AsthmaNCT02263794
Hyperpolarized Magnetic Resonance Imaging in Asthma Pre- and Post-Bronchial Thermoplasty
A study testing Conventional Bronchial Thermoplasty and Image Guided Bronchial Thermoplasty in people with Asthma, run by Dr. Grace Parraga at 2 sites in Canada.
Trial summary
Patients in London and Hamilton with severe asthma who are deemed eligible by a respirologist to undergo bronchial thermoplasty treatment will be randomized to image-guided or conventional bronchial thermoplasty using hyperpolarized noble gas imaging. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Conventional Bronchial Thermoplasty and Image Guided Bronchial Thermoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2014to Sep 2020
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
- Male and female aged 18-60 years of age with a clinical diagnosis of asthma, as per:
- Beta-agonist reversibility of FEV1>12%, OR
- Methacholine FEV1 PC20 ≤ 8 mg/ml if not receiving ICS or ≤ 16mg/ml if receiving an ICS.
- Subject has asthma and is taking regular maintenance medication for the past 12 months that includes:
- Inhaled corticosteroid (ICS)
Show all 13Show fewer
- Long-acting beta agonist (LABA)
- Other asthma medication such as leukotriene modifier, or anti-IgE, are acceptable
- FEV1 > 50%pred pre-bronchodilator
- Subject assigned by the clinical team to receive bronchial thermoplasty as part of their asthma treatment plan
- Subject is a non-smoker for 1 year or greater (if former smoker less than 10 pack years total smoking history).
- Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
- Subject is judged to be in otherwise stable health on the basis of medical history
Who cannot join
- Subject is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
- Subject is unable to perform spirometry or plethysmography maneuvers
- Subject is pregnant
- Recent (within 4 weeks of BL Visit 1) or current asthma exacerbation and/or respiratory tract infection
- Subject has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants.) (At the discretion of the MRI Technologist/3T Manager)
- In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster University
Hamilton, Ontario, L8S 4L8
Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
London, Ontario, N6A 5B7
About this study
Patients in London and Hamilton with severe asthma who are deemed eligible by a respirologist to undergo bronchial thermoplasty treatment will be randomized to image-guided or conventional bronchial thermoplasty using hyperpolarized noble gas imaging.
Read the detailed description
This is a one year, single centre randomized controlled trial. Subjects will be identified through the London Asthma Centre located at St. Joseph's Hospital and from Hamilton at St. Joseph's Healthcare, and will be given a letter of information for the study. The study will only recruit subjects with asthma who are undergoing BT as part of their normal clinical care and asthma treatment plan. Those interested will sign the consent form at the clinic.
Bronchial thermoplasty (BT) is a novel FDA approved outpatient asthma treatment procedure which aims to "cure" symptoms by permanently reducing airway smooth muscle mass in the lobar and segmental bronchi. Under local anesthetic, radiofrequency energy is delivered to warm the airway wall to 65 degrees celcius. The effect of this procedure is a reduction in airway smooth muscle mass in the treated airways resulting in a reduced potential for bronchoconstriction.
Fourteen asthma patients will be enrolled in the study and each subject will visit the centre on five occasions (three pre-treatment visits and two post-treatment visits). We will evaluate pre-therapy optimization using inflammometry, pre-therapy ventilation defect reproducibility and BT treatment effects (pre-treatment visit 1= 5±2 days pre-optimization, pre-treatment visit 2 = 15±7 days pre-BT, pre-treatment visit 3 = 5±2 days pre-BT, post-treatment visit 4=6 weeks post-BT, post treatment visit 5 = 6 months post-BT). At pre-treatment visit 1, patients will be randomized to image-guided or conventional therapy. For all subjects, at all visits, spirometry, plethysmography and 3He and/or 129Xe MRI will be performed. Methacholine challenge (MCh) will be performed (for those subjects with FEV1 >60%) at pre-treatment visit 3 and post-treatment visit 4 with spirometry and MRI performed pre- and post-MCh. Pre-treatment visit 3 will include a low-dose thoracic CT that will be used to generate a detailed 3D model of the airway tree. MRI will be co-registered to the CT with 3D airway rendering to enable spatial comparisons between ventilation defects and airways.
All subjects will also complete bi-weekly and weekly quality of life questionnaires. Self-reported data will be uploaded by each subject monthly to our website using a confidential and password protected upload.
MRI of the lungs will be performed using an inhaled contrast agent: either Hyperpolarized Helium-3 or Hyperpolarized Xenon-129. Participants will inhale the hyperpolarized gas and perform a breathhold for up to 16 seconds. Two different types of images will be acquired in the coronal plain during each visit: 1) 1H thoracic cavity, and 2) 3He and/or 129Xe static ventilation. Respiration and oxygen saturation will be monitored throughout the imaging session.
