Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: Tiotropium (Drug); Salmeterol (Drug); Fluticasone (Drug); Ciclesonide low (Drug); Ciclesonide high (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s): Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Trough FEV1 response at the end of each 4 week period of randomised treatment
Secondary outcome: Trough forced vital capacity (FVC) response after 4 weeks of each blinded treatmentAll adverse events Pulse rate and blood pressure (seated) FEV1 and FVC morning peak response FEV1 and FVC evening peak response FEV1 AUC (0-3h), after 4 weeks of each blinded treatment FEV1 AUC (12-15h) after 4 weeks of each blinded treatment FVC AUC (0-3h) after 4 weeks of each blinded treatment FVC AUC (12-15h) after 4 weeks of each blinded treatment 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 Weekly mean pre-dose morning and evening peak expiratory flow (PEF) Weekly mean number of occasions of rescue therapy used per day Mahler Dyspnea Indices (TDI) collected at the end of each treatment period and each wash-out period Fractional exhaled nitric oxide after 4 weeks of each blinded treatment
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
1249.1.32003 Boehringer Ingelheim Investigational Site, Genk, Belgium
1249.1.32001 Boehringer Ingelheim Investigational Site, Gent, Belgium
1249.1.32002 Boehringer Ingelheim Investigational Site, Hasselt, Belgium
1249.1.32004 Boehringer Ingelheim Investigational Site, Oostende, Belgium
1249.1.45001 Boehringer Ingelheim Investigational Site, Aarhus C, Denmark
1249.1.49001 Boehringer Ingelheim Investigational Site, Großhansdorf, Germany
1249.1.49002 Boehringer Ingelheim Investigational Site, Mannheim, Germany
1249.1.49003 Boehringer Ingelheim Investigational Site, Weinheim, Germany
1249.1.31002 Boehringer Ingelheim Investigational Site, Eindhoven, Netherlands
1249.1.31003 Boehringer Ingelheim Investigational Site, Harderwijk, Netherlands
1249.1.31001 Boehringer Ingelheim Investigational Site, Heerlen, Netherlands
1249.1.31004 Boehringer Ingelheim Investigational Site, Veldhoven, Netherlands
Additional Information
Starting date: October 2007
Last updated: May 22, 2014
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