Comparative Study of the Effect of Two Doses of Mometasone Furoate Dry Powder Inhaler 200 mcg and 400 mcg QD PM, Fluticasone Propionate 250 mcg BID, and Montelukast 10 mg QD PM, on Bone Mineral Density in Adults With Asthma - N/A

• Conditions: Asthma; MedDRA version: 8.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2004-002930-21-EE
• Lead Sponsor: Schering-Plough Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 560

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 <=90% predicted at both Screening and Baseline, when all restricted medications have been withheld for the specified interval.

Prior to randomization, the subject must demonstrate an increase in absolute FEV1 of >=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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified