AsthmaPhase 4APEGONCT00687531

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

A Phase 4 study testing Mometasone Furoate in people with Asthma, run by Organon and Co.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Asthma
What is being tested?: Mometasone Furoate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 385 participants
Where: No sites listed yet
Study dates: Nov 2006to Sep 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Willingness to participate and comply with procedures by signing a written informed consent
12 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.

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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

Who cannot join

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.

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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

About this study

Official title: 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
Being tested: Mometasone Furoate
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mometasone FuroateDrug
Also called SCH 32088
Mometasone Furoate 400 mcg once daily, in the evening through 12 weeks.

Study groups in NCT00687531
Study group	Role	What they receive
Mometasone Furoate	Experimental	Mometasone Furoate 400 mcg once daily in the evening through 12 weeks. Receives: Drug: Mometasone Furoate

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1 and Week 12

Secondary outcomes (10)

Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR)
Participants were to record their daily AM and PM PEFR values in a diary. PEFR can be measured using a peak flow meter that was given to the participant. Normal readings are based on a person's gender, age, and height. A reading of 80 to 100% of the usual or normal peak flow readings indicate that the asthma is under good control. Increased PEFR indicates improvement in asthma control.
Measured: 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
Questionnaires consisted of items such as General Health Condition (excellent/very good/good/regular/bad), Difficulty to Breathe (always/almost always/considerable part of time/partially/few amount of time/almost never/never), General Asthma Limitations (completely/a lot/enough to be considered/regular/a few/almost nothing/nothing), etc...
The questionnaires together consisted of 44 questions, each question with categorical variables as response. A Friedman test was performed to determine the significance of change in samples from baseline to endpoint, for each question.
Measured: Day 1 and Week 12
Morning and Evening Asthma Symptoms Based on a 3 Point Scale (4 Individual Symptoms) and 24 Points (Summed).
The symptoms of cough, chest tightness, wheezing, and shortness of breath were each to be graded on a scale of 0 to 3 with 0 being no symptoms present and 3 being very marked symptoms which was disturbing most of the time. Scores were to have been recorded at 12AM and 12PM for a total of 24 points summed.
Measured: Day 1 and Week 12
Number of Nocturnal Awakenings
Measured: Day 1 and Week 12
Number of Puffs of Salbutamol Used Daily
Measured: Day 1 and Week 12
Investigator's Assessment of Response to Therapy Based on a 5-point Scale
The investigator will assess the subject's response to therapy by interviewing the subject and comparing the current level of symptoms from baseline. A scale of 1 to 5 will be used with 1 being much improved (AM and PM symptom severety/frequency improve >75% from baseline) and 5 being much worse (AM and PM symptom severity/frequency got more than 75% worse from baseline).
Measured: Baseline, Week 12
Patient's Assessment of Response to Therapy Based on a 5-point Scale
A scale of 1 to 5 will be used with 1 being much improved (AM and PM symptom severety/frequency improve >75% from baseline) and 5 being much worse (AM and PM symptom severity/frequency got more than 75% worse from baseline).
Measured: Baseline, Week 12
Number of Participants With One or More Mild, Moderate or Severe Asthma Exacerbations
Exacerbation severity will be characterized based on exacerbation classification from the Global Initiative for Asthma (GINA) workshop 2005 and the National Heart Lung and Blood Institute (NHLBI) asthma guidelines.
Measured: Day 1 and Week 12
Number of Participants Who Adhered to Treatment
The compliance was measured via medication consumption. In the end of the last week of study (Week 12), a review of the remaining study drug in the initial prescribed Twisthaler device was done. A Twisthaler reading of 0 indicates no study drug left and full compliance.
Measured: Day 1 to Week 12
Number of Participants With Use of Rescue Medication in Each Episode
Measured: Day 1 and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Sep 2009

First posted30 May 2008 (estimated)
Study startNov 2006
Primary completionSep 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 385 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00687531
Sponsor's protocol ID: P04879
Acronym: APEGO
Status last verified: Feb 2022
First submitted: 27 May 2008
Last updated: 24 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00687531
Acronym / sponsor ID: APEGO / P04879
Conditions: Asthma
Phase: Phase 4
Study type: Interventional
Recruitment status: Terminated
Enrolment: 385 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 30 May 2008 (estimated)
Results: Posted 20 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Mometasone Furoate	Experimental	Drug: Mometasone FuroateMometasone Furoate 400 mcg once daily in the evening through 12 weeks.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (12 listed)

Willingness to participate and comply with procedures by signing a written informed consent
12 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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mometasone FuroateAlso: SCH 32088Mometasone Furoate 400 mcg once daily, in the evening through 12 weeks.	Drug	Mometasone Furoate

Primary outcome

Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Day 1 and Week 12
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.

10 secondary outcomes

Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR)
Time frame: 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
Time frame: Day 1 and Week 12
Morning and Evening Asthma Symptoms Based on a 3 Point Scale (4 Individual Symptoms) and 24 Points (Summed).
Time frame: Day 1 and Week 12
Number of Nocturnal Awakenings
Time frame: Day 1 and Week 12
Number of Puffs of Salbutamol Used Daily
Time frame: Day 1 and Week 12
Investigator's Assessment of Response to Therapy Based on a 5-point Scale
Time frame: Baseline, Week 12
Patient's Assessment of Response to Therapy Based on a 5-point Scale
Time frame: Baseline, Week 12
Number of Participants With One or More Mild, Moderate or Severe Asthma Exacerbations
Time frame: Day 1 and Week 12
Number of Participants Who Adhered to Treatment
Time frame: Day 1 to Week 12
Number of Participants With Use of Rescue Medication in Each Episode
Time frame: Day 1 and Week 12

Results and safety

Results posted to the registry on 20 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mometasone Furoate	385	250

Primary outcome: Forced Expiratory Volume in 1 Second (FEV1)

Time frame: Day 1 and Week 12. Mean (Standard Deviation). Unit: Liters

Measure	Mometasone Furoate n = 250
Initial (Day 1)	2.18 (0.75)
Final (Week 12)	2.6 (0.83)

Population analysed: study completers (per protocol population)

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mometasone Furoate	0 of 281 (0%)	0 of 281 (0%)	Not reported

Limitations and caveats (from the sponsor): Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mometasone Furoate in people with Asthma, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced Expiratory Volume in 1 Second (FEV1) (time frame: Day 1 and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00687531.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.