Phase 4
Completed N=566
Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418)
Source: ClinicalTrials.gov NCT00394355 ↗Enrolled (actual)
566
Serious AEs
3.4%
Results posted
Mar 2011
Primary outcomePrimary: Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point — 0.7; 0.9; 1.1; 1.2 percentage of BMD — p=0.261
Summary
This is a randomized, multi-center, parallel-group, active-controlled, double-blind study evaluating the effects of mometasone furoate (MF) dry powder inhaler (DPI) on bone mineral density (BMD) in subjects with asthma. 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 daily in the evening versus montelukast (ML) 10 mg daily in the evening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point |
0.7; 0.9; 1.1; 1.2 | 0.261 |
| SECONDARY Mean Percent Change in the Left Total Femur From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point |
0.3; 0.2; 0.2; 0.5 | 0.359 |
| SECONDARY Mean Percent Change in the Femoral Neck BMD From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point |
-0.2; 0.4; -0.4; -0.2 | 0.169 |
| SECONDARY Summary of Change From Baseline to Endpoint in FEV1 (Forced Expiratory Volume in One Second). |
0.29; 0.38; 0.31; 0.19 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Informed consent, adhere to schedules.
- Inform usual treating medical doctor (MD) of study participation.
- Female 18 to 40, male 18 to 50, any race.
- >=3-month asthma history.
- Never treated with inhaled corticosteroids (ICS) for asthma or not have taken ICS for ≥3 months prior to Screening.
- Prebronchodilator forced expiratory volume (liters) in 1 second (FEV1) >=60% & =12%, with absolute volume increase of >=200 mL, after reversibility testing.
- Lab tests normal/acceptable to investigator/sponsor. Electrocardiogram (ECG) performed at screening or =15 ng/mL. If 12 inhalations/day of salbutamol on 2 consecutive days between Screening & Baseline.
- Increase/decrease in FEV1 of >=20% between Screening & Baseline.
- Treated with methotrexate, cyclosporin, gold, or other cytotoxic agents, for asthma or concurrent condition within last 3 months.
- Pipe/cigar smoking history.
- Smoker/ex-smoker who smoked within previous year or has smoking history ≥10 pack-years.
- Upper/lower respiratory tract infection within 2 weeks prior to Screening & Baseline. Can be rescheduled.
- >14 days of oral steroids within previous 12 months or required burst of systemic steroids within previous month.
- Ever required ventilator support for respiratory failure secondary to asthma.
- Treated in emergency room (ER) for asthma exacerbation or admitted to hospital for management of airway obstruction on 1 occasion in last 3 months or on >=2 occasions within last 6 months.
- Chronic bronchitis, bronchiectasis, emphysema or cystic fibrosis.
- Participated in study within last 30 days.
- Allergic to/intolerant of ICS, beta-agonists, or drugs/excipients in study.
- Average of 2 lumbar spine (L1-L4) scans at Screening is >2 standard deviations below normal.
- Condition that might affect ability to ambulate normally, (ie major surgical procedure). Condition that may interfere with BMD measurement.
- History of renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, respiratory, gastrointestinal, cerebrovascular, or other which could interfere with study or require treatment which might interfere (eg calcium urolithiasis or absorptive hypercalcuria, insulin dependent diabetes, cancer within last 10 years (except basal cell carcinoma), active hepatitis, coronary artery disease, stroke, rheumatoid arthritis, human immunodeficiency virus (HIV), or respiratory conditions such as chronic obstructive pulmonary disease (COPD), chronic bronchitis, cystic fibrosis. Others which are well-controlled & stable (eg hypertension, arrhythmia, subjects on stable thyroid hormone replacement for at least 3 months whose thyroid stimulating hormone (TSH) levels are normal) may be allowed.
- Treated within last year with drug known to interfere with bone metabolism including: bisphosphonates, estrogens such as depot injectables (estrogens used in oral combined hormonal contraceptives are allowed if dose is stable throughout), high-dose fluoride, & thyroid replacement hormones (if not stabilized).
- History &/or presence of intraocular pressure in either eye >=22 mm Hg, glaucoma, &/or posterior subcapsular cataracts. History &/or presence of nuclear cataract or undergone bilateral lens extraction may be eligible.
- 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 lens opacities classification system version III (LOCS III) grades at screening: nuclear opalescence (NO) >=3.0, nuclear color (NC) >=3.0, cortical (C) >=2.0, posterior (P) >=0.5.
- Pregnant, breast-feeding, or postmenopausal women. Amenorrhea >6 months will be excluded (exception hysterectomy). Bilateral oophorectomy excluded.
- Relevant abnormal Baseline vital sign.
- Body mass index (BMI) >35 kg/m2.
- HIV positive (testing not performed).
- Alcoholic or illicit drug abuser.
- Evidence of oropharyngeal candidi
Data sourced from ClinicalTrials.gov (NCT00394355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.