Health Condition 1: null- Paediatric Patients (6-15 yrs) well controlled mild to moderate asthma
Conditions
Interventions
Intervention1: Aeroguard 4S: Aeroguard 4S (Airpurifier) will be installed in the house of a subject who is randomized to this arm, in the room in which the subject is expected to spend the maximum ti
Sponsors
Eureka Forbes
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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. 6. 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. Parent/guardian of the subject, in the opinion of the investigator, able to understand and comply with the study procedures and willing to sign the ICF.
Exclusion criteria
Exclusion criteria: 1. 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. 4. The subject is currently participating, or has participated in a drug/device study within a period of 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in frequency of short-acting β2-agonist use per week for relief of asthma symptoms from baseline to Day 90. 2. Change in the LFTs (FVC, FEV1, and FEV1/FVC) from baseline to Day 45 and Day 90. 3. Proportion of children requiring modification (increase/decrease) in dose of inhaled corticosteroids at Day 90 from baseline. 4. Proportion of children with mild-moderate, severe, and life-threatening asthma exacerbation (defined as per GINA, 2016) over 90 days between study groups. Timepoint: 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Caregiver-reported outcomes to assess over 90 days. 2. Proportion of children with well-controlled asthma based on C-ACT scoreTimepoint: 90 Days | — |
Countries
India
Contacts
Public ContactPartha Chatterjee
Siro Clinpharm Pvt. Ltd.
Outcome results
None listed