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Clinical Trials/ISRCTN16377955
ISRCTN16377955
Active, not recruiting
未知

Curbing High Risk of Non-obstructive smokers

niversity Hospital of Basel0 sites158 target enrollmentAugust 18, 2022

Overview

Phase
未知
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease GOLD 0 is defined as patients with normal spirometry but with chronic symptoms such as cough and/or sputum production.
Sponsor
niversity Hospital of Basel
Enrollment
158
Status
Active, not recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 18, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity Hospital of Basel

Eligibility Criteria

Inclusion Criteria

  • Both groups:
  • 1\. Able to give informed consent as documented by signature
  • 2\. Age \=40 years
  • 3\. FEV1/FVC \=0\.70
  • Intervention group: Current or past smokers
  • 4\. \=10 pack years
  • 5\. At least one symptom from the following: (Cough, Phlegm, Shortness of breath)
  • Control group: Minimal smoking exposure
  • 6\. \=1 pack year tobacco\-smoking history

Exclusion Criteria

  • Both groups:
  • 1\. Pregnant or lactating women
  • 2\. Current increased (more than usual) respiratory symptoms
  • 3\. Concomitant respiratory disease (eg asthma, ILD) or clinically significant bronchiectasis
  • 4\. Unstable cardiovascular disease
  • 5\. Inability to follow the procedures of the study, e.g. due to language problems, dementia, etc.
  • 6\. Active pulmonary infection or prior pulmonary infection where antibiotic and/or steroid treatment was completed \=4 weeks prior to enrolment
  • 7\. Enrolment in an interventional clinical trial within last 30 days
  • 8\. Severe immunosuppression including manifested AIDS, organ transplantation, ongoing chemotherapy for cancer or neutropenia (\<500\*10^9/L)
  • 9\. Chronic use of oral steroids (\>10 mg per day)

Outcomes

Primary Outcomes

Not specified

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