- Conditions
- Asthma
- Being tested
- Conventional Bronchial Thermoplasty, Image Guided Bronchial Thermoplasty
- Keywords
- Bronchial Thermoplasty
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Bronchial ThermoplastyProcedure or surgery
Conventional bronchial thermoplasty is performed during three bronchoscopy sessions each separated by approximately three weeks.
Image Guided Bronchial ThermoplastyProcedure or surgery
Patient-specific bronchial thermoplasty based on imaging data will be performed during one bronchoscopy session.
| Study group | Role | What they receive |
|---|---|---|
| Image guided bronchial thermoplasty | Experimental | At pre-treatment Visit 3, imaging data will be acquired to generate a patient-specific bronchial thermoplasty treatment plan which will include 15-20 target airways, prioritized in order of importance and grouped by lobe, to be targeted during a single session BT treatment procedure. Airways demonstrating dynamic or static bronchoconstriction will be targeted for BT treatment based on their spacial proximity to ventilation defects. Receives: Procedure: Image Guided Bronchial Thermoplasty |
| Conventional bronchial thermoplasty | Active comparator | Patients in this group will undergo conventional 3 stage bronchial thermoplasty (during 3 separate bronchoscopies). Receives: Procedure: Conventional Bronchial Thermoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole lung and lobe specific ventilation defect percent (VDP) as measured by 3He or 129Xe
Change in VDP post BT
Measured: 48 +/- 2 weeks post bronchial thermoplasty treatment
Secondary outcomes (3)
Pulmonary function measurements
Change in pulmonary function post BT
Measured: 48 +/- 2 weeks post bronchial thermoplasty
Quality of Life questionnaires
Change in subject reported QOL post BT
Measured: 48 +/- 2 weeks post bronchial thermoplasty
Dyspnea Scales
Dyspnea scale score post BT
Measured: 48 +/- 2 weeks post bronchial thermoplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Grace Parraga
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor-investigator, Dr. Grace Parraga, University of Western Ontario, Canada
- Investigators
- Grace E Parraga, PhD, Principal investigator, Robarts Research Institute, The University of Western OntarioDavid G McCormack, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263794
- Sponsor's protocol ID
- ROB0039
- Status last verified
- May 2023
- First submitted
- 6 Oct 2014
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Svenningsen S, Kirby M, Starr D, Coxson HO, Paterson NA, McCormack DG, Parraga G. What are ventilation defects in asthma? Thorax. 2014 Jan;69(1):63-71. doi: 10.1136/thoraxjnl-2013-203711. Epub 2013 Aug 16.
PubMed 23956019Janssen LJ. Airway smooth muscle as a target in asthma and the beneficial effects of bronchial thermoplasty. J Allergy (Cairo). 2012;2012:593784. doi: 10.1155/2012/593784. Epub 2012 Sep 16.
PubMed 23024662Pavord ID, Cox G, Thomson NC, Rubin AS, Corris PA, Niven RM, Chung KF, Laviolette M; RISA Trial Study Group. Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. Am J Respir Crit Care Med. 2007 Dec 15;176(12):1185-91. doi: 10.1164/rccm.200704-571OC. Epub 2007 Sep 27.
PubMed 17901415Capaldi DPI, Guo F, Xing L, Parraga G. Pulmonary Ventilation Maps Generated with Free-breathing Proton MRI and a Deep Convolutional Neural Network. Radiology. 2021 Feb;298(2):427-438. doi: 10.1148/radiol.2020202861. Epub 2020 Dec 8.
PubMed 33289613Svenningsen S, Nair P, Guo F, McCormack DG, Parraga G. Is ventilation heterogeneity related to asthma control? Eur Respir J. 2016 Aug;48(2):370-9. doi: 10.1183/13993003.00393-2016. Epub 2016 May 12.
PubMed 27174885
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarized Magnetic Resonance Imaging in Asthma Pre- and Post-Bronchial Thermoplasty
- ClinicalTrials.gov ID
- NCT02263794
- Acronym / sponsor ID
- ROB0039
- Conditions
- Asthma
- Keywords
- Bronchial Thermoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Dr. Grace ParragaUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Oct 2014 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 13 Oct 2014 (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.
Patients in London and Hamilton with severe asthma who are deemed eligible by a respirologist to undergo bronchial thermoplasty treatment will be randomized to image-guided or conventional bronchial thermoplasty using hyperpolarized noble gas imaging.
