Study to assess the confidence, usability, preference and satisfaction on use of Zerostat-VT Spacer in healthy volunteers and in subjects with mild asthama or COPD

An open, prospective, single centre study to assess the confidence, usability, preference and satisfaction on use of Zerostat-VT Spacer in healthy volunteers and in subjects with mild asthama or COPD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/02/004432

Enrollment

Registered

2014-02-25

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

Interventions

Intervention1: Zerostat VT spacer with Placebo pMDI: Placebo pMDI (Pressurized Metered Dose Inhaler) with Zerostat-VT spacer device used for 3 consecutive inhalation attempts Intervention2: Zerostat-V

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects and healthy volunteers willing to sign ethics committee approved informed consent form. 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 a device) should be matched as far as possible with an individual without a respiratory condition (device naive) 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-VT 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 attempts Timepoint: During First and second visit	—

Secondary

Measure	Time frame
Confidence, Usability, Preference, Satisfaction assessmentTimepoint: Throughout the study;Number of attempts required to achieve first correct attemptTimepoint: At baseline and follow-up visit;Type and number of errorsTimepoint: During first and second visit	—

Countries

India

Contacts

Public ContactMs Pallavi Phopale

Cipla Ltd.

jgogtay@cipla.com022-23025412

Outcome results

None listed

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