Unravelling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma: The TASMA study

Unravelling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma: The TASMA study - Targets of ThermoplAsty in Severe asthMA: TASMA-study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47504

Enrollment

Registered

2014-03-17

Start date

2014-04-09

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma asthmatic bronchitis reversible airway obstruction

Interventions

Bronchial Thermoplasty by the Alair system (Boston Scientific, USA). 1 (immediate BT group n=20) of 2 (delayed BT group n=20) additional bronchoscopies for airway-sampling and -imaging.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: symptomatic severe asthma despite optimal inhalation therapy FEV150% (stabilized on ICS/ABA) or post-bronchodilator FEV1 60% non-smokers

Exclusion criteria

Exclusion criteria: age 65 years other respiratory tract disease than asthma including bronchiectasis, infection use of immunosuppressive therapy other than prednisolone

Design outcomes

Primary

Measure	Time frame
Primary endpoint is the difference in change in ASM mass as determined by the percentage of ASM surface area in airway biopsies between the immediate BT group and the delayed BT group = control group (n=20/group)	—

Secondary

Measure	Time frame
Secondary endpoints are BT-induced changes in: 1. ASM mass as determined by percentage/absolute ASM surface area or distance of reticular basement membrane (RBM) to ASM layer in endobronchial biopsies. 2. mucosal endobronchial biopsy and induced sputum inflammatory cell density/counts (eosinophils and neutrophils); 3. OCT- and rEBUS-determined changes in structural airway remodelling as measured by changes in lumen area (Ai) and airway wall thickness (Aaw) and composition (Figure 4); 4. Clinical outcome parameters including pulmonary function tests (pre-and post bronchodilator FEV1, PC20 methacholine (PC20 Meth), FeNO and airway-resistance (sRaw)/-compliance(sGaw)/-mechanics (FOT) parameters, asthma control questionnaire (ACQ), asthma related quality of life questionnaire (AQLQ), health care utilization (number of severe asthma exacerbations, emergency room visits, hospital and intensive care unit (ICU) admissions). Statistical analyses performed on these secondary endpoints are: A. comparative between BT treatment and control groups (n=20/group) if not a primary endpoint; B. paired before and after BT analyses in all BT treated subjects (n=40) and; C. comparative between BT-treated and untreated (right middle lobe RML) areas of the lung in all BT-treated subjects (n=40) if applicable for that endpoint: Correlation/responder analyses between baseline factors and endpoints and predefined subgroup analyses.	—

Measure

Time frame

Secondary endpoints are BT-induced changes in: 1. ASM mass as determined by percentage/absolute ASM surface area or distance of reticular basement membrane (RBM) to ASM layer in endobronchial biopsies. 2. mucosal endobronchial biopsy and induced sputum inflammatory cell density/counts (eosinophils and neutrophils); 3. OCT- and rEBUS-determined changes in structural airway remodelling as measured by changes in lumen area (Ai) and airway wall thickness (Aaw) and composition (Figure 4); 4. Clinical outcome parameters including pulmonary function tests (pre-and post bronchodilator FEV1, PC20 methacholine (PC20 Meth), FeNO and airway-resistance (sRaw)/-compliance(sGaw)/-mechanics (FOT) parameters, asthma control questionnaire (ACQ), asthma related quality of life questionnaire (AQLQ), health care utilization (number of severe asthma exacerbations, emergency room visits, hospital and intensive care unit (ICU) admissions). Statistical analyses performed on these secondary endpoints are: A. comparative between BT treatment and control groups (n=20/group) if not a primary endpoint; B. paired before and after BT analyses in all BT treated subjects (n=40) and; C. comparative between BT-treated and untreated (right middle lobe RML) areas of the lung in all BT-treated subjects (n=40) if applicable for that endpoint: Correlation/responder analyses between baseline factors and endpoints and predefined subgroup analyses.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)