Efficacy and Safety of Mometasone Furoate for Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids (ICS) (Study P06115)
This study has been withdrawn prior to enrollment.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT01026870
First received: December 4, 2009
Last updated: January 27, 2011
Last verified: January 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: SCH 32088 mometasone furoate (MF) metered-dose inhaler Drug: Placebo metered-dose inhaler BID |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to first severe asthma exacerbation during the 12 week Treatment Period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 430 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Mometasone furoate (MF) metered-dose inhaler 100 mcg BID
2 inhalations from a MF 50 mcg inhaler each morning and evening, approximately 12 hours apart, for 12 weeks
|
Drug: SCH 32088 mometasone furoate (MF) metered-dose inhaler
2 inhalations from a MF 50 mcg inhaler each morning and evening, approximately 12 hours apart, for 12 weeks.
Other Name: SCH 032088
|
|
Placebo Comparator: Placebo metered-dose inhaler BID
2 inhalations from a matching placebo inhaler each morning and evening, approximately 12 hours apart, for 12 weeks.
|
Drug: Placebo metered-dose inhaler BID
2 inhalations from a placebo metered-dose inhaler each morning and evening, approximately 12 hours apart, for 12 weeks.
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Vice President of Late Stage Development, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT01026870 History of Changes |
| Other Study ID Numbers: | P06115 |
| Study First Received: | December 4, 2009 |
| Last Updated: | January 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Mometasone furoate Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013