AsthmaPhase 4NCT00521599
A Study of the Equivalent Effectiveness of 400 mcg Mometasone Furoate Using Two Different Dry Powder Inhalers in Moderate Asthmatics (Study P04828)
A Phase 4 study testing Mometasone furoate dry powder inhaler in people with Asthma, run by Organon and Co.
Trial summary
This study is a placebo-controlled study with 8-weeks of double-blind treatment of mometasone furoate dry powder inhaler (MF DPI) 200 mcg twice daily (BID) using two different inhalers, preceded by the Screening Period and by 2 weeks of open-label treatment with one inhalation of MF DPI 200 mcg twice daily in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Mometasone furoate dry powder inhaler
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 672 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age, either sex, any race, with a diagnosis of asthma of at least 12 months' duration.
- Must be on a stable regimen of a medium daily dose of ICS for at least 4 weeks immediately prior to Screening. Medium daily doses of ICS are:
- >500 to 1000 mcg beclomethasone CFC
- >250 to 500 mcg beclomethasone HFA
- >600 to 1000 mcg budesonide DPI
- >1000 to 2000 mcg flunisolide
Show all 16Show fewer
- >250 to 500 mcg fluticasone
- 400 mcg MF
- >1000 to 2000 mcg triamcinolone acetonide.
- Must have a documented reversibility test obtained within 12 months prior to signing the informed consent form. Otherwise, to document a diagnosis of asthma and ensure the subject's responsiveness to bronchodilators, one of the following methods can be used at the Screening Visit, or thereafter, but prior to the Baseline Visit:
- An increase in absolute FEV1 of >=12% and >=200 mL within 30 minutes of administration of 4 puffs of albuterol.
- A PEF variability of >20%, expressed as a percent of the best and lowest morning pre-bronchodilator PEF over at least 1 week.
- A diurnal variation in PEF of >20% based on the difference between the pre-bronchodilator AM value and the post-bronchodilator value from the evening before, expressed as a percentage of the mean daily PEF value any day during the Run-in Period.
- At Screening and Baseline, the subject's FEV1 must be >=60% predicted, when all restricted medications have been withheld for the appropriate intervals. If, based on the clinical judgment of the investigator, there is no harm in changing the subject's asthma therapy, subjects on LABAs must be willing to discontinue the LABA and be transferred to open-label treatment with MF MDI 200 mcg BID for 2 weeks prior to randomization.
- Clinical laboratory tests conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor before the subject is instructed to start using open-label MF DPI run-in medication. A chest x-ray performed at the Screening Visit or any type of chest imaging within 12 months prior to the Screening Visit must be clinically acceptable to the investigator.
- A female of childbearing potential must be using a medically acceptable, adequate form of birth control. This includes: 1) hormonal contraceptives as prescribed by a physician (oral combined, hormonal implant); 2) medically prescribed IUD; 3) condom in combination with a spermicide (double-barrier method); 4) monogamous relationship with a male partner who has had a vasectomy. The subject must have started this birth control method at least 3 months prior to Screening (with the exception of condom in combination with spermicide), and must agree to continue its use for the duration of the study. A subject of childbearing potential who is not currently sexually active must agree and consent to using a medically acceptable method should she become sexually active during the course of this study. Women who have been surgically sterilized or are at least 1 year postmenopausal are not considered to be of childbearing potential. A subject of childbearing potential must have a negative serum pregnancy test at Screening.
Who cannot join
- A change in absolute FEV1 of >20% at any time from the Screening Visit up to and including the Baseline Visit.
- A clinical asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization, or treatment with additional, excluded asthma medication at any time from the Screening Visit up to and including the Baseline Visit).
- Treatment in the emergency department or admission to the hospital for an asthma exacerbation 12 months prior to Screening.
- An upper or lower respiratory tract infection within the 4 weeks of to Screening. Visits can be rescheduled to meet this requirement.
- Evidence of clinically significant oropharyngeal candidiasis at Baseline with or without treatment. If there is evidence of oropharyngeal candidiasis at Screening and/or during the MF DPI Run-in Period, the subject may be treated as appropriate and the Baseline Visit can be scheduled upon resolution. If there is evidence of oropharyngeal candidiasis at the Baseline Visit, the subject may be treated as appropriate and the visit can be rescheduled upon resolution.
- A smoker or ex-smoker and has smoked within the previous year or has had a cumulative smoking history >10 pack-years.
- Requires more than twelve inhalations of albuterol or more than 2 treatments with nebulized beta-agonists on any 2 consecutive days during the Run-in Period.
- Ever required mechanical ventilation secondary to an asthma exacerbation.
About this study
Official title: A Study of the Therapeutic Equivalency of MF DPI 100 mcg and 200 mcg Inhalers in Corticosteroid-Dependent Subjects With Moderate Asthma
This study is a placebo-controlled study with 8-weeks of double-blind treatment of mometasone furoate dry powder inhaler (MF DPI) 200 mcg twice daily (BID) using two different inhalers, preceded by the Screening Period and by 2 weeks of open-label treatment with one inhalation of MF DPI 200 mcg twice daily in corticosteroid-dependent asthmatic subjects. The objective of this study is to evaluate the therapeutic equivalency of the 100 mcg and 200 mcg MF DPIs when providing the same total daily dose (400 mcg/day).
