Effect of leukotriene gene polymorphisms on response to montelukast, a leukotriene receptor antagonist, in adults with asthma - ND

• Conditions: asthma; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2008-001008-21-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female adults, age 15-70 years, with persistent mild (step 2) or moderate (step 3) asthma based on guidelines for diagnosis and treatment of asthma issued by the National Heart, Lung, and Blood Institute of the National Institute of Health defined on the basis of symptoms more often than twice a week, but less than daily (step 2) or daily without therapy or more often than twice a week, but less than daily with therapy (step 3). 2. Therapy with only short acting 2-agonists administered as needed or drugs for asthma control except leukotriene receptor antagonists. 3. Baseline exhaled nitric oxide concentrations > 20 ppb. 4. Following signs and symptoms of asthma before visit 2: a. asthma symptoms with dyspnea, wheezing, chest tighteness, cough, sputum for at least 12 months. b. Pre-bronchodilator forced expiratory volume in one second (FEV1) > 80% of predicted value after bronchodilator witholding for at least 6 hours at visit 1 and 2. c. Asthma diagnosis defined as: 1) positive reversibility to bronchodilators with increase of 12% in FEV1 or PEF (absolute value), 20-30 minutes after inhalation of a 2-agonist at visit 1; or 2) positive methacholine challenge with a PC20 value  8 mg/ml performed in the previous 12 months; or 3) positive exercise test with a decrease of 15% in FEV1 performed in the previous 12 months. Reversibility test to bronchodilators, methacholine challenge and exercose test will not be repeated if performed in the previous 12 months before visit 1. 5. The person is in good general conditions and is able to complete the study and chew a tablet. 6. Ability to perform reproducible spirometry. 7. Absence of smoking history (including tobacco products) in the previous year. 8. Ability of patient to provide informed consent, as evidenced by signing a copy of the consent form approved by the institutional review board of the subject?s respective study institution 9. Women
Are the trial subjects under 18? yes
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

1. Person is unable to provide informed consent. 2. Patient is hospitalized. 3. Patient has undergone any major surgical procedure within four weeks of visit 1. 4. Patient has, in addition to asthma, any active, acute or chronic pulmonary disorder documented by history or physical examination. 5. Patient has ever been intubated for asthma, has required acute asthma therapy treated in an emergency room/urgent care facility/office setting within one month or has been hospitalized for asthma within three months of visit 1 or required 2 or more hospitalizations for asthma in the past year. 6. Patient has FEV1 < 60% predicted on visit 1. 7. Patient received 4 or more oral corticosteroid bursts for asthma exacerbations. 8. Patient has unresolved symptoms and signs of an upper respiratory tract infection (URI) within three weeks of visit 1 or during the run-in period. 9. Patient has a history of an anaphylactic allergic reaction related to administration of oral montelukast or the components of tablets. 10. Patient has a clinically significant, active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or hematological systems, or an immunodeficiency, or an autoimmune disorder. 11. Patient has a history of any illness that would require treatment with an excluded medication, could be immediately life threatening, would pose restriction on participation or successful completion of the study, or would pose an additional risk to the patient by administering montelukast. 12. Patient has taken the following medications: 1) Oral, intravenous, intramuscular, intra-articular or inhaled corticosteroids within 4 weeks of visit 1 with the exception of nasal corticosteroids administered on a continuous basis. 2) Leukotriene modifiers within 2 weeks before visit 1. 3) Received treatment within the previous 4 week with medications known to significantly interact with montelukast. 4) Antibiotics for 7 consecutive days in the 4 weeks prior to visit 1. 5) IV gammaglobulin or immunosuppressants within one month of visit 1. 13. Patient has started immunotherapy within six months of visit 1. 14. Patient is unable or unwilling to comply with the study procedures as determined during the run-in period, including compliance with study medication.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified