation powder

DRUG

Salmeterol MDPI (Salm50DPI)

50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID)

DRUG

Tiotropium (T18GEL) + Salmeterol MDPI (S_DPI)

18 µg Tiotropium (T18GEL) inhalation powder plus 50 µg Salmeterol MDPI (S\_DPI) twice daily (BID)

DRUG

Tiotropium/Salmeterol (T+S_PE)

Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) inhalation powder

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-15
Primary Completion
2009-07-22
Completion
2009-07-22

Countries

  • Germany

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 NCT00662792 on ClinicalTrials.gov