A study to determine effect of airpurifier - Aeroguard 4S in children suffering from asthma.
- Conditions
- Paediatric Patients (6-15 yrs) well controlled mild to moderate asthma
- Registration Number
- CTRI/2018/03/012343
- Lead Sponsor
- Eureka Forbes
- Brief Summary
This is a prospective, randomized, open-label, parallel-group study to assess the efficacy and safety of Aeroguard 4S in paediatric asthma.
The study will be conducted in approximately 64 subjects, between 6-15 years of age (extremes included), with well controlled mild to moderate asthma as per GINA, 2016.
In order to assess the efficacy of Aeroguard 4S in reducing asthma symptoms, subjects in both the test and control arms will be monitored for asthma symptom control, lung function tests (LFTs), asthma exacerbations, and use of reliever and controller asthma medications.
Safety of the Aeroguard 4S will also be evaluated. Any AE experienced by the subjects during the 90-day study period will be recorded, assessed, reported, and followed-up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 64
- Children (boy or girl), 6-15 years of age (both inclusive); 2.
- Diagnosed with mild to moderate asthma, as per GINA, 2016, at least 1 year prior to the screening visit (See Appendix 1 for definition of mild to moderate asthma, as per GINA, 2016); 3.
- Well-controlled on current asthma medication at least 1 month prior to screening; 4.
- Resides within the geographical area of the study site so that home visits for installation, repair, and uninstallation of Aeroguard 4S are feasible; 5.
- Sleeps/spends at least approximately 8 hours per day for at least 5 days per week in a room in which the Aeroguard 4S is proposed to be installed.
- Have no plans to relocate from the current residential accommodation in the next 3-4 months; 7.
- Has uninterrupted power supply to ensure continuous working of Aeroguard 4S; 8.
- Subject ≥7 years of age able to understand and comply with the study procedures (in the opinion of the investigator), and willing to sign the Assent Form; 9.
- Subject has lung disease other than asthma, as noted on history or chest x-ray performed at screening, if required; 2.
- Subject has any condition (including history or presence of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic, rheumatologic, psychiatric, metabolic disturbances, or any other significant medical condition) that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit or confound the protocol-specified assessments; 3.
- Subject has a functioning air purifier already installed at home.
- The subject is currently participating, or has participated in a drug/device study within a period of 30 days prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in frequency of short-acting β2-agonist use per week for relief of asthma symptoms from baseline to Day 90. 90 days 2. Change in the LFTs (FVC, FEV1, and FEV1/FVC) from baseline to Day 45 and Day 90. 90 days 3. Proportion of children requiring modification (increase/decrease) in dose of inhaled corticosteroids at Day 90 from baseline. 90 days 4. Proportion of children with mild-moderate, severe, and life-threatening asthma exacerbation (defined as per GINA, 2016) over 90 days between study groups. 90 days
- Secondary Outcome Measures
Name Time Method 1. Caregiver-reported outcomes to assess over 90 days. 2. Proportion of children with well-controlled asthma based on C-ACT score
Trial Locations
- Locations (2)
Fortis Flt.Lt.Rajan Dhall Hospital
🇮🇳Delhi, DELHI, India
P.D.E.A’s Ayurved Rugnalaya & Sterling Multispeciality Hospital
🇮🇳Pune, MAHARASHTRA, India
Fortis Flt.Lt.Rajan Dhall Hospital🇮🇳Delhi, DELHI, IndiaDr Vivek NangiaPrincipal investigator91-9810048850vivek.nangia@fortishealthcare.com