RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL CROSSOVER TRIAL IN ADULT ASTHMATICS EVALUATING THE EFFECT OF CONCOMITANT TWO WEEKS TREATMENT WITH MONTELUKAST (SINGULAIR™) 10 MG ONCE DAILY OR MATCHING PLACEBO TO PREVENT THE DEVELOPMENT OF TOLERANCE TO BRONCHOPROTECTION AND BRONCHODILATION BY BETA-AGONISTS OCCURRING AFTER TWO WEEKS REGULAR TREATMENT WITH SALMETEROL (SEREVENT™) 50µG B.I.D. - PREDATOR
- Conditions
- Intermittend or mild asthma according to the definition of the Global Initiative ofor Asthma (GINA) guidelines step 1 or step 2 (2004)
- Registration Number
- EUCTR2005-003991-39-DE
- Lead Sponsor
- insaf, Institut für Atemwegsforschung GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
intermittent or mild persistent asthmatics (GINA step 1 and 2, GINA 2004)
positive skin test to more or equal to 1 allergen within the last 12 months prior to screening or at screening visit
PC20 methacholine below or equal to 4 mg/ml at screening
FEV1 >85% pred
Asthma medication: only short-acting beta-agonists prn
written informed consent
patients who, with the exception of asthma, are in good health
clinical stable asthma
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
asthma severity > step 2 GINA
history of lower or upper airway infection in the last 4 weeks prior to screening
diagnosis of chronic obstructive pulmonary disease (COPD) and/or other relevant lung dis-eases (e. g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease and active tuberculosis)
current smoker and ex-smokers with more than 10 pack years*
(* 1 pack year is defined as 20 cigarettes/day for 1 year.)
clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (assessed by the investigator)
suspected hypersensitivity and / or contraindication to any ingredients of the study medication and / or the rescue medication
use of prohibited medication prior to screening and throughout the study
wash-out times of drugs defined in protocol cannot be adhered to
alcohol and / or drug abuse
pregnancy, breast feeding
women of childbearing potential need to practice a safe contraception during the entire course of the study
participation in another clinical trial within 30 days preceding the screening visit
patients not able to follow study procedures (e.g. language problems, psychological disorders)
suspected non-compliance
known hypersensitivity to Montelukast, SereventTM Diskus, or Salbutamol MDI or any of the ingredients
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