A three-arm, randomized, triple-blind, non-inferiority, Phase III clinical trial to test the efficacy of the experimental device â??Airofitâ?? in improving inspiratory muscle strength, compared to a comparator device â??POWERbreatheTMâ?? and a control device â??breathing pacerâ?? in patients with COPD. - Airofit IMT

Airofit AS Copenhagen Denmark0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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

•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

发起方

Airofit AS Copenhagen Denmark