Bronchoscopic EmphysemA Treatment in THE NetherLands

NCT02815683 | Recruiting

• 1 other identifier: BREATHE-NL
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the Netherlands. It is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies. Overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. This is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations.

Conditions

COPD

Keywords

Bronchoscopy; Emphysema

Outcome Measures

Primary Outcomes (1)

• Quality of treatment

  Quality will be assessed by a High resolution CT check at 30 day post-treatment of the placement of the valves.

  Baseline-30 days

Secondary Outcomes (5)

• Change from baseline in lungfunction at 5 years follow up after treatment.

  Baseline- 5 years

• Change from baseline in exercise capacity at 5 years follow up after treatment.

  Baseline- 5 years

• Change from baseline in breathlessness at 5 years follow up after treatment.

  Baseline- 5 years

• Change from baseline in health status at 5 years follow up after treatment.

  Baseline- 5 years

• The incidence of a pneumothorax after the treatment until 5 years follow up.

  Baseline- 5 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.

You may qualify if:

• Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (2)

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

Maastricht University Medical Center

Maastricht, Netherlands

RECRUITING

Related Publications (2)

• Bakker JT, Hartman JE, Klooster K, Charbonnier JP, Tsiaousis M, Vliegenthart R, Slebos DJ. Endobronchial valve treatment improves chest-CT diaphragm configuration in COPD. Respir Med. 2024 Nov-Dec;234:107856. doi: 10.1016/j.rmed.2024.107856. Epub 2024 Nov 6.

  PMID: 39515624 DERIVED

• Hartman JE, Klooster K, Ten Hacken NHT, van Dijk M, Slebos DJ. Patient Satisfaction and Attainment of Patient-Specific Goals after Endobronchial Valve Treatment. Ann Am Thorac Soc. 2021 Jan;18(1):68-74. doi: 10.1513/AnnalsATS.202004-342OC.

  PMID: 32881586 DERIVED

Related Links

• Website of the bronchoscopic intervention center of the UMCG

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dirk-Jan Slebos, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Klooster, PhD

CONTACT

+31503616161; k.klooster@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 28, 2016
• Study Start: September 1, 2016
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)