| CTRI Number |
CTRI/2018/03/012343 [Registered on: 05/03/2018] Trial Registered Prospectively |
| Last Modified On: |
24/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Airpurifier] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to determine effect of airpurifier - Aeroguard 4S in children suffering from asthma. |
|
Scientific Title of Study
|
A prospective, randomized, open-label, parallel-group study to assess the efficacy and safety of Aeroguard 4S in paediatric asthma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivek Nangia |
| Designation |
Director and Head of Department of Pulmonology |
| Affiliation |
Fortis Flt.Lt.Rajan Dhall Hospital |
| Address |
Fortis Flt.Lt.Rajan Dhall Hospital,
SectorB,Pocket1,Aruna Asaf Ali Marg,
Vasant Kunj, New Delhi
New Delhi
DELHI
110070
India |
| Phone |
9810048850 |
| Fax |
|
| Email |
vivek.nangia@fortishealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Partha Chatterjee |
| Designation |
Head Clinical Research and CTSM |
| Affiliation |
Siro Clinpharm Pvt. Ltd. |
| Address |
Siro Clinpharm Pvt. Ltd.
Kalpataru Prime, 1st Floor,
Unit Nos. 3 and 4, Plot No. D-3,Road No. 16, Wagle Industrial Estate,
Thane (West)-400604, Maharashtra, India
Thane
MAHARASHTRA
400604
India |
| Phone |
9619031696 |
| Fax |
022-61088081 |
| Email |
Partha.chatterjee@siroclinpharm.com |
|
Details of Contact Person
Public Query
|
| Name |
Partha Chatterjee |
| Designation |
Head Clinical Research and CTSM |
| Affiliation |
Siro Clinpharm Pvt. Ltd. |
| Address |
Siro Clinpharm Pvt. Ltd.
Kalpataru Prime, 1st Floor,
Unit Nos. 3 and 4, Plot No. D-3,Road No. 16, Wagle Industrial Estate,
Thane (West)-400604, Maharashtra, India
Thane
MAHARASHTRA
400604
India |
| Phone |
9619031696 |
| Fax |
022-61088081 |
| Email |
Partha.chatterjee@siroclinpharm.com |
|
|
Source of Monetary or Material Support
|
| Eureka Forbes
Eureka Forbes B1/B2, 701, 7th Floor, Marathon Innova, Marathon
NextGen, Off Ganpatrao Kadam Marg, Lower Parel, Mumbai – 400
013, India. |
|
|
Primary Sponsor
|
| Name |
Eureka Forbes |
| Address |
Eureka Forbes
B1/B2, 701, 7th Floor, Marathon Innova, Marathon NextGen, Off Ganpatrao Kadam Marg, Lower Parel, Mumbai – 400 013, India. |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vivek Nangia |
Fortis Flt.Lt.Rajan Dhall Hospital |
Clinical research Room, 5th Floor, Clinical Research Department, Sector B,Pocket 1,Aruna Asaf Ali Marg,
Vasant Kunj, New Delhi
New Delhi
DELHI |
91-9810048850
vivek.nangia@fortishealthcare.com |
| Dr Sandeep Shinde |
P.D.E.A’s Ayurved Rugnalaya & Sterling Multispeciality Hospital |
Room No. 103, OPD, Paediatrics department, Sec No. 27, Near Bhel Chowk, Nigdi Pradhikaran, Pune -411044
Pune
MAHARASHTRA |
91-9822075706
Dr.sandeepshinde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research |
Approved |
| Sterling Hospital Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Paediatric Patients (6-15 yrs) well controlled mild to moderate asthma , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 time, and sleep during the night. Duration of treatment period is 90 days. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
|
90 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Caregiver-reported outcomes to assess over 90 days.
2. Proportion of children with well-controlled asthma based on C-ACT score |
90 Days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
26/03/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |