Clinical Trial to Assess Efficacy, Safety, Treatment Adherence and Quality of Life Impact of Mometasone Furoate in Asthmatic Patients (Study P04879)(TERMINATED) (APEGO)
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- 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.
- Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR) [ Time Frame: Day 1 and Week 12 ]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.
- 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 ]
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.
- 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 ]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.
- 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 ]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).
- Patient's Assessment of Response to Therapy Based on a 5-point Scale [ Time Frame: Baseline, Week 12 ]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).
- Number of Participants With One or More Mild, Moderate or Severe Asthma Exacerbations [ Time Frame: Day 1 and Week 12 ]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.
- Number of Participants Who Adhered to Treatment [ Time Frame: Day 1 to Week 12 ]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.
- Number of Participants With Use of Rescue Medication in Each Episode [ Time Frame: Day 1 and Week 12 ]
|Study Start Date:||November 2006|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Experimental: Mometasone Furoate
Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
Drug: Mometasone Furoate
Mometasone Furoate 400 mcg once daily, in the evening through 12 weeks.
Other Name: SCH 32088