Phase 3
N=746
Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)(COMPLETED)
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00383552 ↗Enrolled (actual)
746
Serious AEs
0.8%
Results posted
Oct 2011
Primary outcome: Primary: 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) — 3.94; 1.85; 4.09; 1.64 liters * hours — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID (Drug); Mometasone Furoate MDI (MF MDI) (Drug); Formoterol Fumarate 10 mcg (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
3.94; 1.85; 4.09; 1.64; 4.00; 2.53 | 0.001 sig |
| PRIMARY Median Time-to-first Severe Asthma Exacerbation Over the 26-week Treatment Period |
45.5; 54; 51.5; 27.5 | — |
| PRIMARY Number of Participants With at Least One Severe Asthma Exacerbation at Week 26 |
30; 53; 84; 86 | — |
| SECONDARY Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Total Score |
1.34; 1.29; 1.38; 1.23; -0.40; -0.32 | 0.001 sig |
| SECONDARY Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standarized Activities (AQLQ[S]) Total Score |
5.60; 5.65; 5.60; 5.76; 0.44; 0.39 | <0.001 sig |
| SECONDARY Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta Agonists (SABA) |
0.13; 0.12; 0.15; 0.13; -0.06; -0.03 | <0.001 sig |
| SECONDARY Change From Baseline in AM FEV1 Pre-dose Assessment, or Trough FEV1, at Week 12 |
2.50; 2.41; 2.47; 2.46; 0.18; 0.16 | 0.073 |
| SECONDARY AUC(0-12 Hour) of the Change From Baseline to Week 12 in FEV1 for Each Body Mass Index (BMI) Subgroup |
5.24; 3.19; 4.34; 2.22; 3.36; 3.23 | 0.015 sig |
Summary
This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, participants will receive open-label (OL) MF MDI 100 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) and by the time-to-first severe asthma exacerbation across the 26-week treatment period.
Eligibility Criteria
Inclusion Criteria
- >=12 years, either sex, any race, asthma diagnosis >=12 months that is consistent with the following: Diagnosis based on clinical history & examination, pulmonary function parameters & response to beta-2-agonists, according to international guidelines.
- Been using low daily dose of inhaled corticosteroid (ICS) (either alone or in combination with long-acting beta agonist [LABA]) >=12 weeks & been on stable asthma regimen for >=2 weeks prior to Screening. Low daily doses of ICS are:
200-500 mcg beclomethasone chlorofluorocarbon (CFC),
100-250 mcg beclomethasone hydrofluoroalkane (HFA),
200-600 mcg budesonide dry powder inhaler (DPI),
500-1000 mcg flunisolide,
100-250 mcg fluticasone,
200 mcg MF,
400-1000 mcg triamcinolone acetonide,
80 to 160 mcg ciclesonide.
Note: Dose delivery by method/modality other than these must be equivalent.
- No harm in changing current asthma therapy to investigator, subject (legal representation, if applicable) must be willing to discontinue his/her ICS or ICS/LABA combination prior to initiating MF MDI run-in medication at Screening Visit, & transferred to open-label treatment with MF MDI 100 mcg BID for 2-3 weeks prior to Baseline Visit.
- To document diagnosis of asthma & assure responsiveness to bronchodilators before randomization 1 of these can be used at Screening Visit or thereafter, but prior to Baseline Visit:
Demonstrate increase in absolute FEV1 >=12% & >=200 mL within approximately 15 to 20 minutes after administration of 4 inhalations of albuterol/salbutamol (total dose 360-400 mcg) or nebulized short-acting beta agonist (SABA) (2.5 mg) if confirmed as standard office practice, OR
Demonstrate peak expiratory flow (PEF) variability >20% expressed as percentage of the mean highest & lowest morning prebronchodilator (before taking albuterol/salbutamol) PEF over >=1 week, OR
Demonstrate diurnal variation in PEF of >20% based on difference between prebronchodilator (before taking albuterol/salbutamol) morning value & postbronchodilator value (after taking albuterol/salbutamol) from evening before, expressed as percentage of mean daily PEF value.
- At Screening Visit, FEV1 must be >=60% & =60% & =3 months prior to Screening (exception condom), & must agree to continue its use. Female of childbearing potential who is not currently sexually active must agree & consent to using birth control, should she become active. Women who have been surgically sterilized or are >=1 year postmenopausal are not considered to be of childbearing potential. Female must have negative serum pregnancy test at Screening.
Exclusion Criteria
- Increase/decrease in absolute FEV1 of >20% at any time from Screening Visit up to & including Baseline Visit. Pulmonary function tests (PFTs) will be performed in the morning.
- >8 inhalations/day of SABA MDI or >=2 nebulized treatments/day of 2.5 mg SABA on 2 consecutive days from Screening Visit up to & including Baseline Visit.
- Decrease in AM/PM PEF below Screening Period stability limit on 2 consecutive days prior to randomization.
- Asthma deterioration results in emergency treatment, hospitalization, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids, but allowing SABA) as judged by investigator at any time from Screening Visit up to & including Baseline Visit.
- Treated in emergency room (ER) (for severe asthma exacerbation requiring systemic glucocorticosteroid treatment) or admitted to hospital for management of airway obstruction within last 3 months.
- Ever required ventilator support for respiratory failure secondary to asthma.
- Upper/lower respiratory tract infection within previous 2 weeks prior to Screening & Baseline Visits. Visits can be rescheduled 2 weeks after complete resolution.
- Smoker or ex-smoker & has smoked within previous year or has cumulative smoking history >10 pack-years.
- Significant abnormal vital sign.
- Evidence upon visual inspection of sign
Data sourced from ClinicalTrials.gov (NCT00383552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.