AsthmaPhase 3NCT01026870
Efficacy and Safety of Mometasone Furoate for Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids (ICS) (Study P06115)
A Phase 3 study testing SCH 32088 mometasone furoate (MF) metered-dose inhaler in people with Asthma, run by Organon and Co.
Trial summary
Mometasone furoate (MF) is a synthetic glucocorticosteroid that, when administered to asthma patients with a dry powder inhaler (Asmanex® Twisthaler®) at dosages of 100 to 400 mcg twice daily, has been shown to improve lung function, reduce symptoms of asthma, and reduce frequency and severity of exacerbations by… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- SCH 32088 mometasone furoate (MF) metered-dose inhaler
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Dec 2013
- Phase
- Phase 3
- 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
- An adult or adolescent subject with a diagnosis of persistent asthma of >=6 months duration may be selected for this study.
- Both subject (and/or parent/guardian, if appropriate) and investigator must agree that changing therapy is acceptable and poses no inherent risk.
- Subject must have been using a low daily maintenance dose of inhaled corticosteroids (ICS), with or without added long-acting β2-agonist (LABA), for >=12 weeks prior to Screening, and must have been on a stable regimen (daily dose unchanged) for at least the last 2 weeks of that period.
- At Screening, the subject must have a prebronchodilator FEV1 between 60% and 90% of the predicted value when restricted medications have been withheld.
- To be randomized, the subjects must be symptomatic with FEV1 at Baseline must be between 50% and 85% of predicted.
Who cannot join
- A subject must not have been admitted to the hospital for management of airway obstruction within the last 3 months prior to Screening, and must not have experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication, as judged by the clinical investigator at any time from Screening to Baseline/Randomization.
- In addition, a subject must not have demonstrated a decrease in absolute FEV1 of >20% at any time from Screening to Baseline, or a decrease in AM peak expiratory flow (PEF) below the PEF stability limit on any 2 consecutive days prior to Baseline/Randomization.
About this study
Official title: A 12-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate Monotherapy in Subjects With Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids
Mometasone furoate (MF) is a synthetic glucocorticosteroid that, when administered to asthma patients with a dry powder inhaler (Asmanex® Twisthaler®) at dosages of 100 to 400 mcg twice daily, has been shown to improve lung function, reduce symptoms of asthma, and reduce frequency and severity of exacerbations by reducing airway inflammation, with a relatively low potential to cause systemic side effects such as hypothalamic-pituitary-adrenal (HPA) axis suppression.
An experimental formulation of MF 100 mcg delivered twice daily via a pressurized metered-dose inhaler (MDI) also has been shown to be effective in improving lung function of asthma patients as measured by forced expiratory volume in 1 second (FEV1). This trial is designed to verify the effectiveness of twice daily MF MDI 100 mcg in treating asthma in adults and adolescents previously treated with low dosages of inhaled corticosteroids (ICS), as measured by improvement in morning FEV1 and time to first asthma exacerbation over 12 weeks of treatment.
- Conditions
- Asthma
- Being tested
- SCH 32088 mometasone furoate (MF) metered-dose inhaler, Placebo metered-dose inhaler BID
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 32088 mometasone furoate (MF) metered-dose inhalerDrug
Also called SCH 032088
2 inhalations from a MF 50 mcg inhaler each morning and evening, approximately 12 hours apart, for 12 weeks.
Placebo metered-dose inhaler BIDDrug
2 inhalations from a placebo metered-dose inhaler each morning and evening, approximately 12 hours apart, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mometasone furoate (MF) metered-dose inhaler 100 mcg BID | Active comparator | 2 inhalations from a MF 50 mcg inhaler each morning and evening, approximately 12 hours apart, for 12 weeks Receives: Drug: SCH 32088 mometasone furoate (MF) metered-dose inhaler |
| Placebo metered-dose inhaler BID | Placebo comparator | 2 inhalations from a matching placebo inhaler each morning and evening, approximately 12 hours apart, for 12 weeks. Receives: Drug: Placebo metered-dose inhaler BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Endpoint in the morning (AM trough) forced expiratory volume in 1 second (FEV1)
Measured: Endpoint: last non-missing post-Baseline observation carried forward over 12 weeks of treatment
Secondary outcomes (1)
Time to first severe asthma exacerbation during the 12 week Treatment Period
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 posted7 Dec 2009 (estimated)
- Study startJun 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT01026870
- Sponsor's protocol ID
- P06115
- Status last verified
- Feb 2022
- First submitted
- 4 Dec 2009
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate Monotherapy in Subjects With Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids
- ClinicalTrials.gov ID
- NCT01026870
- Acronym / sponsor ID
- P06115
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 7 Dec 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.
