Trial Outcomes & Findings for Clinical Trial to Assess Efficacy, Safety, Treatment Adherence and Quality of Life Impact of Mometasone Furoate in Asthmatic Patients (Study P04879)(TERMINATED) (NCT NCT00687531)
NCT ID: NCT00687531
Last Updated: 2024-05-24
Results Overview
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.
TERMINATED
PHASE4
385 participants
Day 1 and Week 12
2024-05-24
Participant Flow
Participant milestones
| Measure |
Mometasone Furoate
Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
385
|
|
Overall Study
RECEIVED TREATMENT
|
281
|
|
Overall Study
COMPLETED
|
250
|
|
Overall Study
NOT COMPLETED
|
135
|
Reasons for withdrawal
| Measure |
Mometasone Furoate
Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
|
|---|---|
|
Overall Study
Did not meet protocol eligibility
|
104
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Lost to Follow-up
|
26
|
Baseline Characteristics
Clinical Trial to Assess Efficacy, Safety, Treatment Adherence and Quality of Life Impact of Mometasone Furoate in Asthmatic Patients (Study P04879)(TERMINATED)
Baseline characteristics by cohort
| Measure |
Mometasone Furoate
n=281 Participants
Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
|
|---|---|
|
Age, Customized
Between 21 and 30 years
|
54 participants
n=5 Participants
|
|
Age, Customized
Between 31 and 40 years
|
40 participants
n=5 Participants
|
|
Age, Customized
Between 41 and 50 years
|
58 participants
n=5 Participants
|
|
Age, Customized
Between 51 and 60 years
|
64 participants
n=5 Participants
|
|
Age, Customized
Between 61 and 70 years
|
39 participants
n=5 Participants
|
|
Age, Customized
Between 71 and 80 years
|
17 participants
n=5 Participants
|
|
Age, Customized
Between 81 and 90 years
|
6 participants
n=5 Participants
|
|
Age, Customized
Not Available to Report
|
3 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
199 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
81 participants
n=5 Participants
|
|
Sex/Gender, Customized
Not Available to Report
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Week 12Population: study completers (per protocol population)
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.
Outcome measures
| Measure |
Mometasone Furoate
n=250 Participants
Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
|
|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1)
Initial (Day 1)
|
2.18 Liters
Standard Deviation 0.75
|
|
Forced Expiratory Volume in 1 Second (FEV1)
Final (Week 12)
|
2.6 Liters
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Day 1 and Week 12Population: study completers (per protocol population)
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.
Outcome measures
| Measure |
Mometasone Furoate
n=250 Participants
Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
|
|---|---|
|
Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR)
Initial AM (Day 1)
|
313.3 Liters/minute
Standard Deviation 111.2
|
|
Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR)
Initial PM (Day 1)
|
311.12 Liters/minute
Standard Deviation 111.2
|
|
Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR)
Final AM (Week 12)
|
393.3 Liters/minute
Standard Deviation 144.59
|
|
Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR)
Final PM (Week 12)
|
395.09 Liters/minute
Standard Deviation 144.59
|
SECONDARY outcome
Timeframe: Day 1 and Week 12Population: study completers (per protocol population)
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.
Outcome measures
| Measure |
Mometasone Furoate
n=44 questions
Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
|
|---|---|
|
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
|
41 questions
|
SECONDARY outcome
Timeframe: Day 1 and Week 12Population: This analysis was not performed due to missing data at the sites.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 and Week 12Population: This analysis was not performed due to missing data at the sites.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 and Week 12Population: This analysis was not performed due to missing data at the sites.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: This analysis was not performed due to missing data at the sites.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: This analysis was not performed due to missing data at the sites.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 and Week 12Population: This analysis was not performed due to missing data at the sites.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to Week 12Population: study completers (per protocol population)
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.
Outcome measures
| Measure |
Mometasone Furoate
n=250 Participants
Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
|
|---|---|
|
Number of Participants Who Adhered to Treatment
Twisthaler reading 0 (zero)
|
196 participants
|
|
Number of Participants Who Adhered to Treatment
Twisthaler reading above zero
|
29 participants
|
|
Number of Participants Who Adhered to Treatment
Not specified
|
25 participants
|
SECONDARY outcome
Timeframe: Day 1 and Week 12Population: This analysis was not performed due to missing data at the sites.
Outcome measures
Outcome data not reported
Adverse Events
Mometasone Furoate
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee 30 days written notice is required prior to submission of study results for publication/presentation so that Sponsor can review the material to be submitted. Sponsor has the right to review/comment on the material \& if the parties have any disagreement concerning the appropriateness of the material, the PI and Sponsor must meet to discuss/resolve any issues/disagreement prior to submission. Interim results of the Study may not be published/presented without prior written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER