NCT03262064

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

July 5, 2019

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

August 22, 2017

Last Update Submit

July 1, 2019

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (1)

  • ( Severity of Bronchiectasis will be measured according to BSI scoring system and FACED scoring system

    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

    Baseline

Secondary Outcomes (1)

  • management of bronchectasis according to severity index

    Baseline

Interventions

Pulmonary function tests,Bronchiectasis severity index scoreCOMBINATION_PRODUCT

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • patient diagnosed as bronchiectasis according to clinical picture and high- resolution computed tomography scan of the chest.
  • can perform pulmonary function test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Assiut University71515, Egypt

Location

Related Publications (4)

  • Wilson CB, Jones PW, O'Leary CJ, Hansell DM, Cole PJ, Wilson R. Effect of sputum bacteriology on the quality of life of patients with bronchiectasis. Eur Respir J. 1997 Aug;10(8):1754-60. doi: 10.1183/09031936.97.10081754.

    PMID: 9272915BACKGROUND

  • Eshed I, Minski I, Katz R, Jones PW, Priel IE. Bronchiectasis: correlation of high-resolution CT findings with health-related quality of life. Clin Radiol. 2007 Feb;62(2):152-9. doi: 10.1016/j.crad.2006.08.015.

    PMID: 17207698BACKGROUND

  • Chalmers JD, Goeminne P, Aliberti S, McDonnell MJ, Lonni S, Davidson J, Poppelwell L, Salih W, Pesci A, Dupont LJ, Fardon TC, De Soyza A, Hill AT. The bronchiectasis severity index. An international derivation and validation study. Am J Respir Crit Care Med. 2014 Mar 1;189(5):576-85. doi: 10.1164/rccm.201309-1575OC.

    PMID: 24328736BACKGROUND

  • Martinez-Garcia MA, de Gracia J, Vendrell Relat M, Giron RM, Maiz Carro L, de la Rosa Carrillo D, Olveira C. Multidimensional approach to non-cystic fibrosis bronchiectasis: the FACED score. Eur Respir J. 2014 May;43(5):1357-67. doi: 10.1183/09031936.00026313. Epub 2013 Nov 14.

    PMID: 24232697BACKGROUND

MeSH Terms

Conditions

Bronchiectasis

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

  • Maha El-kholy, Prof

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 22, 2017

First Posted

August 25, 2017

Study Start

July 1, 2017

Primary Completion

September 1, 2018

Study Completion

January 1, 2019

Last Updated

July 5, 2019

Record last verified: 2017-09

Locations

EG(1)