The Real World Effectiveness of Single Inhaler Triple Treatment through Assorted Respiratory Outcomes when Switched from Multiple Inhaler Triple Therapies (RESTART study)
Not Applicable
Recruiting
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0007752
- Lead Sponsor
- Gyeongsang National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 107
Inclusion Criteria
. Patients older than 40 years of age
-. Diagnosed with Chronic obstructive pulmonary disease
-. Agree with Participating Research
-. Treated by MITT(Multiple Inhaler Triple Treatment),(>=90days)
Exclusion Criteria
- a potentially pregnant patient
- Patients who are likely to die within 6 months or have poor health.
- Patients with unstable COPD with exacerbation within 4 weeks.
- Patients with other illnesses or mental illnesses.
- Patients who are hypersensitive to steroids and anti-choline, muscarinic drugs, and lactose/lactose proteins.
- Patients who use oral steroids for a long period of time (over 4 weeks) due to diseases other than COPD.
- Patients currently participating in interventional clinical research.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline of CAT Score
- Secondary Outcome Measures
Name Time Method Change from baseline of FEV1;Over 2 point improved from baseline of CAT Score;Comparison of CAT Score improvements of more than 2 points for patients using the Elipta Device compared to patients who did not use the previous Elipta Device;Comparison of FEV1 improvements for patients using the Elipta Device compared to patients who did not use the previous Elipta Device; Clinically Important Deterioration (FEV1, Exacerbation, CAT);Comparison of FEV1 improvements for patients using the Elipta Device compared to patients who did not use the previous Elipta Device;Change from Baseline of mMRC;Over 1point improvement of baseline on mMRC;Change from baseline of TS-VAS;Exacerbation rate in 1 year