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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 26, 2017
    Last Updated
    May 30, 2017
    Sponsor
    Assiut University
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    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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    Characteristics and Health Related Quality of Life in Idiopathic Pulmonary Fibrosis

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