STudying Acute exaceRbations and Responses: COPD STARR Study. v1.0

Not Applicable

Completed

• Conditions: Topic: Primary Care; Subtopic: Primary care; Disease: All Diseases; Not Applicable

• Registration Number: ISRCTN90445176
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-20
• Study Completion: 2017-12-31
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Male or female, aged 40 years or above.
3. Known diagnosis of COPD (either diagnosis made in primary or secondary care) as per national and international guidelines (NICE, 2010 & GOLD 2013), irrespective of severity
4. Current or ex-smoker
5. Smoking pack year history >10
6. Spirometry confirming fixed airflow obstruction (FEV1/FVC ratio <0.7)

Target Gender: Male & Female; Lower Age Limit 40 years

Exclusion Criteria

1. History of atopic childhood asthma
2. Current history of primary lung malignancy or current active pulmonary TB
3. Upon questioning the participant is HIV, hepatitis B or C positive
4. Clinically relevant disease or disorder (past or present) which in the opinion of the investigator may either put the subject at risk because of participating in the study or may influence the results of the study or the subject’s ability to participate in the study
5. Any clinically relevant lung disease other than COPD, considered by the investigator to be the primary diagnosis. For example mild to moderate bronchiectasis is acceptable in addition to COPD unless the bronchiectasis is considered to be the primary diagnosis
6. An alternative cause for the increase in symptoms of COPD that are unrelated to an exacerbation such as
6.1. Suspicion or clinical evidence of pneumonia
6.2. High probability and suspicion of pulmonary embolism
6.3. Suspicion or clinical evidence of a pneumothorax
6.4. Primary ischaemic event – ST or non ST elevation myocardial infarct and left ventricular failure (i.e., not an exacerbation of COPD)

Study & Design

• Study Type: Observational
• Study Design: Not specified