Health Condition 1: J452- Mild intermittent asthma
Conditions
Interventions
Intervention1: ICS/Formoterol: Budesonide/Formoterol Metered Dose Inhaler (MDI) 200/6µg or 400/12 µg (based on weight), one inhalation for relief of symptoms or whenever required for a period of 3 mon
Sponsors
SRM College of Pharmacy
Eligibility
Inclusion criteria
Inclusion criteria: 1.Newly diagnosed mild to moderate asthma, as per physician’s diagnosis. 2.Has mild or moderate asthma as defined by GINA guidelines or has poor adherence and/or unsatisfactory inhaler technique. 3.Pre-BD FEV1 less than or equal to 50 to 80 percentage predicted for those aged greater than or equal to 18 years. 4.Reversible airway obstruction at screening, defined as an increase in FEV1 greater than or equal to 12 percentage relative to baseline after inhalation of salbutamol. 5.ACQ-7 score greater than or equal to 1.5 at screening and ACQ-5 score of greater than or equal to 1.5 at randomization. 6.BMI less than 40 kg per meter square. 7.Acceptable spirometry performance. 8.Willing and able to give informed consent for participation in the trial.
Exclusion criteria
Exclusion criteria: 1.Self-reported use of ICS, LABA, leukotriene receptor antagonist, theophylline, 4 anticholinergic agents as regular maintenance therapy in the 3 months before potential study entry. Note nasal corticosteroid therapy is permitted. 2.Self-reported past admission to the Intensive Care Unit (ICU) with life-threatening asthma (patients at highest risk of adverse asthma outcomes). 3.Self-reported hospital admission for asthma in the 12 months before potential study entry (patients at highest risk of adverse asthma outcomes). 4.Self-reported treatment with oral prednisone in the six weeks before potential study entry, representing recent unstable asthma. 5.Self-reported diagnosis of COPD, bronchiectasis or interstitial lung disease. 6.Self-reported greater than 20 pack year smoking history, or onset of respiratory symptoms after the age of 40 years in current or ex-smokers with =10 pack year history. 7.Self-reported current pregnancy or breastfeeding at the time of enrolment or planned pregnancy within the study period. 8.Self-reported congestive heart failure, unstable coronary artery disease, atrial fibrillation or other clinically significant cardiac disease. 9.Unwilling or unable to switch from the current asthma treatment regimen. 10.And on treatment FEV1 =50% of predicted at Visit 1 (predicted values must be calculated using the Global Lung Function Initiative equations). 11.Any known or suspected contraindications to the Investigational Medicinal Products or excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Efficacy Measures: oAsthma Control: Measured using the Asthma Control Questionnaire (ACQ) scores. oExacerbations: Number of asthma exacerbations. oTime to First Exacerbation: Duration until the first asthma exacerbation occurs. 2.Safety Measures: oAdverse Events: Frequency and severity of adverse events. oHospitalizations: Incidence of hospitalization due to asthma. Timepoint: Week 0,4,8,12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lung Function: ? Forced Expiratory Volume in One Second (FEV1): Measured during clinic visits. 2. Medication Use: ? Reliever Medication Use: Frequency of as-needed medication use. Timepoint: Week 0,4,8,12. | — |
Countries
India
Contacts
Public ContactKezia Rebecca William
SRM college of Pharmacy
Outcome results
None listed