Efficacy of Aerobika

JRCT ID: jRCT1032180010

Registered date:09/07/2018

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Chronic Obstructive Pulmonary Disease; COPD
• Date of first enrollment: 01/07/2018
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Treatment with Aerobika.

Outcome(s)

• Primary Outcome: Change in FEV1 before and after 4-week treatment with Aerobika.

Secondary Outcome

Following parameters will be assessed for before and at 4-week treatment with Aerobika.
1. VC, FVC, V50, and V25
2. IOS (R5, R5ins, R5exp, R20, X5, X5ins, X5exp, Fres, Ax)
3. 6 minute-walking test
4. CAT score, mMRC
5. Acute exacerbation

Key inclusion & exclusion criteria

• Age minimum: none
• Age maximum: none
• Gender: Both

Include criteria

Subject has post-long acting bronchodilator forced expiratory volume in first second (FEV1) is less than 80% predicted.
Subject has declared that he/she has stopped smoking for at least 8 weeks prior to entering the study.
Subject has respiratory symptoms 10 and over on the CAT total score, and has the phlegm symptoms 2 and over on the CAT phlegm score.
Subject has read, understood, and signed the informed consent form.

• Exclude criteria: The condition that the investigator judges to exclude from the study.

Related Information

• Primary Sponsor: Mineshita Masamichi