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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
385
Mometasone Furoate 400 mcg once daily, in the evening through 12 weeks.
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.
Time frame: Day 1 and Week 12
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.
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
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.
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).
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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
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