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)

Official Title: “An Open-Label, Multi-Center, Patient Handling Study of Mometasone Furoate/Formoterol Fumarate MDI With an Integrated Dose Counter in Adolescent and Adult Subjects and Adult With Asthma or COPD”

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.

Intervention(s) in this Clinical Trial

• Drug: SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )
  • MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MF/F MDI 50/5 mcg, twice a day) over a 4-week Treatment Period.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: MF/F MDI 100/10 mcg BID with dose counter
  • MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MFF MDI 50/5 mcg, twice a day) over a 4-week Treatment Period.

Primary Measures

• Overall Discrepancy Rate
  • Time Frame: 4-week Treatment Period
    Safety Issue?: No
• Overall Quartile Discrepancy Rate
  • Time Frame: 4-week Treatment Period
    Safety Issue?: No
• Overall Discrepancy Size
  • Time Frame: 4-week Treatment Period
    Safety Issue?: No
• End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population)
  • Time Frame: 4-week Treatment Period
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Schering-Plough Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00604500

Study ID Number: P04703

ClinicalTrials.gov Identifier: NCT00604500

Health Authority: United States: Food and Drug Administration