Unraveling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma (TASMA) Extension Study

NCT02975284 | Unknown

• 1 other identifier: NL53703.018.15
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the longterm clinical outcomes, including safety and efficacy parameters after Bronchial Thermoplasty (BT) treatment over a period of 5 years. All patients included in de TASMA trial in the Netherlands will be asked to participate in the TASMA extension study.

Conditions

Severe Asthma

Keywords

bronchial thermoplasty; long term; interventional bronchoscopy

Outcome Measures

Primary Outcomes (3)

• Severe exacerbations rate

  exacerbations / subject / year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.

  measured yearly over 5 years

• Emergency room visit for respiratory symptoms rate

  emergency room visits for respiratory symptoms/subject/year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.

  measured yearly over 5 years

• Hospitalization for respiratory symptoms rate

  hospitalizations for respiratory symptoms/subject/year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.

  measured yearly over 5 years

Secondary Outcomes (13)

• Pre-and post bronchodilator forced expiratory volume at one second (FEV1) and related FEV1 % reversibility

  measured yearly over 5 years

• provocative concentration causing a 20% fall (PC20 ) methacholine test

  measured yearly over 5 years

• Fractional exhaled nitric oxide (FeNO)

  measured yearly over 5 years

• Airway-resistance (sRaw) mechanics

  measured yearly over 5 years

• Airway-conductance(sGaw) mechanics

  measured yearly over 5 years

Eligibility Criteria

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

Study Population

All subjects who underwent BT treatment in the TASMA study (protocol No.NL45394.018.13) and were not lost to follow-up at the end of the 30 week pre-marked visit, and those willing to comply with the study protocol and routine visits for the duration of the study will be included. The expected number of patients included in the TASMA study is n=40. These are patients with severe asthma despite maximal asthma therapy.

You may qualify if:

• Subject participation in the TASMA study
• Ability and willingness to provide informed consent.
• Ability to comply with the study protocol

You may not qualify if:

• Subject participating in another clinical trial involving respiratory intervention which in the opinion of the investigator might interfere with the study.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• University Medical Center Groningen: collaborator

Study Sites (1)

Academisch Medisch Centrum

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Two years after BT blood DNA/RNA will be retained

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Peter Bonta, MD PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. J.T. Annema

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 29, 2016
• Study Start: August 1, 2015
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

NL (1)