asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: SINGULAIR
Pharmaceutical Form: Tablet
INN or Proposed INN: Montelukast
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is assessing the efficacy of montelukast, a leukotriene receptor antagonist, in adults with mild to moderate persistent asthma. The pharmacological response will be defined as a reduction of  33% of exhaled nitric oxide concentrations over baseline values and/or increase of  15% in pre-bronchodilator FEF25%-75% over baseline values. FEV1, FVC, FEV1/FVC, PEF, FEF25%-75%, MEF75%, MEF50%, MEF25% will also be measured.;Secondary Objective: FEV1, FVC, FEV1/FVC, PEF, FEF25%-75%, MEF75%, MEF50%, MEF25%; association between CysLT1 and CysLT2 receptor gene polymorphisms and response to montelukast.;Primary end point(s): Concentrations of exhaled nitric oxide and FEF25%-75% values; assessing a possible association between LTC4 synthase gene polymorphisms and response to montelukast defined as The pharmacological response will be defined as a reduction of  33% of exhaled nitric oxide concentrations over baseline values and/or increase of  15% in pre-bronchodilator FEF25%-75% over baseline values | — |
Countries
Italy
Outcome results
None listed