Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID (Drug); Mometasone furoate MDI (MF MDI) (Drug); formoterol fumarate 10 mcg (Drug); Placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Schering-Plough
Official(s) and/or principal investigator(s):
Hendrik Nolte, MD, PhD, Study Director, Affiliation: Allergy/Respiratory Diseases/Clinical Immunology, Schering-Plough
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, 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 mean change from Baseline to
Week 12 in area under the forced expiratory volume in one second concentration time curve
from 0 to 12 hours (FEV1 AUC[0-12 hr]).
Official title: A 26-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate/Formoterol Fumarate Combination Formulation Compared With Mometasone Furoate and Formoterol Monotherapy in Subjects With Persistent Asthma Previously Treated With Medium-Dose Inhaled Glucocorticosteroids
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: AUC(0-12 hr) of change from Baseline FEV1 for MF/F vs MF. Average of the 2 predose FEV1 measurements at Baseline will be subtracted from each of the serial measurements over the 12-hr. period.
Secondary outcome: For MF/F vs placebo:
Change from Baseline in AQLQ(S) and ACQ total score and proportion of nights across the treatment period with nocturnal awakenings due to asthma which require use of SABA.
Minimum age: 12 Years.
Maximum age: N/A.
- >=12 years, either sex, any race, asthma diagnosis >=12 months following: Diagnosis
based on clinical history & examination, pulmonary parameters & response to
beta-2-agonists, according to international guidelines.
- Been using medium daily dose of ICS (either alone or in combination weeks & been on
stable asthma regimen for >=2 weeks prior to Screening. doses of ICS are:
>500-1000 mcg beclomethasone CFC >250-500 mcg beclomethasone HFA budesonide DPI >1000-2000
mcg flunisolide >250-500 mcg fluticasone >400 2000 mcg triamcinolone acetonide >160 to 320
mcg ciclesonide Note: Dose delivery method/modality other than these must be equivalent.
- No harm in changing current asthma therapy to investigator, subject must be willing to
discontinue his/her ICS or ICS/LABA combination initiating MF MDI run-in medication at
Screening Visit, & transferred treatment with MF MDI 200 mcg BID for 2-3 weeks prior
- To document diagnosis of asthma & ensure responsiveness to randomization 1 of these
can be used at Screening Visit or thereafter, but Visit: Demonstrate increase in
absolute FEV1 >=12% & >=200 mL approximately after administration of 4 inhalations of
albuterol/salbutamol (total dose of 360 nebulized SABA (2. 5 mg) if confirmed as
standard office practice, OR Demonstrate variability >20% expressed as percentage of
the mean highest & lowest morning prebronchodilator PEF over >=1 week, OR Demonstrate
diurnal variation in on difference between prebronchodilator (before taking
albuterol/salbutmaol) postbronchodilator (after taking albuterol/salbutamol) value
from evening percentage of mean daily PEF value on any day during the open-label Run
- At Screening Visit, FEV1 must be >=60% & <=90% predicted.
- At Baseline Visit, FEV1 must be >=60% & <=85% predicted been withheld for appropriate
- Lab tests at Screening Visit must be normal or acceptable to serum pregnancy for
females of child-bearing potential. ECG at Screening centralized trans-telephonic
technology must be acceptable to investigator. performed at Screening Visit or within
12 months prior to Screening Visit acceptable to investigator.
- Subject (legal representation, if applicable) must be willing to give consent & able
to adhere to schedules.
- A non-pregnant female of childbearing potential must use birth contraceptives;
hormonal vaginal ring, hormonal implant or depot medically prescribed
topically-applied transdermal contraceptive patch; combination with spermicide;
monogamous relationship with male who Started birth control method = 3 months prior to
Screening (exception agree to continue its use. Female of childbearing potential who
is not currently active must agree & consent to using birth control, should she become
have been surgically sterilized or are >=1 year postmenopausal are not childbearing
potential. Female must have negative serum pregnancy test order to be considered
eligible for the open-label MF MDI
- Increase/decrease in absolute FEV1 of >20% while using ICS at any Visit up to &
including Baseline Visit.
- >8 inhalations/day of SABA MDI or >=2 nebulized treatments/day consecutive days from
Screening Visit up to& including Baseline Visit.
- Decrease in AM/PM PEF below Screening Period stability limit on any 2 consecutive days
prior to randomization.
- Asthma deterioration results in emergency treatment, hospitalization due to asthma, or
treatment with additional, excluded asthma medication (including oral or other
systemic allowing SABA) as judged by investigator at any time from Screening including
- Treated in ER (for severe asthma exacerbation requiring systemic treatment) or
admitted to hospital for management of airway obstruction months.
- Ever required ventilator support for respiratory failure secondary to
- Upper/lower respiratory tract infection within previous 2 weeks prior to Baseline
Visits. Visits can be rescheduled 2 weeks after complete resolution.
