A study to evaluate ease of use and participants perception with breathe activated inhaler in comparison of pressurized meter dose inhaler in patients with Asthma or COPD and Healthy Volunteer.

An open label, prospective, comparative, multicentre, 2 weeks study to assess the device handling, human factors, ease of use, errors and participant perception on use of a breath actuated inhaler versus pressurized metered dose inhaler in healthy volunteers and in patients with Asthma or COPD.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2015/08/006092

Enrollment

460

Registered

2015-08-13

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- Patients with Asthma or COPD with no major other illness

Interventions

Intervention1: Placebo breath actuated inhaler: Twice daily over and above regular medication Control Intervention1: Placebo pressurized meter dose inhaler: Twice daily over and above regular medicati

Eligibility

Inclusion criteria

Inclusion criteria: 1. A written signed dated informed consent from all participants before study procedures. 2. Participants of both genders either healthy or confirmed diagnosis with Asthma (updated GINA 2015) aged between 5 and 80 years or confirmed diagnosis with COPD (updated GOLD 2015)aged between 40 to 80 years. 3. Patients using only pMDI device over past 3 months.

Exclusion criteria

Exclusion criteria: 1. Current or past users of breath actuated inhaler

Design outcomes

Primary

Measure	Time frame
Percentage of participants who used breath actuated inhaler without errors after reading the patients information leaflet.Timepoint: Assessed at Visit 1	—

Secondary

Measure	Time frame
Average time and number of training sessions required to perform the inhalation technique correctly during the first and second visit for both the devicesTimepoint: Assessed at Visit 1 and Visit 2;Device handling questionnaire and ease of use questionnaireTimepoint: Assessed at Visit 2;Number of errors during each training session until the participants are able to perform the inhalation technique correctly for both the devicesTimepoint: Assessed at Visit 1 and Visit 2;Number of errors during first visit without training for both the inhalers.Timepoint: Assessed at Visit 1;Percentage of participants having overall preference for breath actuated inhaler over pressurised meter dose inhaler at the end of 14 days useTimepoint: Assessed at Visit 2	—

Measure

Time frame

Average time and number of training sessions required to perform the inhalation technique correctly during the first and second visit for both the devicesTimepoint: Assessed at Visit 1 and Visit 2;Device handling questionnaire and ease of use questionnaireTimepoint: Assessed at Visit 2;Number of errors during each training session until the participants are able to perform the inhalation technique correctly for both the devicesTimepoint: Assessed at Visit 1 and Visit 2;Number of errors during first visit without training for both the inhalers.Timepoint: Assessed at Visit 1;Percentage of participants having overall preference for breath actuated inhaler over pressurised meter dose inhaler at the end of 14 days useTimepoint: Assessed at Visit 2

—

Countries

India

Contacts

Public ContactAbhijit Vaidya

Cipla Ltd

abhijit.vaidya@cipla.com022-24814735

Outcome results

None listed

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