Mometasone furoate (MF) is a synthetic glucocorticosteroid that, when administered to asthma patients with a dry powder inhaler (Asmanex® Twisthaler®) at dosages of 100 to 400 mcg twice daily, has been shown to improve lung function, reduce symptoms of asthma, and reduce frequency and severity of exacerbations by reducing airway inflammation, with a relatively low potential to cause systemic side effects such as hypothalamic-pituitary-adrenal (HPA) axis suppression.
An experimental formulation of MF 100 mcg delivered twice daily via a pressurized metered-dose inhaler (MDI) also has been shown to be effective in improving lung function of asthma patients as measured by forced expiratory volume in 1 second (FEV1). This trial is designed to verify the effectiveness of twice daily MF MDI 100 mcg in treating asthma in adults and adolescents previously treated with low dosages of inhaled corticosteroids (ICS), as measured by improvement in morning FEV1 and time to first asthma exacerbation over 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mometasone furoate (MF) metered-dose inhaler 100 mcg BID | Active comparator | Drug: SCH 32088 mometasone furoate (MF) metered-dose inhaler2 inhalations from a MF 50 mcg inhaler each morning and evening, approximately 12 hours apart, for 12 weeks |
| Placebo metered-dose inhaler BID | Placebo comparator | Drug: Placebo metered-dose inhaler BID2 inhalations from a matching placebo inhaler each morning and evening, approximately 12 hours apart, for 12 weeks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- An adult or adolescent subject with a diagnosis of persistent asthma of >=6 months duration may be selected for this study.
- Both subject (and/or parent/guardian, if appropriate) and investigator must agree that changing therapy is acceptable and poses no inherent risk.
- Subject must have been using a low daily maintenance dose of inhaled corticosteroids (ICS), with or without added long-acting β2-agonist (LABA), for >=12 weeks prior to Screening, and must have been on a stable regimen (daily dose unchanged) for at least the last 2 weeks of that period.
- At Screening, the subject must have a prebronchodilator FEV1 between 60% and 90% of the predicted value when restricted medications have been withheld.
- To be randomized, the subjects must be symptomatic with FEV1 at Baseline must be between 50% and 85% of predicted.
Key exclusion criteria (2 listed)
- A subject must not have been admitted to the hospital for management of airway obstruction within the last 3 months prior to Screening, and must not have experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication, as judged by the clinical investigator at any time from Screening to Baseline/Randomization.
- In addition, a subject must not have demonstrated a decrease in absolute FEV1 of >20% at any time from Screening to Baseline, or a decrease in AM peak expiratory flow (PEF) below the PEF stability limit on any 2 consecutive days prior to Baseline/Randomization.
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 |
|---|---|---|
| SCH 32088 mometasone furoate (MF) metered-dose inhalerAlso: SCH 0320882 inhalations from a MF 50 mcg inhaler each morning and evening, approximately 12 hours apart, for 12 weeks. | Drug | Mometasone furoate (MF) metered-dose inhaler 100 mcg BID |
| Placebo metered-dose inhaler BID2 inhalations from a placebo metered-dose inhaler each morning and evening, approximately 12 hours apart, for 12 weeks. | Drug | Placebo metered-dose inhaler BID |
Primary outcome
Change from Baseline to Endpoint in the morning (AM trough) forced expiratory volume in 1 second (FEV1)
Time frame: Endpoint: last non-missing post-Baseline observation carried forward over 12 weeks of treatment
1 secondary outcome
Time to first severe asthma exacerbation during the 12 week Treatment Period
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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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 3 study testing SCH 32088 mometasone furoate (MF) metered-dose 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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 16 Feb 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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 to Endpoint in the morning (AM trough) forced expiratory volume in 1 second (FEV1) (time frame: Endpoint: last non-missing post-Baseline observation carried forward over 12 weeks of treatment). 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 16 Feb 2022.