Randomised, double-blind, placebo-controlled, 3-way cross-over study to determine the effect of 6 weeks treatment of orally inhaled BI 1744 CL (5 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]) delivered by the Respimat® Inhaler on exercise endurance time during constant work rate cycle ergometry in patients with Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 12.0Level: LLTClassification code 10009033Term: Chronic obstructive pulmonary disease
- Registration Number
- EUCTR2009-014395-21-FR
- Lead Sponsor
- Boehringer Ingelheim France
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions
2. All patients must have a diagnosis of chronic obstructive pulmonary disease (P06-12085) and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 <80% of predicted normal (ECSC, Quanjer et al, Eur Respir J, 1993) and a post-bronchodilator FEV1/FVC <70% at Visit 1 (ECSC predicted normal equations)
3. Male or female patients, between 40 and 75 years of age
4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years:
Pack Years = Number of cigarettes/day
20 cigarettes/packx years of smoking
Patients who have never smoked cigarettes must be excluded
5. Patients must be able to perform technically acceptable pulmonary function tests (body plethysmography, spirometry), must be able to complete multiple symptom-limited cycle ergometry tests, and must be able to maintain records (Patient Daily Diary) during the study period as required in the protocol
6. Patients must be able to inhale medication in a competent manner from the Respimat® inhaler and from a metered dose inhaler (MDI)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient’s ability to participate in the study
2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients)
3. Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma. If a patient has a total blood eosinophil count 600/mm3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition.
4. Patients with any of the following conditions:
- a diagnosis of thyrotoxicosis (due to the known class side effect profile of
ß2-agonists)
- a diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of ß2-agonists)
5. Patients with any of the following conditions:
-a history of myocardial infarction within 1 year of screening visit (Visit 1)
-unstable or life-threatening cardiac arrhythmia.
-hospitalized for heart failure within the past year.
-known active tuberculosis
-a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed)
-a history of life-threatening pulmonary obstruction
-a history of cystic fibrosis
-clinically evident bronchiectasis
-a history of significant alcohol or drug abuse
-any contraindications for exercise testing as outlined below
6. Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1)
7. Patients being treated with any of the following concomitant medications:
-oral ß-adrenergics
-oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
8. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator’s opinion will be unable to abstain from the use of oxygen therapy during clinic visits
9. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program
10. Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea, such as arthritis in the leg, angina pectoris or claudication or morbid obesity.
11. Patients with known hypersensitivity to ß-adrenergics drugs, BAC, EDTA or any other component of the Respimat® inhalation solution delivery system
12. Pregnant or nursing women
13. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier). Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years
Note:
1. Extreme caution sho
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method