E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
To determine the safety and tolerability of inhaled montelukast, compared
with placebo, in patients aged 15 to 65 years with chronic asthma.
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E.2.2 | Secondary objectives of the trial |
To demonstrate that albuterol provides additive bronchodilation when administered after inhaled montelukast in patients aged 15 to 65 years with chronic asthma. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient is a female or male outpatient between 15 and 65 years of age.
Patient has a FEV1, while withholding short-acting β2-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.
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E.4 | Principal exclusion criteria |
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 β2-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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Time weighted average change from baseline in FEV1 over first 4 hours |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Time weighted average change from baseline in FEV1 over first 4 hours |
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E.5.2 | Secondary end point(s) |
Onset of action FEV1(0-T min) with T = 10, 20, 30, 45, 60 min, 2 and 3 hours
Change from baseline in FEV1 at 8 and 24 hours
Average Δalbuterol(post-base)FEV1 [0-T min] with T=15, 30, 60, and 90 min
- pooled montelukast doses
- montelukast mode dose
Average Δalbuterol(post-pre)FEV1 [0- T min] with T=15, 30, 60, and 90 min
- montelukast mode dose
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E.5.2.1 | 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
Change from baseline in FEV1 at 8 and 24 hours
Average Δalbuterol(post-base)FEV1 [0-T min] with T=15, 30, 60, and 90 min
- pooled montelukast doses
- montelukast mode dose
Average Δalbuterol(post-pre)FEV1 [0- T min] with T=15, 30, 60, and 90 min
- montelukast mode dose
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |