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Clinical Trials/ISRCTN13784514
ISRCTN13784514
Completed
未知

A feasibility, randomised controlled trial of a complex breathlessness intervention in idiopathic pulmonary fibrosis (BREEZE-IPF)

Hull and East Yorkshire Hospitals NHS Trust0 sites50 target enrollmentJuly 5, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
Idiopathic pulmonary fibrosis
Sponsor
Hull and East Yorkshire Hospitals NHS Trust
Enrollment
50
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

2019 protocol in https://pubmed.ncbi.nlm.nih.gov/31649946/ (added 01/06/2021)

Registry
who.int
Start Date
July 5, 2018
End Date
May 31, 2020
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Hull and East Yorkshire Hospitals NHS Trust

Eligibility Criteria

Inclusion Criteria

  • 1\. Males and females aged \=50 years. This age cut\-off is chosen because IPF is very rare under 50 years of age making an alternative diagnosis likely
  • 2\. IPF diagnosed by multidisciplinary team (MDT) consensus in accordance with international guidelines
  • 3\. mMRC dyspnoea grades 3 or 4 despite optimal management
  • 4\. Oxygen saturation \=90% on air/using usual oxygen prescription
  • 5\. Able to give informed consent

Exclusion Criteria

  • 1\. Significant comorbid cardiorespiratory disease other than IPF considered by the principal investigator to be the primary cause of breathlessness
  • 2\. Pulmonary rehabilitation: completed \< \= 3 months previously
  • 3\. Breathlessness clinic attendance: completed \< \= 3 months previously
  • 4\. Unwilling or unable to consent or complete study measures

Outcomes

Primary Outcomes

Not specified

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