A RANDOMIZED, PLACEBO CONTROLLED, DOUBLE-BLIND, CROSS-OVER, MONOCENTER STUDY TO EVALUATE THE EFFECT OF A 7-DAY MONTELUKAST TREATMENT ON AIRWAY INFLAMMATION AND FUNCTION BY MEANS OF BRONCHOPROVOCATION WITH ADENOSINE-5’-MONOPHOSPHATE IN PATIENTS WITH MILD OR MODERATE ALLERGIC ASTHMA - M/MTAST/01
- Conditions
- Mild to moderate asthma according to GINA (Global initiative for Asthma, 2004) guidelines.
- Registration Number
- EUCTR2006-000334-12-DE
- Lead Sponsor
- Almirall Prodesfarma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 18
1.Eighteen to seventy years old male or female patients having been diagnosed of mild or moderate allergic asthma for at least 6 months.
2.Atopy as indicated by at least one positive skin prick test to one or more common aeroallergens within the last preceding 12 months.
3.Patients must have not been treated with long-acting ß2 agonist within the last 48 hours or corticosteroids within 6 weeks prior to study entry.
4.FEV1 = 70% of predicted at screening.
5.PC20 AMP = 400 mg/ml at screening.
6.No smoking history during the last 12 months and no history of smoking more than 10 packs/year (definition: smoking history of 20 cigarettes daily for one year or of 10 cigarettes daily for 2 years etc.).
7.No concurrent treatment, except Salbutamol, may be planned during protocol treatment.
8.Normal organ and marrow function as defined at the discretion of the investigator.
9.Negative pregnancy test in women of reproductive potential.
10.Women of reproductive potential must agree to use adequate contraception prior to study entry and during the trial.
11.Ability to communicate adequately with investigators and comply with the requirements of the entire study.
12.Ability to understand and the willingness to sign an informed consent document.
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.Intubation (ever) or hospitalization for longer than 24 hours within the preceding six weeks for the management of an asthma exacerbation.
2.Asthma exacerbation within 6 weeks prior to study entry.
3.Long-acting ß2 agonist within the last 48 hours or corticosteroids within 6 weeks prior to study entry.
4.Respiratory infection within 2 preceding weeks of study entry.
5.Current use of ß antagonist.
6.Use of monoclonal antibodies for the treatment of asthma, methotrexate, gold salts, cyclosporine, tacrolimus (topical or systemic), or azathioprine within 3 months prior to study entry.
7.Participation in another investigational drug trial within the preceding 30 days of study entry.
8.History of alcohol or drug abuse.
9.Pregnancy or nursing.
10.HIV seropositivity.
11.Known hypersensitivity against Montelukast-Natrium or any other active ingredient (cellulose, lactose-monohydrate, Hypromellose, Hyprolose, Magnesiumstarate, Titandioxide, Ferrum-III-oxide (E172), Ferrumoxidehydrate (E 172), Carnaubawax).
12.Severe dysfunction of the liver.
13.Hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
14.Use of Phenobarbital, Phenytoin, Rifampicin.
15.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic intracranial disease, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
16.History of severe neurological, cardiovascular, renal, hepatic, respiratory, bone marrow dysfunction, organ graft or autoimmune disease (treated or not).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of Montelukast on the provocative concentration of adenosine-5’-monophosphate (AMP) inducing a 20% decline in Forced Expiratory Volume in one second (FEV1) (referred to as PC20 AMP). ;Secondary Objective: To assess the effect of Montelukast on recovery time following AMP challenge<br><br>To assess the effect of Montelukast on non-invasive inflammatory parameters (nitric oxide measured in exhaled breath; differential cell counts, eosinophil cationic protein, Cys-leukotriens, interleukin-13 and interferon gamma measured in induced sputum and blood; leukotriene E4 measured in urine).<br><br>To validate the methodology of AMP challenge as a surrogate marker for the evaluation of the activity of anti-asthmatic drugs;Primary end point(s): Primary activity variable:<br><br>The primary activity variable is the provocative concentration of inhaled AMP required to induce a 20% decrease in FEV1 (PC20 AMP), at Day 7 after treatment.<br>
- Secondary Outcome Measures
Name Time Method