AsthmaPhase 4NCT00835094
A Randomized Trial Assessing Once Daily Administration of Mometasone Furoate DPI in Asthmatics (Study P02177)
A Phase 4 study testing Mometasone furoate in people with Asthma, run by Organon and Co.
Trial summary
This will be an open-label, randomized, parallel-group comparison of mometasone furoate dry powder inhaler (MF-DPI) 400 mcg once daily administered in the morning vs. the evening for 12 weeks in subjects with asthma. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Mometasone furoate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2002to 1 Jul 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects (and their parent/guardian if the subject is <18) must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must be >=12 years of age (unless restricted to an older age by local ethical committees or national health authorities), of either gender and any race.
- Subjects must have had a history of asthma for >=6 months.
- If the subject is taking inhaled corticosteroids, the daily dose must be <= the upper limit defined below:
- budesonide <=800 mcg/day
- triamcinolone acetonide <=800 mcg/day
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- beclomethasone dipropionate <=1000 mcg/day
- fluticasone propionate <=500 mcg/day
- flunisolide <=1000 mcg/day
- Women of childbearing potential must have a negative urine (hCG) pregnancy test on the day of randomization (Baseline visit).
- Women of childbearing potential (includes women who are <1 year postmenopausal) must be using an acceptable method of birth control (eg, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (eg, hysterectomy or tubal ligation).
- Subjects must agree to inform their usual treating physician (if other than the study investigator) of their participation in this study.
Who cannot join
- Female subjects who are pregnant, breast-feeding, or are premenarcheal.
- Subjects who have required daily or alternate day oral corticosteroid treatment for more than a total of 14 days during the 6 months immediately prior to Visit 1, and/or subjects who have required a course of systemic corticosteroids within the previous month.
- Subjects who have had either an asthma exacerbation or a clinically relevant change in asthma medication within the last 4 weeks.
- Subjects who have been admitted to the hospital for asthma control within the previous 3 months or more than once within the previous 6 months.
- Subjects who have required ventilator support for respiratory failure secondary to their asthma within the last 5 years.
- Subjects who have used any investigational drug in the 30 days prior to Baseline, or subjects who have been treated with any investigational antibody for asthma in the 90 days prior to Baseline.
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- Subjects who are allergic or have had an idiosyncratic reaction to corticosteroids.
- Subjects with any clinically significant disorder of the cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or immunologic system, or respiratory disease other than asthma (eg, COPD), or any other disorder which may interfere with the study evaluations or affect subject safety.
- Subjects with a history of drug abuse, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study.
About this study
Official title: A Randomized Trial Assessing the Chronobiology of Once Daily Administration of Mometasone Furoate DPI in Patients With Asthma
This will be an open-label, randomized, parallel-group comparison of mometasone furoate dry powder inhaler (MF-DPI) 400 mcg once daily administered in the morning vs. the evening for 12 weeks in subjects with asthma.
- Conditions
- Asthma
- Being tested
- Mometasone furoate
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone furoateDevice
Also called Asmanex, SCH 32088
MF-DPI 400 mcg once daily in the morning for 12 weeks
Mometasone furoateDevice
Also called Asmanex, SCH 32088
MF-DPI 400 mcg once daily in the evening for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Morning | Experimental | Not described Receives: Device: Mometasone furoate |
| Evening | Experimental | Not described Receives: Device: Mometasone furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-treatment group comparisons (MF-DPI 400 mcg once daily in the morning compared to the evening) of daytime and nocturnal symptoms based on a 4 point scale.
Measured: 12 weeks
To compare the incidence of adverse events of MF-DPI 400 mcg once daily administered in the morning compared to the evening.
Measured: 12 weeks
Secondary outcomes (2)
To assess morning vs. evening compliance with therapy.
Measured: 12 weeks
To assess subject satisfaction with the Twisthaler^TM device.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study start1 Oct 2002
- Primary completion1 Jul 2003
- Study completion1 Jul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 216 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
- NCT00835094
- Sponsor's protocol ID
- P02177
- Status last verified
- Feb 2022
- First submitted
- 30 Oct 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Assessing the Chronobiology of Once Daily Administration of Mometasone Furoate DPI in Patients With Asthma
- ClinicalTrials.gov ID
- NCT00835094
- Acronym / sponsor ID
- P02177
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2002 (actual)
- Primary completion
- 1 Jul 2003 (actual)
- Study completion
- 1 Jul 2003 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be an open-label, randomized, parallel-group comparison of mometasone furoate dry powder inhaler (MF-DPI) 400 mcg once daily administered in the morning vs. the evening for 12 weeks in subjects with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning | Experimental | Device: Mometasone furoate |
| Evening | Experimental | Device: Mometasone furoate |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects (and their parent/guardian if the subject is <18) must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must be >=12 years of age (unless restricted to an older age by local ethical committees or national health authorities), of either gender and any race.
- Subjects must have had a history of asthma for >=6 months.
- If the subject is taking inhaled corticosteroids, the daily dose must be <= the upper limit defined below:
- Women of childbearing potential must have a negative urine (hCG) pregnancy test on the day of randomization (Baseline visit).
Key exclusion criteria (9 listed)
- Female subjects who are pregnant, breast-feeding, or are premenarcheal.
- Subjects who have required daily or alternate day oral corticosteroid treatment for more than a total of 14 days during the 6 months immediately prior to Visit 1, and/or subjects who have required a course of systemic corticosteroids within the previous month.
- Subjects who have had either an asthma exacerbation or a clinically relevant change in asthma medication within the last 4 weeks.
- Subjects who have been admitted to the hospital for asthma control within the previous 3 months or more than once within the previous 6 months.
- Subjects who have required ventilator support for respiratory failure secondary to their asthma within the last 5 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 furoateAlso: Asmanex, SCH 32088MF-DPI 400 mcg once daily in the morning for 12 weeks | Device | Morning |
| Mometasone furoateAlso: Asmanex, SCH 32088MF-DPI 400 mcg once daily in the evening for 12 weeks | Device | Evening |
Primary outcome
Between-treatment group comparisons (MF-DPI 400 mcg once daily in the morning compared to the evening) of daytime and nocturnal symptoms based on a 4 point scale.
Time frame: 12 weeks
To compare the incidence of adverse events of MF-DPI 400 mcg once daily administered in the morning compared to the evening.
Time frame: 12 weeks
2 secondary outcomes
To assess morning vs. evening compliance with therapy.
Time frame: 12 weeks
To assess subject satisfaction with the Twisthaler^TM device.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
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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 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 9 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 15 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Between-treatment group comparisons (MF-DPI 400 mcg once daily in the morning compared to the evening) of daytime and nocturnal symptoms based on a 4 point scale. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2024.