Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)
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 100/10 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 100 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 Low-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 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 ICS (either alone or in combination with LABA) >=12 weeks
& been on stable asthma regimen for >=2 weeks prior to Screening. Low daily doses of
200-500 mcg beclomethasone CFC 100-250 mcg beclomethasone HFA 200-600 mcg budesonide 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
- 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
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 SABA (2. 5 mg) if confirmed as standard office practice, OR Demonstrate
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
- At Screening Visit, FEV1 must be >=60% & <=90% predicted.
- At Baseline Visit, FEV1 must be >=60% & <=85% predicted when all restricted drugs have
been withheld for appropriate intervals.
- Lab tests at Screening Visit must be normal or acceptable to investigator/sponsor and
include serum pregnancy for females of child-bearing potential). ECG at Screening
Visit, using centralized trans-telephonic technology must be acceptable to
investigator. Chest x-ray performed at Screening Visit or within 12 months prior to
Screening Visit must be acceptable to investigator.
- Subject (legal representation, if applicable) must be willing to give written informed
consent & able to adhere to schedules.
- A non-pregnant of childbearing potential must use birth control. Includes: hormonal
contraceptives including hormonal vaginal ring, hormonal implant or depot-injectable;
IUD; medically prescribed topically-applied transdermal contraceptive patch; condom in
combination with spermicide; monogamous relationship with male who had vasectomy.
Started birth control method >=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.
- Increase/decrease in absolute FEV1 of >20% at any time from Screening Visit up to &
including Baseline Visit. 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 ER (for severe asthma exacerbation requiring systemic glucocorticosteroid
treatment) or admitted to hospital for management of airway obstruction within last 3
- 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 significant oropharyngeal candidiasis at Baseline
or earlier with or without treatment. If there is evidence at Screening or
Pre-Baseline Visit, may be treated as appropriate & Baseline Visit can be scheduled
- History of significant renal, hepatic, cardiovascular, metabolic, neurologic,
hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or other
which, in judgment of investigator, could interfere with study or require treatment
which might interfere with study. Examples include (but are not limited to)
insulin-dependent diabetes, hypertension being treated with beta-blockers, active
hepatitis, coronary artery disease, arrhythmia, significant QTc prolongation (ie QTcF
or QTcB [Fridericia or Bazett corrections, respectively >500 msecs), stroke, severe
rheumatoid arthritis, chronic open-angle glaucoma or posterior subcapsular cataracts
(including prior cataract surgery), AIDS, or conditions that may interfere with
respiratory function such as COPD, chronic bronchitis, emphysema, bronchiectasis,
cystic fibrosis. Others which are well-controlled & stable (eg hypertension not
requiring beta-blockers) will not prohibit participation if deemed appropriate by
- Allergic/intolerant of glucocorticoids, beta-2-agonists, or any inactive excipients in
- Female who is breast-feeding, pregnant, or intends to become pregnant while in study.
- Illicit drug user.
- HIV positive (testing not done).
- Unable to use oral MDI inhaler.
- Has been taking any restricted medications prior to Screening without meeting required
- Cannot adhere to prohibited & permitted concomitant medications.
- May not participate in same study at another site. Cannot participate in different
study at any site, during same time.
- Must not be randomized into study more than once.
- No person directly associated with administration of study may participate.
- Previously participated in trial with MF/F.
Locations and Contacts
Investigational Site 42, Rousse 7002, Bulgaria
Investigational Site 43, Plovdiv 4003, Bulgaria
Investigational Site 46, Sofia 1233, Bulgaria
Investigational Site 45, Plovdiv 4000, Bulgaria
Investigational Site 38, Sofia 1431, Bulgaria
Investigational Site 44, Plovdiv 4000, Bulgaria
Investigational Site 37, Sofia 1431, Bulgaria
Investigational Site 39, Sofia 1431, Bulgaria
Investigational Site 28, Toronto M4V 1R2, Canada
Investigational Site 29, Ottawa K1Y 4G2, Canada
Investigational Site 36, Mississauga L5A 3V4, Canada
Investigational Site 47, Bogota, Colombia
Investigational Site 48, Bogota, Colombia
Investigational Site 49, Bogota, Colombia
Investigational Site 50, San Jose, Costa Rica
Investigational Site 52, San Jose, Costa Rica
Investigational Site 53, Zagreb, Croatia
Investigational Site 54, Zagreb, Croatia
Investigational Site 58, Zagreb 10000, Croatia
Investigational Site 55, Zagreb 10000, Croatia
Investigational Site 56, Rijeka 51000, Croatia
Investigational Site 57, Zagreb 10000, Croatia
Investigational Site 59, Quito, Ecuador
Investigational Site 60, Guayaquil, Ecuador
Investigational Site 61, Tartu 51014, Estonia
Investigational Site 63, Tallinn 13619, Estonia
Investigational Site 65, Guatemala, Guatemala
Investigational Site 66, Guatemala, Guatemala
Investigational Site 67, Guamalate, Guatemala
Investigational Site 68, Komarom 2900, Hungary
Investigational Site 72, Deszk 6772, Hungary
Investigational Site 73, Miskolc 3526, Hungary
Investigational Site 70, Torokbalint, Hungary
Investigational Site 75, Nyiregyhaza 4412, Hungary
Investigational Site 76, Budapest 1095, Hungary
Investigational Site 77, Budapest 1095, Hungary
Investigational Site 69, Mosonmagyarovar 9200, Hungary
Investigational Site 71, Budapest 1121, Hungary
Investigational Site 74, Kecskemet 6000, Hungary
Investigational Site 79, Guadalajara 44280, Mexico
Investigational Site 78, Guadalajara 44100, Mexico
Investigational Site 81, Mexico 52763, Mexico
Investigational Site 87, Lodz 93-513, Poland
Investigational Site 94, Moscow 115478, Russian Federation
Investigational Site 95, Moscow 123128, Russian Federation
Investigational Site 96, Saint Petersburg 193231, Russian Federation
Investigational Site 97, Saint Petersburg 194291, Russian Federation
Investigational Site 100, Kazan 420012, Russian Federation
Investigational Site 101, 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
Investigational Site 1, KIRKLAND, Washington 98034, United States
Starting date: September 2006
Ending date: August 2008
Last updated: June 16, 2008