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 is an open-label, multiple-dose, study of MF/F MDI 100/10 mcg BID (2 puffs of MF/F 50/5 mcg, administered twice a day approximately 12 hours apart) in subjects 12 years of age or older, with a diagnosis of asthma or COPD of at least 12 months. The primary purpose of the study is to evaluate the performance of a new metered-dose inhaler that is integrated with a dose counter under normal patient handling

Study Type: Interventional

Study Design: Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )
  • MF/F MDI 100/10 mcg BID (two inhalations of a 50/5 mcg inhaler BID); Familiarization Period: placebo MDI without dose counter plus currently; prescribed asthma/COPD therapy; Screening Period: MDI without a dose counter; Treatment Period: MDI with a dose counter

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: MF/F MDI 100/10 mcg BID
  • MF/F MDI 100/10 mcg BID (two inhalations of 50/5 mcg inhaler BID); Familiarization Period: placebo MDI without dose counter; Screening Period: without dose counter; Treatment Period: with dose counter

Primary Measures

• Overall discrepancy rate per 100 actuations (ie, the difference between the subject-recorded number of actuations and the subject-recorded counter readout across the 4-week Treatment Period)
  • Time Frame: Primary outcome measures will be derived after completion of the 4-week Treatment Period.
    Safety Issue?: No
• Quartile discrepancy rate (ie, the difference between the subject-recorded number of actuations and the subject-recorded counter readout at each of the 4 weekly visit intervals
  • Time Frame: Primary outcome measures will be derived after completion of the 4-week Treatment Period.
    Safety Issue?: No
• Discrepancy Size (ie, magnitude of difference between the MDI dose counter readout and the number of actuations delivered by the MDI).
  • Time Frame: Primary outcome measures will be derived after completion of the 4-week Treatment Period.
    Safety Issue?: No
• End-of-Use agreement (ie, the difference in the final MDI dose counter readout and the total number of recorded actuations in the subject diary at the end-of-use).
  • Time Frame: Primary outcome measures will be derived after completion of the 4-week Treatment Period.
    Safety Issue?: No

Secondary Measures

• Overall discrepancy rate per 100 actuations for the Counterstrip.
  • Time Frame: Secondary outcome measures will be derived after completion of the 4-week Treatment Period.
    Safety Issue?: No
• Total no. of recorded subject handlings vs total no. of recorded subject handlings with no missing diary data.
  • Time Frame: Secondary outcome measures will be derived after completion of the 4-week Treatment Period.
    Safety Issue?: No
• Total no. of days in the study vs total no. of diary recorded actuations.
  • Time Frame: Secondary outcome measures will be derived after completion of the 4-week Treatment Period.
    Safety Issue?: No
• No. and percentage of subjects with at least one failed dose.
  • Time Frame: Secondary outcome measures will be derived after completion of the 4-week Treatment Period.
    Safety Issue?: No
• Safety measures including AEs, separating any ergonomic related events from other medical conditions, asthma or COPD exacerbations etc.
  • Time Frame: Secondary outcome measures will be derived after completion of the 4-week Treatment Period.
    Safety Issue?: Yes
• Subject Satisfaction Summary at Baseline and Last Visit.
  • Time Frame: Secondary outcome measures will be derived after completion of the 4-week Treatment Period.
    Safety Issue?: No

Inclusion Criteria:

• A subject must be at least 12 years of age, of either sex, and of any race, with a diagnosis of asthma or COPD of at least 12 months.
• An asthma subject's FEV1 must be >=70% and a COPD subject's FEV1 must be >=50% and have a ratio of FEV1/FVC <=0.70 (pre-bronchodilator).
• An asthmatic subject must have been using a low daily dose of ICS [either alone or in combination with a LABA] for at least 12 weeks and on a stable asthma regimen (daily dose unchanged) for at least 2 weeks prior to Screening.
• A subject must be able to demonstrate correct use of an MDI without a counter at the Screening Visit.
• A subject must demonstrate at least 90% compliance with use of the Counterstrip over the 2-week Screening Period.
• A subject must demonstrate at least 90% compliance with use of study medication over the 2-week Screening Period.
• At the Baseline Visit, an asthma subject's FEV1 or PEF must be >= 80% predicted when all restricted medications have been withheld for the appropriate intervals.
• Clinical laboratory tests, including a chest x-ray (if applicable) must be within normal limits or clinically acceptable to the investigator/sponsor.
• For all female subjects of childbearing potential, serum pregnancy test must be negative.
• An ECG must be clinically acceptable to the investigator/sponsor.
• A subject who experiences an exacerbation that results in ER treatment, hospitalization due to asthma or COPD, or treatment with additional, excluded medication (other than SABA).
• A subject who has been treated in the ER (for a severe exacerbation requiring systemic glucocorticosteroid treatment), or admitted to the hospital for management of airway obstruction within the 3 months prior to the Pre-Screening Visit.
• A subject who has ever required ventilator support for respiratory failure secondary to asthma or COPD.
• A subject who has experienced an upper or lower respiratory tract infection (viral or bacterial), including sinus or middle ear infections, within the previous 2 weeks prior to Screening and Baseline Visits.

Exclusion Criteria:

• Subjects who in the judgment of the investigator and/or sponsor have a significant recent or current, repetitive strain injury (RSI) that may impact their ability to effectively participate in the full duration of the study.
• Subjects with a serious uncontrolled medical disorder, which in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study.
• An asthmatic subject who demonstrates an increase or decrease in absolute FEV1 of >20% from the Screening Visit to the Baseline Visit.
• An asthmatic subject who experiences a decrease in AM or PM PEF below the Stability
• Limit on any 2 consecutive days prior to the Baseline Visit.
• An asthmatic subject who requires the use of > 8 inhalations per day of SABA MDI or >
• 2 nebulized treatments per day of 2.5 mg albuterol, on any 2 consecutive days from the Screening Visit to the Baseline Visit.
• A subject who experiences an exacerbation defined as a clinical deterioration of asthma or COPD, judged by investigator, that results in emergency treatment, hospitalization due to asthma or COPD, or treatment with additional, excluded medication (other than SABA) at any time from the Screening Visit up to and including the Baseline Visit.
• A subject treated in the emergency room (for a severe exacerbation requiring systemic
• ICS), or admitted to the hospital for management of airway obstruction within the 3 months prior to the Pre-Screening Visit.
• A subject who has ever required ventilator support for respiratory failure secondary to asthma or COPD.
• A subject who has experienced an upper or lower RTI , including sinus or middle ear infections, within the previous 2 weeks prior to Screening and Baseline Visits.

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 Sponsor: Schering-Plough

Overall Clinical Trial Officials and Contacts

Hendrik Nolte, MD, PhD Study Director Schering-Plough  

Overall Contact: SP Clinical Trial Registry Call Center 1-888-772-8734 

Information obtained from ClinicalTrials.gov on September 05, 2008

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