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Study to assess the confidence, usability, preference and satisfaction on use of Zerostat-V 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 satisfaction on use of Zerostat V 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/2014/03/004462
Enrollment
30
Registered
2014-03-10
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- Healthy volunteers and subjects with mild Asthma or COPD.

Interventions

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

Sponsors

Cipla Ltd
Lead Sponsor

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 naïve) 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-V spacer prior to start of the study. 2. Subjects with co-ordination problems like Parkinsonâ??s disease, mental illness, tremors etc.

Design outcomes

Primary

MeasureTime frame
Average time taken for 3 consecutive correct attemptsTimepoint: Average time taken for 3 consecutive correct attempts

Secondary

MeasureTime frame
Confidence, Usability, Preference, Satisfaction assessment.Timepoint: Throughout the study;Type and number of errorsTimepoint: 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