Clinical Trial to Assess Efficacy, Safety, Treatment Adherence and Quality of Life Impact of Mometasone Furoate in Asthmatic Patients (Study P04879)(TERMINATED)

NCT00687531 | Terminated Phase 4 Results

• 1 other identifier: P04879
• Study Type: interventional
• Target: 385
• Locations: 0 countries
• Sites: N/A

Brief Summary

Open label, 12-week clinical trial to assess efficacy, safety, treatment adherence and Quality of Life impact of Mometasone Furoate dry powder 400 mcg once-daily in persistent mild-moderate asthmatic patients at least 12 years old. Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in 1 Second (FEV1)

  Spirometry was performed to measure FEV1, which is the amount of air the participant is able to exhale in 1 second. Normal values for FEV1 in healthy people depend on age and gender, but values between 80% and 120% of the normal value is considered good. Increased FEV1 indicates improvement in asthma control.

  Day 1 and Week 12

Secondary Outcomes (10)

• Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR)

  Day 1 and Week 12

• Number of Items in the Asthma Quality of Life (QOL) Questionnaire and the General QOL Questionnaire That Had a Significant (Positive) Change From Baseline to Endpoint

  Day 1 and Week 12

• Morning and Evening Asthma Symptoms Based on a 3 Point Scale (4 Individual Symptoms) and 24 Points (Summed).

  Day 1 and Week 12

• Number of Nocturnal Awakenings

  Day 1 and Week 12

• Number of Puffs of Salbutamol Used Daily

  Day 1 and Week 12

Study Arms (1)

Mometasone Furoate

EXPERIMENTAL

Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.

Drug: Mometasone Furoate

Interventions

Mometasone Furoate DRUG

Mometasone Furoate 400 mcg once daily, in the evening through 12 weeks.

Also known as: SCH 32088

Mometasone Furoate

Eligibility Criteria

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

You may qualify if:

• Willingness to participate and comply with procedures by signing a written informed consent
• years of age or older of either gender and any race
• Women of childbearing potential (includes women who are less than 1 year postmenopausal and currently are or will become sexually active during the study) must be using or agree to use an acceptable method of birth control unless they are surgically sterilized
• Must understand and be able to adhere to dosing and visit schedules, and agree to record symptom severity scores, PEFR values, medication times, and concomitant medications accurately and consistently in a daily diary.
• Diagnosed history of mild-moderate persistent asthma for at least 12 months.
• FEV1 must be \>60% of predicted normal or personal best FEV1 during the last 12 months.
• Using daily inhaled corticosteroids for at least 30 days prior to Screening. In the Screening Visit patients FEV1 should be \>= 65% to \<= 90% predicted.
• Asthma Symptom Total daily (AM+PM) severity score at Screening Visit should be \<= 2.
• For two weeks prior to Screening, subjects must have been on a stable regimen of one of the following twice daily regimen: fluticasone propionate (FP) \>= 100 - \<= 500 mcg/day; budesonide (BUD) \>= 200 - \<= 1000mcg/day; beclomethasone dipropionate (BDP) \>= 200 - \<= 1000 mcg/day; triamcinolone acetonide (TA) \>= 400 - \<= 2000 mcg/day
• During the inhaled corticosteroid (ICS) Dose Reduction period (max. of 4 weeks; min. of 1 week) of sequential ICS Dose Reduction (approximately 50% reduction in daily dose or discontinue according treatment scheme), subjects must demonstrate a measurable loss of asthma control, with both A) Decreased Lung Function (from the Screening value in absolute FEV1 of \>= 10% or \>= 220ml OR a decrease in AM PEFR of 25% from the average value for the pre-ICS Dose Reduction period on at least 2 consecutive days out of the last 7 days) AND B) Increased Symptoms (Total AM and PM symptom score of \>= 10 out of 24 (using 0-3 scale for each of 4 individual symptoms) on at least 2 days out of the last 7 days OR Increased use of rescue medication from the average value for the pre-ICS Dose Reduction period (one week) of \>= 2 puffs on at least 2 days out of the last 7 days)
• Once criterion above have been fulfilled, subjects can be initiated if the FEV1 is 60%-80% predicted
• Subjects must agree to inform their usual treating physicians of their participation in this study

You may not qualify if:

• Females who are pregnant or breast-feeding.
• Subjects who have not observed the designated washout periods for any of the prohibited medications
• Subjects who have used any investigational product within 30 days or any antibodies for asthma or allergic rhinitis in the past 90 days prior to enrollment.
• Subjects who have any clinically significant deviation from normal in the physical examination that may interfere with the study evaluations or affect subject safety.
• Subjects who have required systemic steroids within the previous month.
• Subjects who are allergic or have an idiosyncratic reaction to corticosteroids.
• Subjects who have required inpatient hospitalization for asthma control within the previous 3 months, or more than once in the previous 6 months.
• Subjects with clinical evidence of chronic obstructive pulmonary disease or lung diseases other than asthma.
• Subjects who have experienced an upper or lower respiratory tract infection within the previous 2 weeks prior to the Screening Visit.
• Subjects with evidence of clinically significant oropharyngeal candidiasis
• Subjects with any clinically significant immunologic, metabolic, cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease (other than asthma), or any other disorder which may interfere with the study evaluations or affect subject safety.
• Subjects with a history of drug abuse, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Asthma

Interventions

Mometasone Furoate

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

Limitations and Caveats

Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

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: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: November 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 24, 2024
• Results First Posted: July 20, 2011

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share