Randomised, double-blind, placebo-controlled, parallel group study to assess the efficacy (bronchodilation) and safety of 4 weeks of once daily treatment of orally inhaled BI 1744 CL (2 µg, 5 µg, 10 µg, 20 µg) delivered by the Respimat® inhaler in patients with asthma - BI 1744 CL in Asthma
- Conditions
- Patients with diagnosis of AsthmaMedDRA version: 9.0Level: LLTClassification code 10003555Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2006-004829-29-FR
- Lead Sponsor
- Boehringer Ingelheim France
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Male or female patients, 18 years of age or older
Diagnosis of asthma (GINA)
Pre-bronchodilator FEV1 greater than or equal to 60% predicted and <90% predicted (ECSC);
Increase in FEV1 greater than or equal to12% and 200 ml 15 minutes after 400µg salbutamol (albuterol) at Visit 1
Patient must have been taking ICS for at least 12 weeks prior to screening, and must have been receiving a stable low/moderate dose for at least 6 weeks prior to screening.
Patients must be able to perform technically acceptable pulmonary function tests (both supervised and unsupervised) and PEF measurements, and must be able to maintain records (Patient Daily e-Diary) during the study period as required in the protocol
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
Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >80 IU/L, SGPT >80 IU/L, bilirubin >17 µmol/L or creatinine >110 µmol/L (males) / 95 µmol/L (females) will be excluded regardless of clinical condition
Patients with a smoking history of more than 10 pack years
Patients with any of the following conditions:
a diagnosis of thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms), a history of additional risk factors for Torsade de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Patients with any of the following conditions:
a history of myocardial infarction within 1 year of screening visit, a diagnosis of clinically relevant cardiac arrhythmia, a history of cor pulmonale, 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
Patients being treated with any of the following concomitant medications:
long acting beta-agonists (LABAs) for 6 weeks prior to screening, medications that prolong the QT/QTc interval since the effects of BI 1744 CL on QT/QTc interval have yet to be characterized, oral ß-adrenergics, ß-blockers (topical ß -blockers for ocular conditions are allowed)
Women of childbearing potential not using a highly effective method of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. 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 2 years
Pregnant or nursing women
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