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Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients

NCT01969721 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 229

Last updated 2016-02-12

Study results available
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Summary

The objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol FDC \[2.5/ 5µg and 5/ 5µg\] delivered by the RESPIMAT with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol FDC \[250/50µg and 500/50µg\] delivered by the Accuhaler® after 6 weeks of treatment.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

fluticasone propionate

low dose

DRUG

salmeterol

DRUG

placebo

placebo/dummy for blinding purposes

DRUG

placebo

placebo/dummy for blinding purposes

DRUG

tiotropium

tiotropium high dose

DRUG

olodaterol

DRUG

olodaterol

DRUG

placebo

placebo/dummy for blinding purposes

DRUG

placebo

placebo/dummy for blinding purposes

DRUG

tiotropium

tiotropium low dose

DRUG

fluticasone propionate

low dose

DRUG

salmeterol

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
2013-10-31
Primary Completion
2015-01-31
Completion
2015-02-28

Countries

  • Belgium
  • Czechia
  • Denmark
  • Germany
  • Hungary
  • Netherlands
  • Spain
  • 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 NCT01969721 on ClinicalTrials.gov