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

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ClinicalTrials.gov Identifier: NCT02975284
Recruitment Status : Active, not recruiting
First Posted : November 29, 2016
Last Update Posted : July 3, 2019
Sponsor:
Collaborator:
University Medical Center Groningen
Information provided by (Responsible Party):
Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Condition or disease
Severe Asthma

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TASMA Extension Study: Long Term Efficacy and Safety of Bronchial Thermoplasty in Severe
Study Start Date : August 2015
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma




Primary Outcome Measures :
  1. Severe exacerbations rate [ Time Frame: measured yearly over 5 years ]
    exacerbations / subject / year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.

  2. Emergency room visit for respiratory symptoms rate [ Time Frame: measured yearly over 5 years ]
    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.

  3. Hospitalization for respiratory symptoms rate [ Time Frame: measured yearly over 5 years ]
    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.


Secondary Outcome Measures :
  1. Pre-and post bronchodilator forced expiratory volume at one second (FEV1) and related FEV1 % reversibility [ Time Frame: measured yearly over 5 years ]
    measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment

  2. provocative concentration causing a 20% fall (PC20 ) methacholine test [ Time Frame: measured yearly over 5 years ]
    measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment

  3. Fractional exhaled nitric oxide (FeNO) [ Time Frame: measured yearly over 5 years ]
    measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment

  4. Airway-resistance (sRaw) mechanics [ Time Frame: measured yearly over 5 years ]
    measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment

  5. Airway-conductance(sGaw) mechanics [ Time Frame: measured yearly over 5 years ]
    measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment

  6. forced oscillation technique (FOT) [ Time Frame: measured over 5 years ]
    measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment

  7. Asthma Control Questionnaire (ACQ) scores [ Time Frame: measured yearly over 5 years ]
    measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment

  8. Asthma Quality of Life Questionnaire (AQLQ) scores [ Time Frame: measured yearly over 5 years ]
    measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment

  9. Maintenance dose of oral steroids [ Time Frame: measured yearly over 5 years ]
    measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment

  10. Maintenance dose of inhaled steroids [ Time Frame: measured yearly over 5 years ]
    measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment

  11. Rescue medication use [ Time Frame: measured yearly over 5 years ]
    measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment

  12. Airway smooth muscle (ASM) mass [ Time Frame: 2 years after inclusion, 2,5 years after BT ]
    ASM mass as determined by percentage/absolute ASM surface area and distance of reticular basement membrane (RBM) to ASM layer in endobronchial biopsies

  13. optical coherence tomography (OCT) determined changes [ Time Frame: 2 years after inclusion, 2,5 years after BT ]
    OCT determined changes in structural airway remodelling as measured by changes in lumen area (Ai) and airway wall thickness (Aaw).


Biospecimen Retention:   Samples With DNA
Two years after BT blood DNA/RNA will be retained


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975284


Locations
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Netherlands
Academisch Medisch Centrum
Amsterdam, Noord Holland, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Medical Center Groningen
Investigators
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Principal Investigator: Peter Bonta, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Responsible Party: Prof J.T. Annema, Prof. Dr. J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02975284     History of Changes
Other Study ID Numbers: NL53703.018.15
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
bronchial thermoplasty
long term
interventional bronchoscopy

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases