Status:
COMPLETED
A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241)
Lead Sponsor:
Organon and Co
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mo...
Detailed Description
Amendments 2 and 3 are specific to Brazil; all other countries will enroll patients under Amendment 1.
Eligibility Criteria
Inclusion
- Persistent asthma for at least 1-year
- Must use a daily asthma controller medication for at least 4 weeks prior to randomization, including an inhaled corticosteroid (ICS) with or without a long-acting beta agonist (LABA) or other adjunctive asthma therapy OR be using a leukotriene receptor antagonist (LTRA), xanthine or short acting beta agonist (SABA) as a monotherapy.
- Must be able to discontinue current asthma medication
- Must have a history of at least one asthma exacerbation in previous 4 to 52 weeks
Exclusion
- Unstable asthma
- Taking high dose ICS with or without other adjunctive therapy who have an Asthma Control Questionnaire 6 (ACQ6) total score ≥ 1.5
- Taking LTRA, xanthine or SABA monotherapy with an ACQ-6 total score \< 1.5 (controlled)
- Chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), or other significant, non-asthmatic, lung disease
- Clinically significant abnormality, illness or disorder of any body or organ system
- Significant underlying cardiovascular condition which may contraindicate use of a beta-agonist.
- History of smoking greater than 10-pack years
- Had an asthma exacerbation within 4 weeks of the Baseline Visit
- Had more than 4 asthma exacerbations or 2 hospitalizations within 52 weeks of the randomization visit
- Known or suspected hypersensitivity or intolerance to corticosteroids, beta-2 agonists, or any of the (inactive ingredients) excipients present in the medications used in this study
- Require the use of chronic systemic steroids, omalizumab, or other monoclonal or polyclonal antibodies
- Requires the use of beta-blockers
- History of life-threatening asthma, including an asthma episode that required intubation and/or was associated with hypercapnia requiring noninvasive ventilatory support
- Lactating, pregnant, or plans to become pregnant during the course of the trial
Key Trial Info
Start Date :
January 9 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2016
Estimated Enrollment :
11744 Patients enrolled
Trial Details
Trial ID
NCT01471340
Start Date
January 9 2012
End Date
November 30 2016
Last Update
May 23 2024
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