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Efficacy and Safety of Mometasone Furoate/Formoterol Fumarate in Persistent Asthma
NCT00383552Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2006
- Primary completion
- Aug 2008
- Sponsor
- Organon & Co.
- Modality
- Orthosteric Ligands
- Drugs
- mometasoneformoterol
- Conditions
- asthma
01
Overview
Phase 3, randomised, double-blind trial of mometasone and formoterol in asthma (4 arms), sponsored by Organon & Co. Primary endpoints: Area Under the Curve from 0 to 12 hours of the change from Baseline to Week 12 in Forced Expiratory Volume in One Second, Median Time-to-first Severe Asthma Exacerbation Over the 26-week Treatment Period and 1 more. Started Sep 2006; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
MF/F MDI 100/10 mcg BID
Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID
MF MDI 100 mcg BID
Mometasone Furoate MDI 100 mcg BID
F MDI 10 mcg BID
Formoterol Fumarate MDI 10 mcg BID
Placebo BID
Placebo MDI BID
03
Who it enrols
Patients >=12 years with persistent asthma for >=12 months, previously treated with low-dose inhaled corticosteroids for >=12 weeks. Must demonstrate bronchodilator reversibility (FEV1 increase >=12% and >=200 mL). Smokers and those with recent exacerbations or respiratory infections are excluded.
04
Endpoints
Primary
Area Under the Curve from 0 to 12 hours of the change from Baseline to Week 12 in Forced Expiratory Volume in One Second
Median Time-to-first Severe Asthma Exacerbation Over the 26-week Treatment Period
Number of Participants With at Least One Severe Asthma Exacerbation at Week 26
Secondary
Change From Baseline to Week 26 in the Asthma Control Questionnaire Total Score
Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities Total Score
Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of SABA
Change From Baseline in AM FEV1 Pre-dose Assessment, or Trough FEV1, at Week 12
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