Intermittend or mild asthma according to the definition of the Global Initiative ofor Asthma (GINA) guidelines step 1 or step 2 (2004)
Conditions
Interventions
Trade Name: Singulair
Product Name: Singulair
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Montelukast
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
insaf, Institut für Atemwegsforschung GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to investigate the effects of addition of Montelukast (Singulair™ 10 mg o.d.) to regular treatment (14 days) with the long-acting beta-agonist Salmeterol (Serevent™ 50µg b.i.d.) in patients with intermittent or mild asthma on: development of tolerance to bronchoprotection against methacholine-induced bronchoconstric-tion achieved by 50 µg salmeterol DPI development of tolerance to bronchodilation (acute reversal of methacholine-induced broncho-constriction) achieved by 400µg salbutamol MDI ;Secondary Objective: to investigate the effects of addition of Montelukast (Singulair™ 10 mg o.d.) to regular treatment (14 days) with the long-acting beta-agonist Salmeterol (Serevent™ 50µg b.i.d.) in patients with intermittent or mild asthma on: correlation of breath condensate and induced sputum airway cys-LT concentrations and devel-opment of tolerance to beta-agonists in asthmatic subjects. Cys-LT concentrations in EBC after montelukast vs. placebo Exhaled nitric oxide levels after montelukast vs. placebo;Primary end point(s): Protection afforded by a single dose of 50µg Salmeterol against methacholine-induced bronchocon-striction after 14 days of regular treatment with Salmeterol (50 µg bid) alone or in combination with Montelukast. This will be measured (a) as the post-Salmeterol PC20 methacholine (mg/ml) on day 14 in treatment period (TP) A vs TP B, and (b) as the degree of tolerance expressed as relative change in post-Salmeterol PC20 methacholine (doubling concentrations) from day 1 to day 14 dur-ing TP A vs TP B. Co-primary endpoint This will be the acute rescue bronchodilator effect of 400µg salbutamol measured as (a) % change and (b) AUC of FEV1 5, 10, 15, 30, and 45 minutes after methacholine-induced bronchoconstric-tion on day 14 during TP A vs TP B | — |
Countries
Germany
Outcome results
None listed