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

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI; Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT01566149

P08212

MK-0887A-206 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

MF/F 200/10 mcg MDI BID

Active Comparator group

Description:

Participants receiving MF/F 200/10 mcg MDI twice daily (BID) for 12 weeks

Treatment:

Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI

MF/F 400/10 mcg MDI BID

Active Comparator group

Description:

Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks

Treatment:

Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI