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

NCT00383240 | Completed Phase 3 Results

• 2 other identifiers: P04334EUDRACT No.: 2006-001578-25;
• Study Type: interventional
• Target: 781
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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) for MF/F Versus MF

  Baseline to Endpoint (12 weeks)

• Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F

  This endpoint was to measure the time it took for 50% of subjects in a treatment arm to experience a severe asthma exacerbation (also see the posted Other Pre-specified Outcome: Number of Participants With at Least One Severe Asthma Exacerbation)

  26-week Treatment Period

Secondary Outcomes (3)

• Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score

  Baseline to Week 26

• Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score

  Baseline to week 26

• Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA)

  Baseline to Endpoint

Other Outcomes (1)

• Number of Participants With at Least One Severe Asthma Exacerbation

  Baseline to Week 26

Study Arms (4)

MF/F MDI 200/10 mcg BID

EXPERIMENTAL

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

MF MDI 200 mcg BID

EXPERIMENTAL

Drug: Mometasone furoate MDI (MF MDI) 200 mcg

F MDI 10 mcg BID

EXPERIMENTAL

Drug: formoterol fumarate 10 mcg

Placebo BID

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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

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

Also known as: SCH 418131

MF/F MDI 200/10 mcg BID

Mometasone furoate MDI (MF MDI) 200 mcg DRUG

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

Also known as: SCH 32088

MF MDI 200 mcg BID

formoterol fumarate 10 mcg DRUG

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

Also known as: Foradil

F MDI 10 mcg BID

Placebo DRUG

Placebo metered dose inhaler twice a day for 26 weeks

Placebo BID

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• \- 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
• 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:
• 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
• 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
• 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.

Sponsors & Collaborators

• Organon and Co: lead
• Novartis: collaborator

Related Publications (1)

• 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.

  PMID: 20678306 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Mometasone Furoate; BID protein, human; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2006
• First Posted: October 3, 2006
• Study Start: September 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 20, 2024
• Results First Posted: March 7, 2011

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share