Skip to content

A clinical trial to assess the confidence, usability, preference and satisfaction on use of Dry Powder Inhaler (DPI) in healthy volunteers and in subjects with mild asthma or COPD.

An open, prospective, multicentre study to assess the confidence, usability, preference and satisfaction on use of Revolizer 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/2009/091/000215
Enrollment
100
Registered
2009-06-08
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 in subjects with mild Asthma or COPD

Interventions

Intervention1: Revolizer (Dry Powder Inhaler): Investigational Device: Revolizer with placebo rotacaps. Usage of placebo rotacap was depend upon the number of attempts required by the subject. Control

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 inhaler) should be matched as far as possible with an individual without a respiratory condition (inhaler naïve) with respect to the age, sex, literacy status etc 4. Subjects with mild Asthma or COPD

Exclusion criteria

Exclusion criteria: 1. Subjects already using Dry Powder Inhaler (DPI) prior to start of the study. 2. Subjects with co-ordination problems like Parkinson?s disease, mental illness, tremors etc.

Design outcomes

Primary

MeasureTime frame
Average time taken for three consecutive correct attempts during the first and second visit.Timepoint: First and Second Visit

Secondary

MeasureTime frame
1.Type and number of errors during first and second visit. 2.Confidence assessment 3.Usability assessment 4.Preference assessment and 5.Satisfaction assessmentTimepoint: First and Second Visit

Countries

India

Contacts

Public ContactDr Pramod Niphadkar

Cipla Ltd.

jgogtay@cipla.com022-23025412

Outcome results

None listed

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