Clinical trial NCT01566149: Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)
Official title: An Open-Label Study to Assess the Safety and Tolerability of Zenhale® (a Fixed-Dose Combination of Mometasone Furoate/Formoterol Fumarate Delivered by Metered Dose Inhaler) in 40 Subjects With Persistent Asthma (Protocol No. 206-00 [P08212])
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2012-03-29
Enrollment: 49
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability \& effectiveness of 2 strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the treatment of persistent asthma in adults \& adolescents.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma of at least 6 months duration
* Current use of a medium or high daily dose of an inhaled corticosteroid (ICS) (alone or in combination with a long-acting beta agonist \[LABA\]) for at least 6 weeks prior to Screening AND must be on a stable asthma regimen (daily dose unchanged) for at least 2 weeks prior to Screening
* Agrees to change asthma therapy (if changing asthma therapy poses no inherent risk)
* If female of reproductive potential, agrees to remain abstinent or use 2 acceptable methods of birth control during study participation. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy, hormonal contraceptive

Exclusion Criteria:

* Treatment in the emergency room (for a severe asthma exacerbation), or admitted to the hospital for management of airway obstruction within previous 3 months
* Any prior ventilator support for respiratory failure secondary to asthma,
* Upper or lower respiratory tract infection (viral or bacterial) within previous 2 weeks
* History of a medical condition that, in the investigator's opinion, may interfere with study participation,
* History of smoking within previous year or a cumulative smoking history of more than 10 pack-years
* Known allergy to or intolerance of ICSs, LABAs, or any of the ingredients included in the study medications
* History of use of illicit drugs
* Inability to correctly use an oral MDI
* Pregnant, breastfeeding or plans to become pregnant during study

Primary outcomes:
measure: Number of Participants With At Least One Adverse Event (AE)
timeFrame: Up to Week 14
measure: Number of Participants With At Least One Drug-Related AE
timeFrame: Up to Week 14
measure: Number of Participants With At Least One Serious AE
timeFrame: Up to Week 14
measure: Number of Participants Who Discontinued From the Study Due to an AE
timeFrame: Up to Week 12
Secondary outcomes:
measure: Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
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