Study 20 of 347 for search of: Peru
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418AM4)
This study is ongoing, but not recruiting participants.
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00394355
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: mometasone furoate dry powder inhaler
Drug: fluticasone propionate HFA
Drug: montelukast
Phase IV

MedlinePlus related topics: Asthma Minerals Nuclear Scans
Drug Information available for: Fluticasone Fluticasone propionate Mometasone furoate Montelukast sodium Montelukast
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study
Official Title: 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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Mean % change in lumbar spine BMD from the averaged baseline value (average of two scan results prior to treatment) to the endpoint of treatment time point, ie, average of last two valid post Baseline BMD scans during treatment period carried forward [ Time Frame: one year of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean percent change in the left total femur and femoral neck BMD from the averaged baseline value to the averaged value at the endpoint of treatment time point. [ Time Frame: one year of treatment ] [ Designated as safety issue: Yes ]
  • All BMD assessments. [ Time Frame: At 26 weeks and 52 weeks. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 560
Study Start Date: September 2006
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1: Experimental
MF DPI 400 mcg QD PM
Drug: mometasone furoate dry powder inhaler
400 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year.
Group 2: Experimental
MF DPI 200 mcg QD PM
Drug: mometasone furoate dry powder inhaler
200 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year.
Group 3: Active Comparator
FP MDI 250 mcg BID
Drug: fluticasone propionate HFA
250 mcg FP HFA given twice a day via a metered-dose inhaler and a placebo tablet given once daily in the evening for 1 year
Group 4: Active Comparator
ML 10 mg QD PM
Drug: montelukast
10 mg given once daily in the evening by mouth for 1 year.
Group 5: Active Comparator
ML 10 mg QD PM; having a second montelukast arm allows for double-blind conditions by inhaler.
Drug: montelukast
10 mg given once daily in the evening by mouth for 1 year; having a second montelukast arm allows for double-blind conditions by inhaler.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent, adhere to schedules.
  • Inform usual treating MD of study participation.
  • Female 18 to 40, male 18 to 50, any race.
  • >=3-month asthma history.
  • Never treated with ICS for asthma or not have taken ICS for ≥3 months prior to Screening.
  • Prebronchodilator FEV1 >=60% & <=90% predicted at both Screening & Baseline, when all restricted medications withheld.
  • Prior to randomization, demonstrate increase in absolute FEV1 of >=12%, with absolute volume increase of >=200 mL, after reversibility testing.
  • Lab tests normal/acceptable to investigator/sponsor. ECG performed at screening or <30 days of screening normal/acceptable to investigator. Chest x-ray performed at screening or <12 months of screening normal/acceptable to investigator.
  • 25-hydroxy vitamin D level >=15 ng/mL. If <15, re-tested after taking calcium plus vitamin D for 4 weeks.
  • Free of significant disease (other than asthma) known to affect bone mineral metabolism including renal disease, unstable hyperthyroidism or other endocrinopathies, Paget's disease, osteoporosis, malabsorption, or others that could interfere with study evaluations (eg scoliosis, metal pins, calcification in spine/femur).
  • Women of childbearing potential must use birth control. Includes: hormonal contraceptive, IUD; condom in combination with spermicide; monogamous relationship with male who had vasectomy or is using condom. Started method ≥3 months prior to Screening (exception condom), & agree to continue for duration. Women who are not currently sexually active must agree/consent to using double-barrier method if become active. Females must have negative serum pregnancy test at Screening.
  • 2 valid scans, as confirmed by local DXA center, for lumbar spine, left total femur, & femoral neck prior to randomization. Valid scans will be 2 scans of same region, performed on same day, that agree within 5% & scans are technically satisfactory (eg correct scan mode, no artifacts present, correct region).

Exclusion Criteria:

  • >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 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, HIV, or respiratory conditions such as 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 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 LOCS III grades at screening: NO >=3.0, NC >=3.0, C >=2.0, 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.
  • BMI >35 kg/m2.
  • HIV positive (testing not performed).
  • Alcoholic or illicit drug abuser.
  • Evidence of oropharyngeal candidiasis at Baseline with or without treatment. If evidence at Screening, may be treated as appropriate & visit can be scheduled upon resolution. If evidence at Baseline Visit, may be treated as appropriate & visit can be rescheduled upon resolution.
  • Normal sleep/wake cycle is inverted (eg night shift workers).
  • Taken restricted medications prior to Screening.
  • Cannot adhere to prohibited & permitted concomitant medications.
  • No subject may participate in this same study at another site or simultaneously in any other study.
  • No person directly associated with administration of study may participate.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394355

  Show 57 Study Locations
Sponsors and Collaborators
Schering-Plough
  More Information

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P03418, Doc ID: 3387777;, EUDRACT No: 2004-002930-21;
Study First Received: October 31, 2006
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00394355  
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study placed in the following topic categories:
Montelukast
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Mometasone furoate
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Asthma
Leukotriene Antagonists
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009