NCT04101448

Brief Summary

The identification of bronchiectasis in COPD has been defined as a different clinical COPD phenotype with greater symptomatic severity, more frequent chronic bronchial infection and exacerbations, and poor prognosis. A causal association has not yet been proven, but it is biologically plausible that COPD, and particularly the infective and exacerbator COPD phenotypes, could be the cause of bronchiectasis without any other known etiology, beyond any mere association or comorbidity.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

September 22, 2019

Last Update Submit

September 22, 2019

Conditions

Keywords

BronchiectasisCOPDPrevalencePrognosis

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Bronchiectasis in COPD

    percentage of bronchiectasis diagnosed by CT chest in COPD patients

    1 year

Secondary Outcomes (3)

  • impact of bronchiectasis on COPD exacerbations

    1 year

  • impact of bronchiectasis on COPD hospitalization

    1 year

  • impact of bronchiectasis on COPD intensive care admission

    1 year

Study Arms (2)

Group A

COPD patients with bronchiectasis

Other: prevalence

Group B

COPD patients without bronchiectasis

Other: prevalence

Interventions

percentage of bronchectasis in COPD and its effect as prognostic measure

Group AGroup B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients diagnosed based on GOLD criteria 2019 with chest CT finding of bronchiectasis

You may qualify if:

  • COPD patients based on GOLD 2019 criteria, stable or in exacerbation

You may not qualify if:

  • acute pneumonia within 2 months
  • malignancy
  • congenital bronchiectasis ( immobile cilia syndrome, Kartagnar syndrome).
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AssiutU

Asyut, 71111, Egypt

RECRUITING

MeSH Terms

Conditions

BronchiectasisPulmonary Disease, Chronic Obstructive

Interventions

Prevalence

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorbidityVital StatisticsData CollectionEpidemiologic MethodsInvestigative TechniquesDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Central Study Contacts

Aliae Mohamed-Hussein

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pulmonology

Study Record Dates

First Submitted

September 22, 2019

First Posted

September 24, 2019

Study Start

September 30, 2019

Primary Completion

September 1, 2020

Study Completion

September 30, 2020

Last Updated

September 24, 2019

Record last verified: 2019-09

Locations