Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 225 for:    Bronchiectasis

Different Phenotypes of Bronchiectasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03262064
Recruitment Status : Terminated (Changing of specialty)
First Posted : August 25, 2017
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Samah Mohammad Hussein, Assiut University

Brief Summary:
Bronchiectasis is defined as abnormal chronic dilatation of one or more bronchi. Patients have a structural abnormality of the bronchial wall that predisposes them to bacterial infection likely due to impaired mucus clearance. A vicious cycle of chest infections and chronic lung inflammation can lead to further damage of the bronchial wall and spread of disease to normal areas of bystander lung.

Condition or disease Intervention/treatment
Bronchiectasis Combination Product: Pulmonary function tests,Bronchiectasis severity index score

Detailed Description:

A search for an underlying cause, which may be amenable to a targeted intervention to prevent ongoing damage, is essential but often fruitless, and the focus of therapy rapidly turns to empiric treatments to prevent infective exacerbations and retard disease progression. The British Thoracic Society Bronchiectasis management guidelines provide an in-depth summary of the available literature and are an excellent tool for guiding treatment decision making. However, they do not provide guidance on which patients are most likely to benefit from specific interventions.Disease severity in bronchiectasis is hard to define. Radiological severity grading scores exist; however, there is often a disconnect between radiological severity, symptom burden and disease progressionIn 2014, competing bronchiectasis severity scores were published (FACED and the Bronchiectasis Severity Index (BSI).

In each of these, a combination of patient demographics, symptom scores, comorbidities, and clinical, radiological and microbiological parameters were used to construct scoring systems.

In case of the BSI, it predicted future mortality, and in the case of FACED, extended to prediction of future exacerbation frequency, hospitalisation and quality of life.These severity scores have utility in identifying an individual's risk of disease progression to a predefined outcome and aid in sub classifying this heterogeneous group of patients in a manner that may pave the way to future mechanistic studies, which explain how these different disease phenotypes arise and inform the development of targeted therapeutics.


Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Different Phenotypes of Bronchiectasis
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : January 1, 2019

Intervention Details:
  • Combination Product: Pulmonary function tests,Bronchiectasis severity index score

    Pulmonary function tests: including spirometry, DLCO, and lung volumes. Sputum investigations: The following investigations will be performed on fresh sputum samples; gram stains and culture, smear and culture for mycobacteria and fungi and antibiotic sensitivity tests Bronchoscopy: Bronchoscopy with bronchoalveolar lavage will be used to obtain specimens for staining and culture to identify type of colonization.

    Radiology: All patients will have a chest radiograph (PA and lateral) and high-resolution computed tomography (HRCT) scan.

    Bronchiectasis severity index score parameters FACED Score



Primary Outcome Measures :
  1. ( Severity of Bronchiectasis will be measured according to BSI scoring system and FACED scoring system [ Time Frame: Baseline ]

    BSI (Bronchiectasis severity index) score parameters include: Age, Body mass index, %FEV1 predicted, Previous Hospital admissions, Number of exacerbations in previous year, MRC dyspnea scale, Pseudomonas colonization, colonization with other organisms and radiological severity.

    Scoring:

    0-4 points Mild bronchiectasis 5-8points Moderate bronchiectasis 9+ points Severe bronchiectasis FACED score F - FEV1 A - Age C - Chronic colonization E - Radiological Extension D - Dyspnea

    Scoring:

    0-2 points Mild bronchiectasis 3-4 points Moderate bronchiectasis 5-7 points Severe bronchiectasis



Secondary Outcome Measures :
  1. management of bronchectasis according to severity index [ Time Frame: Baseline ]
    we will modify treatment of bronchectasis according to different phenotypes of bronchiectasis and severity score.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
all patients (age >18and <70 years old) who will be presented to Assuit Chest Department from August 2017 till August 2018 and diagnosed as bronchiectasis according to clinical picture and high- resolution computed tomography scan of the chest.
Criteria

Inclusion Criteria:

patient diagnosed as bronchiectasis according to clinical picture and high- resolution computed tomography scan of the chest.

can perform pulmonary function test.

Exclusion Criteria:

No


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262064


Locations
Layout table for location information
Egypt
Assiut University Hospital
Assiut, Egypt, Assiut University71515
Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Study Director: Maha El-kholy, Prof

Publications:
Layout table for additonal information
Responsible Party: Samah Mohammad Hussein, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03262064     History of Changes
Other Study ID Numbers: DPOB
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: September 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases