AsthmaNCT01974921
Study of Physiopathological Mechanisms and Results of Treatment With Bronchial Thermoplasty in Severe Asthma
A study testing ALAIR Catheter. Radiofrequency system. in people with Asthma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate clinical and histological response to bronchial thermoplasty in severe asthma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- ALAIR Catheter. Radiofrequency system.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients under 18 years old.
- Severe persistent asthma according to GINA.
- Inhaled corticosteroids and long-acting ß2 agonist (LABA).
- Other medications for asthma, as oral corticosteroids, anti-IgE, theofiline, etc. are also acceptable.
- Asthma Quality of Life Questionnaire (AQLQ) < 7
- Asthma Control Test (ACT) < 19
- ≥ 2 exacerbations in last year
Who cannot join
- History of cigarette smoking with > 15 pack/years.
- Other respiratory diseases.
- Comorbidity that can justify the symptoms of the patients.
- Life-threating unstable asthma.
- Any contraindication to perform a bronchoscopy (respiratory insufficiency, coagulation abnormalities, allergy to sedative drugs, etc.)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Alfons Torrego, M.D.
Ana Muñoz, M.D.
About this study
The purpose of this study is to evaluate clinical and histological response to bronchial thermoplasty in severe asthma patients.
Read the detailed description
Bronchial thermoplasty is a new therapeutic tool for severe and uncontrolled asthma patients. Clinical trials have demonstrated clinical benefits regarding quality of life and exacerbations. Animal models suggested the reduction of bronchial smooth muscle as the principal responsible for the clinical benefits observed in asthma patients treated in the clinical trials, although there is little information about its mechanism of action, and limited to a very small number of case reports. Given that the mechanism of action of bronchial thermoplasty is still not well understood, we proposed a biological study in asthma patients treated with bronchial thermoplasty with the purpose to analyze changes in inflammatory markers and histological samples, as well as its correlation with clinical outcomes in real practice.
- Conditions
- Asthma
- Being tested
- ALAIR Catheter. Radiofrequency system.
- Keywords
- Asthma, Bronchial Thermoplasty, Bronchial smooth muscle
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALAIR Catheter. Radiofrequency system.Device
Radiofrequency with Alair Catheter trhough flexible bronchoscopy in three different sessions (right lower lobe, left lower lobe, both upper lobes).
| Study group | Role | What they receive |
|---|---|---|
| Bronchial thermoplasty | Experimental | ALAIR Catheter. Radiofrequency system. Receives: Device: ALAIR Catheter. Radiofrequency system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchial smooth muscle.
Measured: Change from baseline in bronchial smooth muscle at 6 months post-treatment..
Secondary outcomes (7)
Questionnaire of Quality of life (AQLQ)
Measured: Change from baseline in AQLQ at 6 months post-treatment.
Questionnaire of asthma control (ACT)
Measured: Change from baseline in ACT at 6 months post-treatment.
Number of exacerbations
Measured: Change from baseline in number of exacerbations at 6 months post-treatment.
Number of hospitalizations
Measured: Change from baseline in number of hospitalizations at 6 months post-treatment.
Respiratory function
Measured: Change from baseline in respiratory function at 6 months post-treatment.
Radiological findings (thorax HRCT scan)
Measured: Change from baseline in radiological findings at 6 months post-treatment.
Inflammatory markers
FeNO eNOSE Bronchial biopsies Sputum Serum
Measured: Change from baseline in biological inflammatory markers at 6 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfons Torrego, M.D., Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974921
- Sponsor's protocol ID
- IIBSP-TER-2013-70
- Status last verified
- Oct 2015
- First submitted
- 22 Oct 2013
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Physiopathological Mechanisms and Results of Treatment With Bronchial Thermoplasty in Severe Asthma
- ClinicalTrials.gov ID
- NCT01974921
- Acronym / sponsor ID
- IIBSP-TER-2013-70
- Conditions
- Asthma
- Keywords
- Asthma, Bronchial Thermoplasty, Bronchial smooth muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate clinical and histological response to bronchial thermoplasty in severe asthma patients.
Detailed description
Bronchial thermoplasty is a new therapeutic tool for severe and uncontrolled asthma patients. Clinical trials have demonstrated clinical benefits regarding quality of life and exacerbations. Animal models suggested the reduction of bronchial smooth muscle as the principal responsible for the clinical benefits observed in asthma patients treated in the clinical trials, although there is little information about its mechanism of action, and limited to a very small number of case reports. Given that the mechanism of action of bronchial thermoplasty is still not well understood, we proposed a biological study in asthma patients treated with bronchial thermoplasty with the purpose to analyze changes in inflammatory markers and histological samples, as well as its correlation with clinical outcomes in real practice.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchial thermoplasty | Experimental | Device: ALAIR Catheter. Radiofrequency system.ALAIR Catheter. Radiofrequency system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients under 18 years old.
- Severe persistent asthma according to GINA.
- Inhaled corticosteroids and long-acting ß2 agonist (LABA).
- Other medications for asthma, as oral corticosteroids, anti-IgE, theofiline, etc. are also acceptable.
- Asthma Quality of Life Questionnaire (AQLQ) < 7
Key exclusion criteria (5 listed)
- History of cigarette smoking with > 15 pack/years.
- Other respiratory diseases.
- Comorbidity that can justify the symptoms of the patients.
- Life-threating unstable asthma.
- Any contraindication to perform a bronchoscopy (respiratory insufficiency, coagulation abnormalities, allergy to sedative drugs, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALAIR Catheter. Radiofrequency system.Radiofrequency with Alair Catheter trhough flexible bronchoscopy in three different sessions (right lower lobe, left lower lobe, both upper lobes). | Device | Bronchial thermoplasty |
Primary outcome
Bronchial smooth muscle.
Time frame: Change from baseline in bronchial smooth muscle at 6 months post-treatment..
7 secondary outcomes
Questionnaire of Quality of life (AQLQ)
Time frame: Change from baseline in AQLQ at 6 months post-treatment.
Questionnaire of asthma control (ACT)
Time frame: Change from baseline in ACT at 6 months post-treatment.
Number of exacerbations
Time frame: Change from baseline in number of exacerbations at 6 months post-treatment.
Number of hospitalizations
Time frame: Change from baseline in number of hospitalizations at 6 months post-treatment.
Respiratory function
Time frame: Change from baseline in respiratory function at 6 months post-treatment.
Radiological findings (thorax HRCT scan)
Time frame: Change from baseline in radiological findings at 6 months post-treatment.
Inflammatory markers
Time frame: Change from baseline in biological inflammatory markers at 6 months post-treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfons Torrego, M.D. principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALAIR Catheter. Radiofrequency system. in people with Asthma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alfons Torrego, M.D. (0034 936655972 ext. 5967, atorrego@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchial smooth muscle. (time frame: Change from baseline in bronchial smooth muscle at 6 months post-treatment..). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015; AzTrials last refreshed its copy on 8 Nov 2026.