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

Severe Asthma Clinical Trial

Official title:

TASMA Extension Study: Long Term Efficacy and Safety of Bronchial Thermoplasty in Severe

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02975284
• Other study ID #: NL53703.018.15
• Status: Active, not recruiting
• Start date: August 2015
• Est. completion date: September 2024

Study information

• Verified date: July 2019
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subject participation in the TASMA study

• Ability and willingness to provide informed consent.

• Ability to comply with the study protocol

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum	Amsterdam	Noord Holland

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Pre-and post bronchodilator forced expiratory volume at one second (FEV1) and related FEV1 % reversibility	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment	measured yearly over 5 years
Secondary	provocative concentration causing a 20% fall (PC20 ) methacholine test	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment	measured yearly over 5 years
Secondary	Fractional exhaled nitric oxide (FeNO)	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment	measured yearly over 5 years
Secondary	Airway-resistance (sRaw) mechanics	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment	measured yearly over 5 years
Secondary	Airway-conductance(sGaw) mechanics	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment	measured yearly over 5 years
Secondary	forced oscillation technique (FOT)	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment	measured over 5 years
Secondary	Asthma Control Questionnaire (ACQ) scores	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment	measured yearly over 5 years
Secondary	Asthma Quality of Life Questionnaire (AQLQ) scores	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment	measured yearly over 5 years
Secondary	Maintenance dose of oral steroids	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment	measured yearly over 5 years
Secondary	Maintenance dose of inhaled steroids	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment	measured yearly over 5 years
Secondary	Rescue medication use	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment	measured yearly over 5 years
Secondary	Airway smooth muscle (ASM) mass	ASM mass as determined by percentage/absolute ASM surface area and distance of reticular basement membrane (RBM) to ASM layer in endobronchial biopsies	2 years after inclusion, 2,5 years after BT
Secondary	optical coherence tomography (OCT) determined changes	OCT determined changes in structural airway remodelling as measured by changes in lumen area (Ai) and airway wall thickness (Aaw).	2 years after inclusion, 2,5 years after BT