NCT01976130

Brief Summary

Study hypothesis: Chronic Obstructive Pulmonary Disease (COPD) patients with chronic bacterial colonization have lower levels of mucins and antimicrobial peptides in their airways

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
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

June 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

5.8 years

First QC Date

October 22, 2013

Last Update Submit

September 7, 2016

Conditions

Bacterial Infection in COPD

Outcome Measures

Primary Outcomes (1)

  • Mucins in sputum

    Day 1

Secondary Outcomes (1)

  • Antimicrobial peptides in sputum

    Day 1

Study Arms (1)

bronchoscopy

EXPERIMENTAL

Procedure

Procedure: Bronchoscopy

Interventions

BronchoscopyPROCEDURE
bronchoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD

You may not qualify if:

  • Acute exacerbation in the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

November 5, 2013

Study Start

June 1, 2012

Primary Completion

March 1, 2018

Study Completion

June 1, 2018

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations

ES(1)