A 2-Week Double-Blind, Placebo-Controlled, Parallel Group Study Comparing the Anti- Inflammatory Effects of Low, Medium, and High Dose Mometasone Furoate/Formoterol Fumarate MDI Formulation and Medium Dose Mometasone Furoate DPI and MDI Formulations in Adults and Adolescents With Persistent Allergic Asthma.
- Conditions
- Persistent Allergic AsthmaMedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2007-001959-19-SE
- Lead Sponsor
- Schering-Plough Research Institute, a Division of Schering Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
1. To document a diagnosis of asthma, historical reversibility defined as an increase in absolute FEV1 of =12% and =200 mL must have been performed within 12 months of Screening. For subjects without historical reversibility, one of the following methods can be used at the Screening Visit, or at anytime prior to the Baseline Visit:
a. The subject must demonstrate an increase in absolute FEV1 of at least 12% and a volume increase of at least 200 mL within 15 to 20 minutes after administration of 4 inhalations of albuterol/salbutamol (total dose of 360 to 400 mcg) or of nebulized SABA (2.5 mg), if confirmed as standard office practice, OR
b. The subject must demonstrate a peak expiratory flow (PEF) variability of more than 20% expressed as a percentage of the mean highest and lowest morning prebronchodilator PEF over at least 1 week, OR
c. The subject must demonstrate a diurnal variation PEF of more than 20% based on the difference between the prebronchodilator (before taking albuterol/salbutamol) morning value and the postbronchodilator value (after taking albuterol/salbutamol) from the evening before, expressed as a percentage of the mean daily PEF value on any day during the open-label Run-in Period. {The calculation formula: Diurnal PEF Variation = Absolute [(highest of 3 readings, PM Post-BD PEF from prior evening) - (highest of 3 readings, AM Pre-BD from morning value)]/[(highest PM Post-BD + highest AM Pre-BD)/2] * 100}
2. At the Screening and Baseline Visits, a subject must have persistent allergic asthma with an FEV1 >65% predicted.
3. A subject must be allergic to at least one common allergen (grasses, trees, weeds, house dust mites, molds, dog and cat) as demonstrated by clinical symptoms when exposed to the allergen(s), and by skin prick testing or a RAST class >1 (excluding mRAST) within 2 years of inclusion in the study.
4. If, based upon the medical judgment of the investigator, there is no inherent harm in changing the subject’s current asthma therapy, the subject (and/or parent/guardian) must agree to discontinue prescribed ICS, anticholinergics, leukotriene receptor inhibitors, and long-acting ß2 agonists at the Screening Visit as per required washouts, and be transferred to treatment with SABA for relief for 2 weeks prior to the Baseline/Randomization Visit.
5. Clinical laboratory tests (complete blood count, blood chemistries, and urinalysis) conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator.
6. An electrocardiogram (ECG) performed at the Screening Visit or within 30 days prior to Screening Visit must be clinically acceptable to the investigator and have a QTc interval <440 msec for males and <450 msec for females.
7. At Screening or any time prior to Baseline, a subject must have an eNO level of >30 ppb at a flow rate of 50 mL/second.
8. At Screening or any time prior to Baseline, a subject must have a sputum eosinophil count >3% of total cell count.
9. A subject (and/or parent/guardian) must be willing to give written informed consent and able to adhere to dose and visit schedules. A subject 12 to 17 years of age must also provide written assent. In countries where local or national regulations only permit adult subjects to participate in clinical studies, adolescents, as defined by that country, will not be enrolled.
10. A nonpregnant female subject of childbearing potential must be using a medically acceptable, adequate form of birth control.
1. A subject who has been on systemic glucocorticosteroids (intravenous, intra-articular, or intramuscular), oral or high potency topical steroids within 3 months prior to Screening.
2. A subject who has had an upper or lower respiratory tract infection within the 4 weeks prior to Screening.
3. A subject who demonstrates a decrease in absolute FEV1 of >20% at any time between the Screening and Baseline Visits.
4. A subject who requires the use of greater than eight inhalations per day of SABA MDI, or two or more nebulized treatments of 2.5 mg SABA, on any 2 consecutive days between the Screening and Baseline Visits.
5. A subject who experiences a decrease in AM or PM PEF below the Run-in Period stability limit on any 2 consecutive days prior to Baseline. At Visit 1, the Run-in Period stability limit for PEF will be established based on the subject's personal best. If the subject does not have a historical personal best, the historical PEF measurement will be the PEF predicted based on the subject's sex, age, and height. PEF value will then be multiplied by 0.70 to determine the stability limit.
6. A subject who experiences a clinical asthma exacerbation defined as a clinical deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids but allowing SABA), as judged by the clinical investigator, between the Screening and Baseline Visits.
7. A subject who is unable to perform sputum induction after a maximum of two attempts.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To characterize the dose response of mometasone furoate/formoterol fumarate (MF/F) using exhaled nitric oxide (eNO) as a surrogate of airway inflammation.;Secondary Objective: To determine the effects of MF/F on asthma symptoms, peak expiratory flow (PEF), sputum eosinophil count and bronchial response to mannitol challenge.;Primary end point(s): The primary endpoint is the percent change from Baseline to Day 14 in eNO.
- Secondary Outcome Measures
Name Time Method