Clinical trial NCT00535366: Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD
Official title: A Randomised, Phase II, Double-Blind, Double-Dummy, Four-period Crossover Efficacy and Safety Comparison of 4-Week Treatment Periods of Blinded Fluticasone (500 mcg Bid, MDI), Ciclesonide (400 mcg qd, MDI), Ciclesonide (800 mcg qd, MDI) or Placebo in Free Combination With Open-Label Tiotropium (18 mcg qd, HandiHaler) and Salmeterol (50 mcg Bid, Diskus) in Patients With COPD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 103
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This efficacy and safety study compares four different combinations of blinded inhaled steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic obstructive pulmonary disease (COPD). The primary objective is the effect on lung function parameters.


Eligibility criteria: Inclusion Criteria:

* Relatively stable, moderate to severe COPD
* Male or female patients 40 years of age or older.
* Current or ex-smokers with a smoking history of more than 10 pack years

Exclusion Criteria:

* Other significant disease that can influence the study results or be a safety risk for the patient
* Other medication that can influence the study results
* Hypersensitivity to the study medication
* Patients with unstable COPD

Primary outcomes:
measure: Trough FEV1 response at the end of each 4 week period of randomised treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: Trough forced vital capacity (FVC) response after 4 weeks of each blinded treatment
timeFrame: after 4 weeks of each blinded treatment
measure: All adverse events
timeFrame: 24 weeks
measure: Pulse rate and blood pressure (seated)
timeFrame: 24 weeks
measure: FEV1 and FVC morning peak response
timeFrame: day 1 and day 28 of each blinded treatment
measure: FEV1 and FVC evening peak response
timeFrame: day 1 and day 28 of each blinded treatment
measure: FEV1 AUC (0-3h), after 4 weeks of each blinded treatment
timeFrame: after 4 weeks of each blinded treatment
measure: FEV1 AUC (12-15h) after 4 weeks of each blinded treatment
timeFrame: after 4 weeks of each blinded treatment
measure: FVC AUC (0-3h) after 4 weeks of each blinded treatment
timeFrame: after 4 weeks of each blinded treatment
measure: FVC AUC (12-15h) after 4 weeks of each blinded treatment
timeFrame: after 4 weeks of each blinded treatment
measure: Trough and peak inspiratory capacity (IC) and vital capacity (VC) response in the morning of day 1 and at day 28 of each treatment period
timeFrame: day 1 and day 28 of each blinded treatment
measure: Weekly mean pre-dose morning and evening peak expiratory flow (PEF)
timeFrame: 28 weeks
measure: Weekly mean number of occasions of rescue therapy used per day
timeFrame: 28 weeks
measure: Mahler Dyspnea Indices (TDI) collected at the end of each treatment period and each wash-out period
timeFrame: 28 weeks
measure: Fractional exhaled nitric oxide after 4 weeks of each blinded treatment
timeFrame: after 4 weeks of each blinded treatment
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: 1249.1.32003 Boehringer Ingelheim Investigational Site
city: Gent
country: Belgium
facility: 1249.1.32001 Boehringer Ingelheim Investigational Site
city: Hasselt
country: Belgium
facility: 1249.1.32002 Boehringer Ingelheim Investigational Site
city: Oostende
country: Belgium
facility: 1249.1.32004 Boehringer Ingelheim Investigational Site
city: Aarhus C
country: Denmark
facility: 1249.1.45001 Boehringer Ingelheim Investigational Site
city: Großhansdorf
country: Germany
facility: 1249.1.49001 Boehringer Ingelheim Investigational Site
city: Mannheim
country: Germany
facility: 1249.1.49002 Boehringer Ingelheim Investigational Site
city: Weinheim
country: Germany
facility: 1249.1.49003 Boehringer Ingelheim Investigational Site
city: Eindhoven
country: Netherlands
facility: 1249.1.31002 Boehringer Ingelheim Investigational Site
city: Harderwijk
country: Netherlands
facility: 1249.1.31003 Boehringer Ingelheim Investigational Site
city: Heerlen
country: Netherlands
facility: 1249.1.31001 Boehringer Ingelheim Investigational Site
city: Veldhoven
country: Netherlands
facility: 1249.1.31004 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: