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The Real World Effectiveness of Single Inhaler Triple Treatment through Assorted Respiratory Outcomes when Switched from Multiple Inhaler Triple Therapies (RESTART study)

The Real World Effectiveness of Single Inhaler Triple Treatment through Assorted Respiratory Outcomes when Switched from Multiple Inhaler Triple Therapies (RESTART study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0007752
Enrollment
107
Registered
2022-09-29
Start date
2022-06-22
Completion date
Unknown
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Gyeongsang National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Change from baseline of CAT Score

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactLim hana

Sungkyunkwan University

lhn4416@gmail.com+82-2-000-0000

Outcome results

None listed

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