Phase 3
Completed N=49
Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)
Source: ClinicalTrials.gov NCT01566149 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Number of Participants With At Least One Adverse Event (AE) — 5; 8 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With At Least One Adverse Event (AE) |
5; 8 | — |
| PRIMARY Number of Participants With At Least One Drug-Related AE |
0; 0 | — |
| PRIMARY Number of Participants With At Least One Serious AE |
0; 0 | — |
| PRIMARY Number of Participants Who Discontinued From the Study Due to an AE |
0; 1 | — |
| SECONDARY Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 |
2.397; 2.215; 2.503; 2.270; 0.106; 0.054 | — |
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
Data sourced from ClinicalTrials.gov (NCT01566149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.