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)

NCT ID: NCT00604500

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-01
• Study Completion Date: 2008-11-01

Brief 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.

Conditions

Asthma; COPD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Weinstein C, Staudinger H, Scott I, Amar NJ, LaForce C. Dose counter performance of mometasone furoate/formoterol inhalers in subjects with asthma or COPD. Respir Med. 2011 Jul;105(7):979-88. doi: 10.1016/j.rmed.2011.01.013. Epub 2011 Mar 12.

Reference Type: DERIVED

PMID: 21398104 (View on PubMed)

Other Identifiers

3462123

Identifier Type: -

Identifier Source: secondary_id

P04703

Identifier Type: -

Identifier Source: org_study_id