Status:
RECRUITING
Study of Patient With Frequent COPD Exacerbations
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
18-100 years
Brief Summary
This Study is a multicenter, non-interventional, observational, ambispective (retrospective-prospective) study to evaluate clinical and demographic characteristics, approaches to therapy in outpatient...
Detailed Description
The study consists of a retrospective phase covering 52 weeks and a prospective phase of 24 weeks, involving 2000 patients across approximately 35 cites. Therefore, the aim of the study is to evaluate...
Eligibility Criteria
Inclusion
- Age ≥ 18 years at the time of inclusion;
- Signed and dated written informed consent in accordance with ICH-GCP and local law prior to inclusion in the study;
- Patients with diagnosed moderate-to-severe COPD (see comments below);
- ≥2 moderate or ≥1 severe COPD exacerbations in previous 52 weeks (see comments below);
- Patients have been receiving two inhaled maintenance therapies (LABA/LAMA, ICS/LABA, ICS/LAMA) for at least 6 weeks prior to inclusion.
Exclusion
- Current or previous treatment with triple combination (ICS/LABA/LAMA) within 52 weeks prior to inclusion;
- COPD due to documented α-1 antitrypsin deficiency;
- A diagnosis of bronchiectasis, sarcoidosis, interstitial lung diseases, or idiopathic pulmonary fibrosis, exacerbation of bronchial asthma or any acute or chronic disease that, as deemed by Investigator, limits the ability of patients to participate in this study or could influence the interpretation of the results;
- The participation in any clinical study currently or within 52 weeks prior to inclusion.
Key Trial Info
Start Date :
December 16 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT07221981
Start Date
December 16 2024
End Date
June 30 2026
Last Update
December 1 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Research site
Ivanovo, Russia
2
Research site
Moscow, Russia
3
Research site "OOO Energy of health"
Saint Petersburg, Russia
4
Research site
Saint Petersburg, Russia