A clinical trial to assess the confidence, usability, preference and satisfaction on use of peak flow master 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 peak flow master in healthy volunteers and in subjects with mild Asthma or COPD.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2009/091/000586

Enrollment

Registered

2009-08-04

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

None listed

Interventions

Intervention1: For Obstructive Airway Disease: Peak Flow Master (Device)for measuring Airway Obstruction of Lungs Control Intervention1: NIL: NIL

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. 5.Subjects who are only English speaking

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Average time taken for three consecutive correct attempts during the first and second visit.Timepoint: Between visit-1 and visit-2	—

Secondary

Measure	Time frame
Confidence assessmentTimepoint: Between Visit-1 and Visit-2;Preference assessmentTimepoint: Between Visit-1 and Visit-2;Satisfaction assessmentTimepoint: Between Visit-1 and Visit-2;Type and number of errors during first and second visit.Timepoint: Between Visit-1 and Visit-2;Usability assessmentTimepoint: Between Visit-1 and Visit-2	—

Countries

India

Contacts

Public ContactDr Sundeep Salvi

jgogtay@cipla.com022-23025412

Outcome results