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

NCT ID: NCT00383240

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 781 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-09-30

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MF/F MDI 200/10 mcg BID

Group Type: EXPERIMENTAL

mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID

Intervention Type: DRUG

MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks

MF MDI 200 mcg BID

Group Type: EXPERIMENTAL

Mometasone furoate MDI (MF MDI) 200 mcg

Intervention Type: DRUG

MF 200 mcg via metered dose inhaler twice daily for 26 weeks

F MDI 10 mcg BID

Group Type: EXPERIMENTAL

formoterol fumarate 10 mcg

Intervention Type: DRUG

F via metered dose inhaler 10 mcg twice a day for 26 weeks

Placebo BID

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo metered dose inhaler twice a day for 26 weeks

Interventions

mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID

MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks

Intervention Type: DRUG

Mometasone furoate MDI (MF MDI) 200 mcg

MF 200 mcg via metered dose inhaler twice daily for 26 weeks

Intervention Type: DRUG

formoterol fumarate 10 mcg

F via metered dose inhaler 10 mcg twice a day for 26 weeks

Intervention Type: DRUG

Placebo

Placebo metered dose inhaler twice a day for 26 weeks

Intervention Type: DRUG

Other Intervention Names

SCH 418131; SCH 32088; Foradil

Eligibility Criteria

Inclusion Criteria

• A subject must have been using a medium daily dose of inhaled glucocorticosteroid (ICS) (either alone or in combination with a long-acting beta agonist (LABA)) for at least 12 weeks and must have been on a stable regimen (daily dose unchanged) for at least 2 weeks prior to Screening. Medium daily doses of ICS are defined as follows:

• >500 to 1000 mcg beclomethasone chlorofluorocarbon (CFC)
• >250 to 500 mcg beclomethasone hydrofluoroalkane (HFA)
• >600 to 1000 mcg budesonide dry powder inhaler (DPI)
• >1000 to 2000 mcg flunisolide
• >250 to 500 mcg fluticasone
• 400 mcg MF
• >1000 to 2000 mcg triamcinolone acetonide

Note: Dose delivery by method or modality other than those noted above must be equivalent.

• If, based upon the medical judgment of the investigator, there is no inherent harm in changing the subject's current asthma therapy, then the subject (and parent/guardian, if applicable) must be willing to discontinue his/her prescribed ICS or ICS/LABA combination at the Screening Visit, and be transferred to open-label treatment with MF MDI 200 mcg BID for 2 to 3 weeks prior to the Baseline/Randomization Visit.
• To document the diagnosis of asthma and assure the subject's responsiveness to bronchodilators before randomization one of the following methods can be used at the Screening Visit, Day -14, or thereafter, but prior to the Baseline Visit:

1. The subject must demonstrate an increase in absolute FEV1 of at least 12% and at least 200 mL within 15 minutes after administration of four inhalations of albuterol/salbutamol (total dose of 360 to 400 mcg) or of nebulized SABA (2.5 mg) if confirmed as standard office practice, OR

2. The subject must demonstrate a peak expiratory flow (PEF) variability of more than 20% expressed as a percentage of the highest and lowest morning prebronchodilator PEF over at least 1 week, OR

3. The subject must demonstrate a diurnal variation in PEF of more than 20% based on the difference between the prebronchodilator morning value and the postbronchodilator value from the evening before, expressed as a percentage of the mean daily PEF value.

• At the Screening Visit, the subject's FEV1 must be ≥60% and ≤90% predicted.
• At the Baseline Visit, the subject's FEV1 must be ≥60% and ≤85% predicted when all restricted medications have been withheld for the appropriate intervals.
• Clinical laboratory tests (complete blood counts [CBC], blood chemistries, and urinalysis) conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor. An electrocardiogram (ECG) using a centralized trans-telephonic technology at the Screening Visit must be clinically acceptable to the investigator. A chest x-ray performed at the Screening Visit, or within 12 months prior to the Screening Visit, must be clinically acceptable to the investigator.
• A female subject of childbearing potential must have been using a medically acceptable, adequate form of birth control. This includes: 1) hormonal contraceptives as prescribed by a physician (oral combined, hormonal implant); 2) medically prescribed intra-uterine device (IUD); 3) condom in combination with a spermicide (double barrier method); 4) monogamous relationship with a male partner who has had a vasectomy. The subject must have started this birth control method at least 3 months prior to Screening (with the exception of condom in combination with spermicide), and must agree to continue its use for the duration of the study. A female subject of childbearing potential who is not currently sexually active must agree and consent to using a medically acceptable birth control method should she become sexually active during the course of this study. Women who have been surgically sterilized or are at least 1 year postmenopausal are not considered to be of childbearing potential. A female subject of childbearing potential must have a negative serum pregnancy test at Screening in order to be considered eligible for enrollment.

Exclusion Criteria

• A subject who demonstrates a change (increase or decrease) in absolute FEV1 of >20% at any time from the Screening Visit up to and including the Baseline Visit.
• A subject who requires the use of greater than eight inhalations per day of SABA MDI, or two or more nebulized treatments per day of 2.5 mg SABA, on any 2 consecutive days from the Screening Visit up to and including the Baseline Visit.
• A subject who experiences a decrease in AM or PM PEF below the Screening Period stability limit on any 2 consecutive days prior to Randomization.
• A subject who experiences an occurrence of any clinical deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA) as judged by the clinical investigator at any time from the Screening Visit up to and including the Baseline Visit.
• A subject who is a smoker or ex-smoker and has smoked within the previous year or has had a cumulative smoking history >10 pack-years

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Nathan RA, Nolte H, Pearlman DS; P04334 Study Investigators. Twenty-six-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg combination treatment in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids. Allergy Asthma Proc. 2010 Jul-Aug;31(4):269-79. doi: 10.2500/aap.2010.31.3364. Epub 2010 Jul 30.

Reference Type: DERIVED

PMID: 20678306 (View on PubMed)

Other Identifiers

EUDRACT No.: 2006-001578-25;

Identifier Type: -

Identifier Source: secondary_id

P04334

Identifier Type: -

Identifier Source: org_study_id