Safety and Effectiveness of MK 0476 in Patients chronic asthma
- Conditions
- Chronic asthmaTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-004776-27-Outside-EU/EEA
- Lead Sponsor
- Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 68
Patient is a female or male outpatient between 15 and 65 years of age.
Patient has a FEV1, while withholding short-acting ß2-agonist (SABA) for at least 6 hours, between 50% and 85% of predicted, documented at either Visits 1 or 2.
Patient has evidence of reversible airway obstruction, defined by an increase in FEV1 of =12%, compared with the pre-SABA baseline FEV1 (measured in liters), as assessed between 20 and 30 minutes after SABA administration and as documented at Visits 1 and 2.
Patient takes an inhaled SABA (e.g., albuterol) as needed for asthma, and has had no change in any asthma controller medication taken (including the dosage of asthma controller medication) within 4 weeks prior to Visit 1.
Patient is judged to be in stable health (except for asthma variability) on the basis of medical history, physical examination, and routine laboratory data, and appears able to successfully complete this trial.
Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 66
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patient is, in the opinion of the investigator, mentally or legally incapacitated preventing informed consent from being obtained, unable to read or comprehend written material, or unable to comply with the study procedures or protocol.
Patient is hospitalized or has been hospitalized in the 4 weeks prior to Visit 1.
Patient has undergone any major surgical procedure within 4 weeks prior to Visit 1.
Patient has been treated in an emergency room for asthma within 4 weeks of Visit 1 or has been hospitalized for asthma within 2 months prior to Visit 1.
Patient has had a respiratory tract infection which necessitated treatment with antibiotics within 2 months prior to Visit 1 or a respiratory tract infection which did not require treatment with antibiotics (e.g., viral) within 4 weeks prior to Visit 1.
Patient has taken any of the following anti-asthma medications or plans to take such medications during the study: Oral, intravenous, intramuscular, or rectal corticosteroids within 4 weeks prior to Visit 1; Leukotriene synthesis inhibitors within 7 days before Visit 1; Inhaled long- or short-acting anticholinergic agents within 7 days before Visit 1; Leukotriene receptor antagonists within 7 days before Visit 2; Inhaled long-acting ß2-agonist (LABA) or fixed-dose combination of inhaled corticosteroid (ICS) and LABA (e.g., fluticasone/salmeterol, ADVAIR ; or budesonide/formoterol, SYMBICORT ) within 7 days before Visit 2
Patient has taken any of the following medications prior to a study visit: Any SABA (such as albuterol) within 6 hours of a scheduled study visit; Any ICS within 1 hour of a scheduled study visit; Any medication containing an antihistamine within 48 hours of a scheduled study visit.
Patient has a history of hypersensitivity to aspirin and/or nonsteroidal anti-inflammatory medication.
Patient has used any medication with a narrow therapeutic index (e.g., warfarin, dicoumarol, digoxin, digitoxin) within 2 weeks prior to Visit 1 or plans to take such medications during the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that a single administration of inhaled montelukast, compared with placebo, provides rapid bronchodilation that varies by dose, as measured by improvement in FEV1 in patients aged 15 to 65 years with chronic asthma.<br>To determine the safety and tolerability of inhaled montelukast, compared<br>with placebo, in patients aged 15 to 65 years with chronic asthma.<br>;Secondary Objective: To demonstrate that albuterol provides additive bronchodilation when administered after inhaled montelukast in patients aged 15 to 65 years with chronic asthma.;Primary end point(s): Time weighted average change from baseline in FEV1 over first 4 hours;Timepoint(s) of evaluation of this end point: Time weighted average change from baseline in FEV1 over first 4 hours
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Onset of action FEV1(0-T min) with T = 10, 20, 30, 45, 60 min, 2 and 3 hours<br>Change from baseline in FEV1 at 8 and 24 hours<br>Average ?albuterol(post-base)FEV1 [0-T min] with T=15, 30, 60, and 90 min<br>- pooled montelukast doses<br>- montelukast mode dose<br>Average ?albuterol(post-pre)FEV1 [0- T min] with T=15, 30, 60, and 90 min<br>- montelukast mode dose<br>;Timepoint(s) of evaluation of this end point: Onset of action FEV1(0-T min) with T = 10, 20, 30, 45, 60 min, 2 and 3 hours<br>Change from baseline in FEV1 at 8 and 24 hours<br>Average ?albuterol(post-base)FEV1 [0-T min] with T=15, 30, 60, and 90 min<br>- pooled montelukast doses<br>- montelukast mode dose<br>Average ?albuterol(post-pre)FEV1 [0- T min] with T=15, 30, 60, and 90 min<br>- montelukast mode dose<br>