Clinical trial NCT02975284: Unraveling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma (TASMA) Extension Study
Official title: TASMA Extension Study: Long Term Efficacy and Safety of Bronchial Thermoplasty in Severe
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Asthma
Keywords: bronchial thermoplasty
long term
interventional bronchoscopy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
First posted: 2016-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Severe exacerbations rate
timeFrame: measured yearly over 5 years
measure: Emergency room visit for respiratory symptoms rate
timeFrame: measured yearly over 5 years
measure: Hospitalization for respiratory symptoms rate
timeFrame: measured yearly over 5 years
Secondary outcomes:
measure: Pre-and post bronchodilator forced expiratory volume at one second (FEV1) and related FEV1 % reversibility
timeFrame: measured yearly over 5 years
measure: provocative concentration causing a 20% fall (PC20 ) methacholine test
timeFrame: measured yearly over 5 years
measure: Fractional exhaled nitric oxide (FeNO)
timeFrame: measured yearly over 5 years
measure: Airway-resistance (sRaw) mechanics
timeFrame: measured yearly over 5 years
measure: Airway-conductance(sGaw) mechanics
timeFrame: measured yearly over 5 years
measure: forced oscillation technique (FOT)
timeFrame: measured over 5 years
measure: Asthma Control Questionnaire (ACQ) scores
timeFrame: measured yearly over 5 years
measure: Asthma Quality of Life Questionnaire (AQLQ) scores
timeFrame: measured yearly over 5 years
measure: Maintenance dose of oral steroids
timeFrame: measured yearly over 5 years
measure: Maintenance dose of inhaled steroids
timeFrame: measured yearly over 5 years
measure: Rescue medication use
timeFrame: measured yearly over 5 years
measure: Airway smooth muscle (ASM) mass
timeFrame: 2 years after inclusion, 2,5 years after BT
measure: optical coherence tomography (OCT) determined changes
timeFrame: 2 years after inclusion, 2,5 years after BT
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
state: Noord Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Peter Bonta, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: