drugset / Trial / 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)

NCT00604500

Phase 3 Completed 272 enrolled Organon and Co Novartis · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2008-03-01
Primary completion
2008-11-01
Completion
2008-11-01

Drugs

EvaluationDrugModalityDoseRoute
Background Formoterol Furoate Unknown 10 ug Inhaled
Background Mometasone furoate Other / unclassified 100 ug Inhaled