Asthma MedDRA version: 8.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: ASMANEX TWISTHALER
Product Name: Mometasone Furoate Dry Powder Inhaler (MF DPI)
Product Code: SCH 32088
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Mometasone
CAS Number: 8
Sponsors
Schering-Plough Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subject must be female between 18 to 40 years of age, or male between 18 to 50 years of age, of any race. The subject must have at least a 3-month history of asthma. The subject must have never been treated with an ICS for control of their asthma, or not have taken ICS for at least 3 months immediately prior to Screening (Visit 1). The subject must have a prebronchodilator FEV1 >=60% and =12%, with an absolute volume increase of at least 200 mL, after reversibility testing. Prior to Visit 2, the subject must have a 25-hydroxy vitamin D level >=15 ng/mL. If the level is below 15 ng/mL, the subject may be retested after taking calcium plus vitamin D supplements for 4 weeks. In addition to the study-supplied calcium plus vitamin D supplement, at the invetsigator's discretion, an additional vitamin D supplement may be given during screening prior to the vitamin D retest. Vitamin D levels should be repeated prior to randomization and should meet the predefined level as stated above. The subject must be free of any clinically significant disease (other than asthma), or conditions known to affect bone mineral metabolism including renal disease, unstable hyperthyroidism or other endocrinopathies, Paget's disease, osteoporosis, malabsorption, or other systemic metabolic diseases or conditions that could interfere with study evaluations (eg, clinically relevant scoliosis, metal pins, clinically significant calcification in the spine and/or femur). The subject must have two valid scans, as confirmed by the local DXA center, for lumbar spine, left total femur, and femoral neck prior to randomization. For the purposes of this protocol, valid scans will be defined as 1) two scans of the same region, performed on the same day, that agree within 5% and 2) the scans are technically satisfactory (eg, correct scan mode, no artifacts present, correct region, etc). Are the trial subjects under 18? no 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The average of the two lumbar spine (L1-L4) scans at Screening is more than 2 standard deviations (SD) below young normal. Immobility is a risk factor for BMD loss, therefore, any condition present at Baseline that might significantly affect the subject's ability to ambulate normally, such as major surgical procedures, would exclude the subject from the study. In addition, any condition that may interfere with the BMD measurement will exclude the subject from the study. The subject has a history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder, which in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study. Specific examples include calcium urolithiasis or absorptive hypercalcuria, insulin-dependant diabetes, cancer within the last 10 years (except for basal cell carcinoma), active hepatitis, coronary artery disease, stroke, rheumatoid arthritis, HIV, OR conditions that may interfere with respiratory function such as clinically diagnosed COPD, chronic bronchitis, cystic fibrosis, etc. Other conditions which are well-controlled and stable (eg, hypertension, arrhythmia, subjects on stable thyroid hormone replacement for at least 3 months whose TSH levels are within normal range) may be allowed if deemed appropriate per the investigator's judgment. The subject has been treated within the last year with medication known to interfere with bone metabolism including: bisphosphonates (Fosamax®), estrogens such as depot injectables (estrogens used in oral combined hormonal contraceptives are allowed if the dose is maintained stable throughout the study), high-dose fluoride, and thyroid replacement hormones (if not stabilized). The subject has a history and/or presence of intraocular pressure in either eye >=22 mm Hg, glaucoma, and/or posterior subcapsular cataracts. The subject has undergone incisional or intraocular surgery in which the natural lens is still present in the eye. The subject has a history of penetrating trauma to both eyes. The subject has one or more of the following LOCS III grades at screening: - NO: >=3.0 - NC: >=3.0 - C: >=2.0 - P: >=0.5 A subject with a history and/or presence of a nuclear cataract or who has undergone bilateral lens extraction may be eligible for the study per the investigator's discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect on bone mineral density (BMD) of 1 year of treatment with mometasone furoate dry powder inhaler (MF DPI) 400 mcg QD PM to montelukast (ML) 10 mg QD PM, in adult subjects with asthma, who have never been treated with inhaled corticosteroids (ICS) or who have not been treated with ICS for at least 3 months immediately prior to Screening (Visit 1).;Secondary Objective: To evaluate the relative BMD effects of MF DPI 200 mcg QD PM, fluticasone propionate hydrofluoroalkane metered dose inhaler (FP HFA MDI) 250 mcg BID, and ML 10 mg QD PM.;Primary end point(s): The mean percent change in lumbar spine BMD from the averaged baseline value (the average of the two scan results prior to treatment) to the endpoint of treatment time point (the average of the last two valid post-baseline scan results during treatment) for the comparison of MF DPI 400 mcg QD PM vs ML 10 mg QD PM. Subjects who discontinued study treatment early will be followed throughout the full 1-year time period, however, these BMD scans performed while off study medication for these subjects will not be included in the primary endpoint analyses. | — |
Countries
Czech Republic, Denmark, Estonia, Lithuania
Outcome results
None listed