Characteristics and Health Related Quality of Life in Idiopathic Pulmonary Fibrosis
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
high resolution computed tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Idiopathic Pulmonary Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Idiopathic Pulmonary fibrosis will be diagnosed by presence of UIP pattern. Other forms of ILD will be diagnosed using HRCT by presence of Reticular abnormality Honeycombing with or without traction Extensive ground glass abnormality.
- Profuse micronodules.
Exclusion Criteria:
- Patients who refused to participate in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Idiopathic Pulmonary Fibrosis
Arm Description
Idiopathic pulmonary fibrosis patients on high resolution computed tomography characterized by presence of reticular opacities often associated with traction bronchiectasis
Outcomes
Primary Outcome Measures
To compare Health Related Quality of Life in Idiopathic pulmonary fibrosis patients with other forms of interstitial lung disease
St.george respiratory questionnaire
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03171870
Brief Title
Characteristics and Health Related Quality of Life in Idiopathic Pulmonary Fibrosis
Official Title
Clinical, Radiological Characteristics and Health Related Quality of Life in Idiopathic Pulmonary Fibrosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Idiopathic pulmonary fibrosis is defined as a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause, occurring primarily in older adults, limited to the lungs, and associated with the histopathologic and/or radiologic pattern of usual interstitial pneumonia.
The definition of Idiopathic pulmonary fibrosis requires the exclusion of other forms of interstitial pneumonia including other idiopathic interstitial pneumonias and Interstitial lung disease associated with environmental exposure, medication, or systemic disease.
Prevalence estimates for Idiopathic pulmonary fibrosis have varied from 2 to 29 cases per 100,000 in the general population IPF should be considered in all adult patients with unexplained chronic exertional dyspnea, and commonly presents with cough, bibasilar inspiratory crackles, and finger clubbing.
Detailed Description
Idiopathic pulmonary fibrosis should be considered in all adult patients with unexplained chronic exertional dyspnea, and commonly presents with cough, bibasilar inspiratory crackles, and finger clubbing.
High resolution chest computed tomography is an essential component of the diagnostic pathway in Idiopathic pulmonary fibrosis. usual interstitial pneumonia is characterized on high resolution chest computed tomography by the presence of reticular opacities, often associated with traction bronchiectasis.
Patients with interstitial lung disease have poor health-related quality of life. However, whether health-related quality of life differs among different subtypes of interstitial lung disease is unclear.
There is limited research on the health-related quality of life of Idiopathic pulmonary fibrosis patients.
Health-related quality of life deficits should be monitored in clinical practice with Idiopathic pulmonary fibrosis patients and considered when investigating new therapies
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Idiopathic Pulmonary Fibrosis
Arm Type
Other
Arm Description
Idiopathic pulmonary fibrosis patients on high resolution computed tomography characterized by presence of reticular opacities often associated with traction bronchiectasis
Intervention Type
Diagnostic Test
Intervention Name(s)
high resolution computed tomography
Intervention Description
high resolution computed tomography is an essential component of the diagnostic pathway in idiopathic pulmonary fibrosis. Unusual interstitial pneumonia is characterized on high resolution computed tomography by the presence of reticular opacities, often associated with traction bronchiectasis
Primary Outcome Measure Information:
Title
To compare Health Related Quality of Life in Idiopathic pulmonary fibrosis patients with other forms of interstitial lung disease
Description
St.george respiratory questionnaire
Time Frame
10 minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Idiopathic Pulmonary fibrosis will be diagnosed by presence of UIP pattern. Other forms of ILD will be diagnosed using HRCT by presence of Reticular abnormality Honeycombing with or without traction Extensive ground glass abnormality.
Profuse micronodules.
Exclusion Criteria:
Patients who refused to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Souad Sameh
Phone
01025945691
Email
Sss.elsrogy@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maha Ghanen
Organizational Affiliation
Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hoda Makhlouf
Organizational Affiliation
Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ali Hasan
Organizational Affiliation
Assiut University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18086941
Citation
Han MK, McLaughlin VV, Criner GJ, Martinez FJ. Pulmonary diseases and the heart. Circulation. 2007 Dec 18;116(25):2992-3005. doi: 10.1161/CIRCULATIONAHA.106.685206.
Results Reference
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Learn more about this trial
Characteristics and Health Related Quality of Life in Idiopathic Pulmonary Fibrosis
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