To test the efficacy of inspiratory muscle training device Airofit in reducing breathlessness in COPD patients

Phase 3

• Conditions: Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified

• Registration Number: CTRI/2021/05/033469
• Lead Sponsor: Airofit AS Copenhagen Denmark

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. All the subjects with spirometry-proven, stable COPD (GOLD stage II and above) will be screened for inclusion.

2.Patients with maximal inspiratory pressure (MIP) less than 100% of predicted will be included

3.Patients with the age between 35 to 65 years will be included in the study

Exclusion Criteria

1. Subjects without access to a suitable smartphone or tablet for the duration of intervention

2. Subjects with an inability to read and understand written and verbal instructions in English

3. Subjects with a history of hospitalization during the previous 4 weeks

4. Subjects with severe orthopedic problems during the previous 4 weeks

5. Subjects with a diagnosed psychiatric or cognitive disorders

6. Subjects with a progressive neurological or neuromuscular disorder

7. Subjects on the waiting list of lung transplantation

8. Subjects with previous inclusion in a rehabilitation program < 1 year

9. Subjects with previous experience of IMT

10. Patients with underlying bronchiectasis, ILC, post-covid, and post tuberculosis sequelae

11. All the COPD patients with active Covid status or within 15 days of post-covid recovery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the ability of Airofit device to provide improvement in the inspiratory muscle strength, assessed using a change in MIP after 12 weeks of home-based IMT intervention in COPD patients.Timepoint: To evaluate the ability of Airofit device to provide improvement in the inspiratory muscle strength, assessed using a change in MIP after 12 weeks of home-based IMT intervention in COPD patients.

Secondary Outcome Measures

Name	Time	Method
To evaluate the ability of the COPD patients to use the Airofit device and a mobile app interface for routine, home-based use as a medical device to improve inspiratory muscle strengthTimepoint: After 4 and 12 weeks of intervention;To evaluate the occurrence of any adverse event (AE) throughout the study period.Timepoint: At the baseline and after intervention of 4 and 12 weeks;To explore the change in MIP after loading the inspiratory muscles using home-based IMT with the Airofit device in comparison to an existing medical device â??POWERbreatheâ??, and a control device â??Breathing pacerâ?? in COPD patients.Timepoint: After 4 and 12 weeks of intervention