Phase 3
Completed N=272
A Patient Handling Study of Mometasone Furoate/Formortoral Fumarate (MF/F) Metered Dose Inhaler (MDI) With an Integrated Dose Counter in Adolescent and Adult Subjects With Asthma or Chronic Obstructive Pulmonary Disease (Study P04703AM1)
Source: ClinicalTrials.gov NCT00604500 ↗Enrolled (actual)
272
Serious AEs
0.4%
Results posted
Apr 2011
Primary outcomePrimary: Overall Discrepancy Rate — 0.13 Overall discrepancies per 100 actuations
Summary
This was an open-label, multiple-dose, study of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 micrograms (mcg) twice daily (BID) (2 puffs of MF/F MDI 50/5 mcg, administered twice a day approximately 12 hours apart) in participants 12 years of age or older, with a diagnosis of persistent asthma or chronic obstructive pulmonary disease (COPD) of at least 12 months. The primary purpose of the study was to evaluate the performance of the MF/F MDI integrated dose counter under normal patient handling conditions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Discrepancy Rate |
0.13 | — |
| PRIMARY Overall Quartile Discrepancy Rate |
0.13 | — |
| PRIMARY Overall Discrepancy Size |
0.14 | — |
| PRIMARY End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population) |
175 | — |
Eligibility Criteria
Diagnosis and Criteria for Inclusion:
- A participant must have been at least 12 years of age, of either sex, and of any race, with a diagnosis of persistent asthma or COPD of at least 12 months.
- A participant must have been able to demonstrate correct use of an MDI without a counter at the Screening Visit.
- A participant must have demonstrated at least 90% compliance with completion of the e-diary, use of the counterstrip, and use of the study medication over the 2-week Screening Period.
Exclusion Criteria
- Participants with a serious uncontrolled medical disorder, which in the judgment of the investigator, could have interfered with the study, or required treatment which might interfere with the study.
- Participants who in the judgment of the investigator and/or sponsor had a significant recent or current, repetitive strain injury (RSI) that may have impacted their ability to effectively participate in the full duration of the study.
Data sourced from ClinicalTrials.gov (NCT00604500). 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.