Bronchiectasis and NTM Research Registry | NCT01822834

Studies
Bronchiectasis and NTM Research Registry

NCT01822834

Sponsor

COPD Foundation

Status

Recruiting

Last Update Posted

Mar 22, 2022Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Non-CF Bronchiectasis
Nontuberculosis Mycobacteria (NTM)

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2050Estimated

Completion Date

Dec 2050Estimated

First Submitted Date

Mar 28, 2013

First Submission Date that Met QC Criteria

Mar 28, 2013

First Posted Date

Apr 2, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2022

Last Update Posted Date

Mar 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Bronchiectasis Research Registry is a consolidated database of non-cystic fibrosis (non-CF) Bronchiectasis and Nontuberculosis Mycobacteria (NTM) patients from multiple clinical institutions.

Detailed Description

The Bronchiectasis Research Registry is a consolidated database of non-cystic fibrosis (non-CF) Bronchiectasis and Nontuberculosis Mycobacteria (NTM) patients from multiple clinical institutions. The goal of the Bronchiectasis Research Registry is to support collaborative research and assist in the planning of multi-center clinical trials for the treatment of NTM and non-CF Bronchiectasis, a progressive, non-curable disease of the lungs, which afflicts thousands of patients. The Registry will also be used to provide better insight into the study of the different types of Bronchiectasis, as well as the pathophysiology of the disorder. In 2012, in collaboration with NTM Info and Research, Inc (NTMir) and the consortium members, the COPD Foundation expanded the Bronchiectasis Research Registry to enroll patients with "non tuberculous mycobacteria (NTM) only". Prior to this time, the registry included individuals with Bronchiectasis, with or without NTM.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

20 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-CF Bronchiectasis Patients with or without NTM		Patients over the age of 18 with non-CF Bronchiectasis with or without Nontuberculosis Mycobacteria (NTM).
Nontuberculosis Mycobacteria (NTM)		Patients over the age of 18 with Nontuberculosis Mycobacteria (NTM)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Recruitment and Data analysis	The COPD Foundation expects to assist at least 4 researchers (with patient recruitment and/or data analysis) annually.	December 2050

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over the age of 18
non-CF Bronchiectasis
Nontuberculosis Mycobacteria (NTM)

Exclusion Criteria:

Under the age of 18
CF Bronchiectasis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Patients over the age of 18 with non-CF Bronchiectasis and/or Nontuberculosis Mycobacteria (NTM).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Delia Prieto	Contact	1-866-731-2673	272

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
COPD Foundation	Recruiting	Washington D.C.	District of Columbia		United States