Study to assess the confidence, usability, preference and satisfaction on use of Zerostat spacer in healthy volunteers and in subjects with mild Asthma or COPD.

An open, prospective, single centre study to assess the confidence, Usability, preference and satisfation on use of Zerostat Spacer in healthy Volunteers and in subjects with mild asthma or COPD.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/03/004448

Enrollment

Registered

2014-03-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Subjects with mild Asthma or COPD or healthy volunteer.

Interventions

Intervention1: Zerostat spacer with Placebo pMDI: Placebo pMDI (Pressurized metered-dose inhaler) with Zerostat spacer device used for 3 consecutive inhalation attempts Control Intervention1: Not Appl

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects and healthy volunteers willing to sign informed consent 2. Subjects and healthy volunteers of 18 years and above 3. Subjects with or without a respiratory condition. Each subject with a respiratory condition (prior experience of using an device) should be matched as far as possible with an individual without a respiratory condition (device naÃ¯ve) with respect to the age, sex, literacy status etc 4. Subjects with mild Asthma or COPD or healthy volunteer.

Exclusion criteria

Exclusion criteria: 1. Subjects already using Zerostat spacer prior to start of the study. 2. Subjects with co-ordination problems like Parkinsonâ??s disease, mental illness, tremors etc.

Design outcomes

Primary

Measure	Time frame
Average time taken for 3 consecutive correct attemptTimepoint: Average time taken for 3 consecutive correct attempt	—

Secondary

Measure	Time frame
Confidence, Usability, Preference and Satisfaction assessmentTimepoint: Throughout the study period;Type and number of errorsTimepoint: During first and second visit	—

Countries

India

Contacts

Public ContactMs Pallavi Phopale

Sponsorâ??s Representative

jgogtay@cipla.com022-23025412

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026