- Conditions
- Asthma
- Being tested
- Mometasone furoate dry powder inhaler, Placebo
- 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| MF DPI 2 x 100 mcg BID | Experimental | 2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks Receives: Drug: Mometasone furoate dry powder inhaler; Drug: Placebo |
| MF DPI 1 x 200 mcg BID | Experimental | 1 inhalation of mometasone furoate dry powder inhaler (MF DPI) 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily (BID) for 8 weeks Receives: Drug: Mometasone furoate dry powder inhaler; Drug: Placebo |
| Placebo | Placebo comparator | 2 inhalations of placebo matching mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Average AM Peak Expiratory Flow (PEF) Over the 7 Days of Week 8.
Week 8 End = The last 7 days of data with the last day within the range of Days 51 to 64.
Measured: Baseline and Week 8 End
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionMar 2009
- Study completionMar 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.
- 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
- 672 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
- NCT00521599
- Sponsor's protocol ID
- P04828
- Status last verified
- Feb 2022
- First submitted
- 27 Aug 2007
- Last updated
- 23 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Therapeutic Equivalency of MF DPI 100 mcg and 200 mcg Inhalers in Corticosteroid-Dependent Subjects With Moderate Asthma
- ClinicalTrials.gov ID
- NCT00521599
- Acronym / sponsor ID
- P04828
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 672 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 28 Aug 2007 (estimated)
- Results
- Posted 23 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a placebo-controlled study with 8-weeks of double-blind treatment of mometasone furoate dry powder inhaler (MF DPI) 200 mcg twice daily (BID) using two different inhalers, preceded by the Screening Period and by 2 weeks of open-label treatment with one inhalation of MF DPI 200 mcg twice daily in corticosteroid-dependent asthmatic subjects. The objective of this study is to evaluate the therapeutic equivalency of the 100 mcg and 200 mcg MF DPIs when providing the same total daily dose (400 mcg/day).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MF DPI 2 x 100 mcg BID | Experimental | Drug: Mometasone furoate dry powder inhaler, Drug: Placebo2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks |
| MF DPI 1 x 200 mcg BID | Experimental | Drug: Mometasone furoate dry powder inhaler, Drug: Placebo1 inhalation of mometasone furoate dry powder inhaler (MF DPI) 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily (BID) for 8 weeks |
| Placebo | Placebo comparator | Drug: Placebo2 inhalations of placebo matching mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 18 years of age, either sex, any race, with a diagnosis of asthma of at least 12 months' duration.
- Must be on a stable regimen of a medium daily dose of ICS for at least 4 weeks immediately prior to Screening. Medium daily doses of ICS are:
- Must have a documented reversibility test obtained within 12 months prior to signing the informed consent form. Otherwise, to document a diagnosis of asthma and ensure the subject's responsiveness to bronchodilators, one of the following methods can be used at the Screening Visit, or thereafter, but prior to the Baseline Visit:
- At Screening and Baseline, the subject's FEV1 must be >=60% predicted, when all restricted medications have been withheld for the appropriate intervals. If, based on the clinical judgment of the investigator, there is no harm in changing the subject's asthma therapy, subjects on LABAs must be willing to discontinue the LABA and be transferred to open-label treatment with MF MDI 200 mcg BID for 2 weeks prior to randomization.
- Clinical laboratory tests conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor before the subject is instructed to start using open-label MF DPI run-in medication. A chest x-ray performed at the Screening Visit or any type of chest imaging within 12 months prior to the Screening Visit must be clinically acceptable to the investigator.
Key exclusion criteria (8 listed)
- A change in absolute FEV1 of >20% at any time from the Screening Visit up to and including the Baseline Visit.
- A clinical asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization, or treatment with additional, excluded asthma medication at any time from the Screening Visit up to and including the Baseline Visit).
- Treatment in the emergency department or admission to the hospital for an asthma exacerbation 12 months prior to Screening.
- An upper or lower respiratory tract infection within the 4 weeks of to Screening. Visits can be rescheduled to meet this requirement.
- Evidence of clinically significant oropharyngeal candidiasis at Baseline with or without treatment. If there is evidence of oropharyngeal candidiasis at Screening and/or during the MF DPI Run-in Period, the subject may be treated as appropriate and the Baseline Visit can be scheduled upon resolution. If there is evidence of oropharyngeal candidiasis at the Baseline Visit, the subject may be treated as appropriate and the visit can be rescheduled upon resolution.
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: Asmanex | Drug | MF DPI 1 x 200 mcg BID, MF DPI 2 x 100 mcg BID |
| Placebo | Drug | MF DPI 1 x 200 mcg BID, MF DPI 2 x 100 mcg BID, Placebo |
Primary outcome
Change From Baseline in the Average AM Peak Expiratory Flow (PEF) Over the 7 Days of Week 8.
Time frame: Baseline and Week 8 End
Week 8 End = The last 7 days of data with the last day within the range of Days 51 to 64.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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 16 inclusion and 8 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 23 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. Some participants in this study may receive a placebo. 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 23 Mar 2010). 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?
Change From Baseline in the Average AM Peak Expiratory Flow (PEF) Over the 7 Days of Week 8. (time frame: Baseline and Week 8 End). 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 23 May 2024.