Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mometasone Furoate | Experimental | Mometasone Furoate 400 mcg once daily in the evening through 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone Furoate | Drug | Mometasone Furoate 400 mcg once daily, in the evening through 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mometasone Furoate | Mometasone Furoate 400 mcg once daily in the evening through 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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 |
| 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). | 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). | 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. | 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. | Day 1 to Week 12 |
| Number of Participants With Use of Rescue Medication in Each Episode | Day 1 and Week 12 |
| RECEIVED TREATMENT |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mometasone Furoate | Mometasone Furoate 400 mcg once daily in the evening through 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex/Gender, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | study completers (per protocol population) | Posted | Mean | Standard Deviation | Liters | Day 1 and Week 12 |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | study completers (per protocol population) | Posted | Mean | Standard Deviation | Liters/minute | Day 1 and Week 12 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | study completers (per protocol population) | Posted | Number | questions | Day 1 and Week 12 | questions | questions |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | This analysis was not performed due to missing data at the sites. | Posted | Day 1 and Week 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Nocturnal Awakenings | This analysis was not performed due to missing data at the sites. | Posted | Day 1 and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Puffs of Salbutamol Used Daily | This analysis was not performed due to missing data at the sites. | Posted | Day 1 and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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). | This analysis was not performed due to missing data at the sites. | Posted | Baseline, Week 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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). | This analysis was not performed due to missing data at the sites. | Posted | Baseline, Week 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | This analysis was not performed due to missing data at the sites. | Posted | Day 1 and Week 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | study completers (per protocol population) | Posted | Number | participants | Day 1 to Week 12 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Use of Rescue Medication in Each Episode | This analysis was not performed due to missing data at the sites. | Posted | Day 1 and Week 12 | episodes | episodes |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mometasone Furoate | Mometasone Furoate 400 mcg once daily in the evening through 12 weeks. | 0 | 281 | 0 | 281 |
Not provided
Not provided
Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Between 51 and 60 years |
|
| Between 61 and 70 years |
|
| Between 71 and 80 years |
|
| Between 81 and 90 years |
|
| Not Available to Report |
|
| Not Available to Report |
|
|
| questions |
|
|
|