- Smoker or ex-smoker & has smoked within previous year or has history >10 pack-years.
- Significant abnormal vital sign.
- Evidence upon visual inspection of significant oropharyngeal earlier with or without
- History of significant renal, hepatic, cardiovascular, metabolic, ophthalmologic,
respiratory, gastrointestinal, cerebrovascular, or other significant medical illness
or disorder which, in the judgement of investigator, could interfere with study or
require treatment which might study. Examples include (but are not limited to)
insulin-dependentbeing treated with beta-blockers, active hepatitis, coronary artery
disease, significant QTc prolongation (ie QTcF or QTcB [Fridericia or Bazett
corrections, respectively >500 msecs), stroke, severe rheumatoid arthritis, or
posterior subcapsular cataracts (including prior cataract surgery), AIDS, that may
interfere with respiratory function such as COPD, chronic bronchiectasis, cystic
fibrosis. Others which are well-controlled & stable not requiring beta-blockers) will
not prohibit participation if deemed appropriate investigator.
- Allergic/intolerant of glucocorticoids, beta-2-agonists, or any drugs.
- Female who is breast-feeding, pregnant, or intends to become pregnant
- Illicit drug user.
- HIV positive (testing not done).
- Unable to use oral MDI inhaler.
- Has been taking any restricted medications prior to Screening without washout.
- Cannot adhere to prohibited & permitted concomitant medications.
- May not participate in same study at another site. In addition, a subject cannot
participate in a different investigational study at any site, during the same
timeframe of this study.
- Must not be randomized into study more than once.
- No person directly associated with administration of study may
- Previously participated in trial with MF/F.
Locations and Contacts
Investigational Site 24, Quebec G1V 4M6, Canada
Investigational Site 26, Ottawa K1Y 4G2, Canada
Investigational Site 36, Mississauga L5A 3V4, Canada
Investigational Site 25, Toronto M4V 1R2, Canada
Investigational Site 47, Bogota, Colombia
Investigational Site 116, Bogota, Colombia
Investigational Site 117, Bogota, Colombia
Investigational Site 48, San Jose, Costa Rica
Investigational Site 50, San Jose, Costa Rica
Investigational Site 49, San Jose, Costa Rica
Investigational Site 51, Zagreb 10000, Croatia
Investigational Site 52, Zagreb 10000, Croatia
Investigational Site 53, Zagreb 10000, Croatia
Investigational Site 55, Zagreb 10000, Croatia
Investigational Site 56, Kantrida 53 51000, Croatia
Investigational Site 79, Copenhagen NV, Denmark
Investigational Site 79, Copenhagen, Denmark
Investigational Site 57, Quito, Ecuador
Investigational Site 58, Guayaquil, Ecuador
Investigational Site 59, Tartu 51014, Estonia
Investigational Site 60, Tallinn 13419, Estonia
Investigational Site 61, Tallinn 13619, Estonia
Investigational Site 62, Guatemala, Guatemala
Investigational Site 63, Guatemala, Guatemala
Investigational Site 64, Guatemala, Guatemala
Investigational Site 65, Komarom 2900, Hungary
Investigational Site 66, Mosonmagyarovar 9200, Hungary
Investigational Site 67, Torokbalint, Hungary
Investigational Site 68, Budapest 1121, Hungary
Investigational Site 69, Deszk 6772, Hungary
Investigational Site 70, Miskolc 3526, Hungary
Investigational Site 71, Kecskemet 6000, Hungary
Investigational Site 72, Nyiregyhaza 4412, Hungary
Investigational Site 73, Budapest 1095, Hungary
Investigational Site 74, Budapest 1122, Hungary
Investigational Site 75, Guadalajara 44100, Mexico
Investigational Site 76, Guadalajara 44280, Mexico
Investigational Site 78, Mexico 52763, Mexico
Investigational Site 206, Monterrey, N.L., Mexico
Investigational Site 82, Katowice 40-752, Poland
Investigational Site 84, Olawa, Poland
Investigational Site 85, Lodz 93-513, Poland
Investigational Site 86, Pozan 60-693, Poland
Investigational Site 92, Moscow 115478, Russian Federation
Investigational Site 93, Moscow 123128, Russian Federation
Investigational Site 94, Saint Petersburg 193231, Russian Federation
Investigational Site 95, Saint Petersburg 194291, Russian Federation
Investigational Site 97, Moscow 125206, Russian Federation
Investigational Site 98, Kazan 420012, Russian Federation
Investigational Site 99, Saint Petersburg 197022, Russian Federation
Investigational Site 124, Saint Petersburg 194291, Russian Federation
Investigational Site 125, Saint Petersburg 198216, Russian Federation
Investigational Site 16, Normal, Illinois 61761, United States
Starting date: September 2006
Ending date: September 2008
Last updated: June 16, 2008