Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00535366
First received: September 25, 2007
Last updated: May 28, 2009
Last verified: May 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: Tiotropium Drug: salmeterol Drug: steroid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Trough FEV1 response at the end of each 4 week period of randomised treatment [ Time Frame: 4 weeks ]
Secondary Outcome Measures:
- Other lung function parameters such as FVC, IC, VC, PEF, DLCO, FENO Occasions of rescue therapy Mahler Dyspnea Indices Safety [ Time Frame: 4 weeks ]
| Enrollment: | 103 |
| Study Start Date: | October 2007 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535366
Locations
| Belgium | |
| 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 | |
| Denmark | |
| 1249.1.45001 Boehringer Ingelheim Investigational Site | |
| Aarhus C, Denmark | |
| Germany | |
| 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 | |
| Netherlands | |
| 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 | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00535366 History of Changes |
| Other Study ID Numbers: | 1249.1, Eudract2007-003169-42 |
| Study First Received: | September 25, 2007 |
| Last Updated: | May 28, 2009 |
| Health Authority: | Belgium: Federal Agency for Medicines and Health Products, FAMHP Denmark: The Danish Medicine Agency Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medical devices) Netherlands: Central Committee on Research Involving Human Subjects (CCMO) |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Lung Diseases, Obstructive Salmeterol Tiotropium Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Parasympatholytics Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on June 18, 2013