Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED)

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID; Drug: formoterol fumarate 10 mcg; Drug: Mometasone furoate MDI (MF MDI) 200 mcg; Drug: Placebo

• Registration Number: NCT00383240
• Lead Sponsor: Organon and Co

Brief Summary

This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate (MF) /formoterol fumarate (F)\[MF/F\] metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by The Area Under the Curve From 0 to 12 Hours \[AUC\](0-12 hours) of the Change From Baseline to the Week 12 Endpoint

in Forced Expiratory Volume in One Second (FEV1) \[Time Frame: Baseline to Week 12\] and Time-to-First Severe Asthma Exacerbation across the 26-week treatment period.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-29
• Study First Submitted QC: 2006-09-29
• Study First Posted: 2006-10-03
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Disposition First Submitted: 2009-10-22
• Disposition First Submitted QC: 2009-10-22
• Disposition First Posted: 2009-10-26
• Results First Submitted: 2010-06-30
• Results First Submitted QC: 2011-02-10
• Results First Posted: 2011-03-07
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 781

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MF/F MDI 200/10 mcg BID	mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID	-
F MDI 10 mcg BID	formoterol fumarate 10 mcg	-
MF MDI 200 mcg BID	Mometasone furoate MDI (MF MDI) 200 mcg	-
Placebo BID	Placebo	-

Primary Outcome Measures

Name	Time	Method
Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF	Baseline to Endpoint (12 weeks)
Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F	26-week Treatment Period	This endpoint was to measure the time it took for 50% of subjects in a treatment arm to experience a severe asthma exacerbation (also see the posted Other Pre-specified Outcome: Number of Participants With at Least One Severe Asthma Exacerbation)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA)	Baseline to Endpoint	Baseline is the proportion of nights of last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. Standard deviation is pooled.
Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score	Baseline to Week 26	AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). Standard deviations are pooled.
Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score	Baseline to week 26	ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case).