Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Formoterol Fumarate; Mometasone Furoate; Mometasone Furoate, Formoterol Fumarate Drug Combination

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