A prospective, randomized, open-label, parallel-group study to assess the efficacy and safety of Aeroguard 4S in paediatric asthma

Eureka Forbes0 个研究点目标入组 27 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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.

发起方

Eureka Forbes