AsthmaPhase 4NCT00394355
Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418)
A Phase 4 study testing mometasone furoate dry powder inhaler, fluticasone propionate hydrofluoroalkane (HFA) and montelukast in people with Asthma, run by Organon and Co.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- mometasone furoate dry powder inhaler, fluticasone propionate hydrofluoroalkane (HFA) and montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Oct 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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% \& <=90% predicted at both Screening \& Baseline, when all restricted medications withheld.
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- 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. Electrocardiogram (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, intra-uterine device (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 dual energy x-ray absorptiometry (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).
Who cannot join
- >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.
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- >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 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.
About this 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
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.
- Conditions
- Asthma
- Being tested
- mometasone furoate dry powder inhaler, fluticasone propionate hydrofluoroalkane (HFA), montelukast
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mometasone furoate dry powder inhalerDrug
Also called Asmanex
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.
mometasone furoate dry powder inhalerDrug
Also called Asmanex
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.
fluticasone propionate hydrofluoroalkane (HFA)Drug
Also called Flovent 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
montelukastDrug
Also called Singulair
10 mg given once daily in the evening by mouth for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | MF DPI 400 mcg once a day (QD) in the evening (PM) Receives: Drug: mometasone furoate dry powder inhaler |
| Group 2 | Experimental | MF DPI 200 mcg QD PM Receives: Drug: mometasone furoate dry powder inhaler |
| Group 3 | Active comparator | Fluticasone propionate (FP) metered dose inhaler (MDI) 250 mcg twice a day (BID) Receives: Drug: fluticasone propionate hydrofluoroalkane (HFA) |
| Group 4 | Active comparator | ML 10 mg QD PM Receives: Drug: montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point
The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.
Measured: Baseline and up to ~ one year of treatment
Secondary outcomes (3)
Mean Percent Change in the Left Total Femur From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point
The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.
Measured: Baseline and up to ~ one year of treatment
Mean Percent Change in the Femoral Neck BMD From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point
The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.
Measured: Baseline and up to ~ one year of treatment
Summary of Change From Baseline to Endpoint in FEV1 (Forced Expiratory Volume in One Second).
Mean percent change from Baseline (the last non-missing value prior to treatment) in pulmonary function test FEV1 from in-office visits and at Endpoint (last non-missing postbaseline value carried forward)
Measured: Baseline and up to ~ one year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startSep 2006
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394355
- Sponsor's protocol ID
- P03418
- Other IDs
- Doc ID: 3387777;, EUDRACT No: 2004-002930-21;
- Status last verified
- Feb 2022
- First submitted
- 31 Oct 2006
- Last updated
- 22 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Maspero J, Backer V, Yao R, Staudinger H, Teper A. Effects of mometasone, fluticasone, and montelukast on bone mineral density in adults with asthma. J Allergy Clin Immunol Pract. 2013 Nov-Dec;1(6):649-55.e1. doi: 10.1016/j.jaip.2013.07.011. Epub 2013 Oct 8.
PubMed 24565713
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00394355
- Acronym / sponsor ID
- P03418
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 1 Nov 2006 (estimated)
- Results
- Posted 7 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: mometasone furoate dry powder inhalerMF DPI 400 mcg once a day (QD) in the evening (PM) |
| Group 2 | Experimental | Drug: mometasone furoate dry powder inhalerMF DPI 200 mcg QD PM |
| Group 3 | Active comparator | Drug: fluticasone propionate hydrofluoroalkane (HFA)Fluticasone propionate (FP) metered dose inhaler (MDI) 250 mcg twice a day (BID) |
| Group 4 | Active comparator | Drug: montelukastML 10 mg QD PM |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (31 listed)
- >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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mometasone furoate dry powder inhalerAlso: Asmanex400 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. | Drug | Group 1 |
| mometasone furoate dry powder inhalerAlso: Asmanex200 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. | Drug | Group 2 |
| fluticasone propionate hydrofluoroalkane (HFA)Also: Flovent HFA250 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 | Drug | Group 3 |
| montelukastAlso: Singulair10 mg given once daily in the evening by mouth for 1 year. | Drug | Group 4 |
Primary outcome
Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point
Time frame: Baseline and up to ~ one year of treatment
The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.
3 secondary outcomes
Mean Percent Change in the Left Total Femur From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point
Time frame: Baseline and up to ~ one year of treatment
Mean Percent Change in the Femoral Neck BMD From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point
Time frame: Baseline and up to ~ one year of treatment
Summary of Change From Baseline to Endpoint in FEV1 (Forced Expiratory Volume in One Second).
Time frame: Baseline and up to ~ one year of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24565713Maspero J, Backer V, Yao R, Staudinger H, Teper A. Effects of mometasone, fluticasone, and montelukast on bone mineral density in adults with asthma. J Allergy Clin Immunol Pract. 2013 Nov-Dec;1(6):649-55.e1. doi: 10.1016/j.jaip.2013.07.011. Epub 2013 Oct 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mometasone furoate dry powder inhaler, fluticasone propionate hydrofluoroalkane (HFA) and montelukast in people with Asthma, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point (time frame: Baseline and up to ~ one year of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00394355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.