NCT03950531

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. Coexistence of bronchiectasis with COPD may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in exacerbations and may negatively affect the exacerbation result parameters.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

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

January 25, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2014

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
Last Updated

May 17, 2019

Status Verified

May 1, 2019

Enrollment Period

4.9 years

First QC Date

May 13, 2019

Last Update Submit

May 15, 2019

Conditions

BronchiectasisChronic Obstructive Pulmonary Disease

Keywords

BronchiectasisChronic Obstructive Pulmonary DiseaseExacerbationComputed Tomography

Outcome Measures

Primary Outcomes (1)

  • Charlson Comorbidity Index

    Comorbidity scores

    1 hour

Secondary Outcomes (1)

  • Spirometry

    1 hour

Study Arms (2)

COPD exacerbation without Bronchiectasis

COPD patients who have been in exacerbation period and have no bronchiectasis

Other: No intervention

COPD exacerbation with Bronchiectasis

COPD patients who have been in exacerbation period and have bronchiectasis

Other: No intervention

Interventions

No interventionOTHER
COPD exacerbation with BronchiectasisCOPD exacerbation without Bronchiectasis

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with COPD exacerbation

You may qualify if:

  • Patients who underwent thoracic tomography in the last year according to index exacerbation date were included in the study

You may not qualify if:

  • Cases that mimic COPD exacerbation (pneumonia, pulmonary thromboembolism, pulmonary congestion, pneumothorax, pleural effusion, lung malignancy, asthma, asthma-COPD overlap syndrome) and patients admitted to the intensive care unit were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BronchiectasisPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nurdan Kokturk, Professor

    Gazi University Faculty of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 15, 2019

Study Start

January 25, 2010

Primary Completion

December 25, 2014

Study Completion

January 25, 2017

Last Updated

May 17, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share