NCT00604500

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)

Completed Phase 3 Results posted Last updated 20 May 2024

What this trial tests

Phase 3 trial testing SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F ) in Asthma in 272 participants. Completed in 1 November 2008.

Timeline

1 March 2008

Primary endpoint
1 November 2008

1 November 2008

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	272
Start date	1 March 2008
Primary completion	1 November 2008
Estimated completion	1 November 2008

Drugs / interventions tested

• SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F ) — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →
• COPD — all drugs for COPD →

Sponsor

Organon and Co — full company profile →

Who can join

12 and older, any sex, with Asthma or COPD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Discrepancy Rate Primary · 4-week Treatment Period

Overall discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded dose counter readout across the 4-week Treatment Period. The Overall Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies across all participants who used at least 90% of the labeled actuations divided by the total number of actuations in the same participant population (Completer Population).

Group	Value	95% CI
MF/F MDI 100/10 mcg BID (With Dose Counter)	0.13

Overall Quartile Discrepancy Rate Primary · 4-week Treatment Period

Quartile discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded counter readout at each of the 4 weekly visit intervals \[ie, quartiles\] to evaluate whether there was any difference in agreement over the life of the inhaler. The Quartile Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies per Quartile across all participant who used at least 90% of the labeled actuations divided by the total number of actuations per Quartile in the same population.

Group	Value	95% CI
MF/F MDI 100/10 mcg BID (With Dose Counter)	0.13

Overall Discrepancy Size Primary · 4-week Treatment Period

Discrepancy Size refers to the magnitude of the discrepancy between the dose counter readout and the number of recorded actuations (definition of discrepancy). Overall Discrepancy Size was calculated as 100 multiplied by the sum of the absolute values from each Dose Counter Discrepancy Size across all participants who used at least 90% of the labeled actuations divided by the total number of recorded actuations in the same participant population.

Group	Value	95% CI
MF/F MDI 100/10 mcg BID (With Dose Counter)	0.14

End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population) Primary · 4-week Treatment Period

The difference in the final MDI dose counter readout and the total number of recorded actuations at the end-of-use. Dose Counter end-of-use agreement was calculated as the sum of the absolute difference between the final dose counter readout and the number of recorded actuations across all participants who used at least 90% of the labeled actuations (excluding participants who used the inhaler beyond the labeled number of actuations) divided by the total number of participants in this population. No participant used more than two inhalers during the treatment period.

Group	Value	95% CI
MF/F MDI 100/10 mcg BID (With Dose Counter)	175

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MF/F MDI 100/10 mcg BID

Serious: 1/272 (0%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	MF/F MDI 100/10 mcg BID
Oedema Peripheral	General disorders	—

Most-reported serious reactions: Oedema Peripheral.

Data from ClinicalTrials.gov NCT00604500 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Dose counter performance of mometasone furoate/formoterol inhalers in subjects with asthma or COPD.
   Weinstein C, Staudinger H, Scott I, Amar NJ, et al · · 2011 · cited 13× · PMID 21398104 · DOI 10.1016/j.rmed.2011.01.013