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A Study to Understand Comfort and Ease of Use Of A Novel Spacer Device when Connected with Inhalers in Participants with Asthma and COPD (Chronic Obstructive Pulmonary Disease)

Acceptability and Usability of the A202 Spacer Device as an add on with pressurized Metered Dose Inhaler (pMDI) in Patients with Asthma and COPD - NIL

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092275
Enrollment
50
Registered
2025-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 2: J454- Moderate persistent asthma Health Condition 3: J453- Mild persistent asthma

Interventions

Intervention1: A202 Compact Spacer Device: The compact spacer device will be kept attached to metered dose inhaler for 8 weeks and the usability will be assessed. Control Intervention1: NA: NA

Sponsors

AeroDel Technology Innovations Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: For Asthma Adults aged 18 to 65 years For COPD 40 to 65 years age Participants willing to participate in the study Participants who are already using metered dose inhaler with spacer brands available in the market

Exclusion criteria

Exclusion criteria: Pregnant women and breastfeeding mothers Patients admitted with acute exacerbation of asthma or COPD Patients who are on nebulized medications Participants who have psychiatric illness or any other severe comorbid illness which may preclude participation in study Participants with an underlying end stage lung disease

Design outcomes

Secondary

MeasureTime frame
Compliance to metered dose inhaler with attached spacerTimepoint: Week 2 week 4 week 6 week 8

Primary

MeasureTime frame
Patient comfort in using the device will be assessed based on responses to a structured questionnaireTimepoint: Patient comfort in using the device will be assessed fortnightly at 2nd, 4th, 6th and 8th week.

Countries

India

Contacts

Public ContactDr Uma Maheswari K

St Johns Medical College

uma.mk@stjohns.in9483702412

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026