Detailed description
This is a one year, single centre randomized controlled trial. Subjects will be identified through the London Asthma Centre located at St. Joseph's Hospital and from Hamilton at St. Joseph's Healthcare, and will be given a letter of information for the study. The study will only recruit subjects with asthma who are undergoing BT as part of their normal clinical care and asthma treatment plan. Those interested will sign the consent form at the clinic.
Bronchial thermoplasty (BT) is a novel FDA approved outpatient asthma treatment procedure which aims to "cure" symptoms by permanently reducing airway smooth muscle mass in the lobar and segmental bronchi. Under local anesthetic, radiofrequency energy is delivered to warm the airway wall to 65 degrees celcius. The effect of this procedure is a reduction in airway smooth muscle mass in the treated airways resulting in a reduced potential for bronchoconstriction.
Fourteen asthma patients will be enrolled in the study and each subject will visit the centre on five occasions (three pre-treatment visits and two post-treatment visits). We will evaluate pre-therapy optimization using inflammometry, pre-therapy ventilation defect reproducibility and BT treatment effects (pre-treatment visit 1= 5±2 days pre-optimization, pre-treatment visit 2 = 15±7 days pre-BT, pre-treatment visit 3 = 5±2 days pre-BT, post-treatment visit 4=6 weeks post-BT, post treatment visit 5 = 6 months post-BT). At pre-treatment visit 1, patients will be randomized to image-guided or conventional therapy. For all subjects, at all visits, spirometry, plethysmography and 3He and/or 129Xe MRI will be performed. Methacholine challenge (MCh) will be performed (for those subjects with FEV1 >60%) at pre-treatment visit 3 and post-treatment visit 4 with spirometry and MRI performed pre- and post-MCh. Pre-treatment visit 3 will include a low-dose thoracic CT that will be used to generate a detailed 3D model of the airway tree. MRI will be co-registered to the CT with 3D airway rendering to enable spatial comparisons between ventilation defects and airways.
All subjects will also complete bi-weekly and weekly quality of life questionnaires. Self-reported data will be uploaded by each subject monthly to our website using a confidential and password protected upload.
MRI of the lungs will be performed using an inhaled contrast agent: either Hyperpolarized Helium-3 or Hyperpolarized Xenon-129. Participants will inhale the hyperpolarized gas and perform a breathhold for up to 16 seconds. Two different types of images will be acquired in the coronal plain during each visit: 1) 1H thoracic cavity, and 2) 3He and/or 129Xe static ventilation. Respiration and oxygen saturation will be monitored throughout the imaging session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Image guided bronchial thermoplasty | Experimental | Procedure: Image Guided Bronchial ThermoplastyAt pre-treatment Visit 3, imaging data will be acquired to generate a patient-specific bronchial thermoplasty treatment plan which will include 15-20 target airways, prioritized in order of importance and grouped by lobe, to be targeted during a single session BT treatment procedure. Airways demonstrating dynamic or static bronchoconstriction will be targeted for BT treatment based on their spacial proximity to ventilation defects. |
| Conventional bronchial thermoplasty | Active comparator | Procedure: Conventional Bronchial ThermoplastyPatients in this group will undergo conventional 3 stage bronchial thermoplasty (during 3 separate bronchoscopies). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
- Male and female aged 18-60 years of age with a clinical diagnosis of asthma, as per:
- Subject has asthma and is taking regular maintenance medication for the past 12 months that includes:
- FEV1 > 50%pred pre-bronchodilator
- Subject assigned by the clinical team to receive bronchial thermoplasty as part of their asthma treatment plan
Key exclusion criteria (6 listed)
- Subject is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
- Subject is unable to perform spirometry or plethysmography maneuvers
- Subject is pregnant
- Recent (within 4 weeks of BL Visit 1) or current asthma exacerbation and/or respiratory tract infection
- Subject has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants.) (At the discretion of the MRI Technologist/3T Manager)
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 |
|---|---|---|
| Conventional Bronchial ThermoplastyConventional bronchial thermoplasty is performed during three bronchoscopy sessions each separated by approximately three weeks. | Procedure or surgery | Conventional bronchial thermoplasty |
| Image Guided Bronchial ThermoplastyPatient-specific bronchial thermoplasty based on imaging data will be performed during one bronchoscopy session. | Procedure or surgery | Image guided bronchial thermoplasty |
Primary outcome
Whole lung and lobe specific ventilation defect percent (VDP) as measured by 3He or 129Xe
Time frame: 48 +/- 2 weeks post bronchial thermoplasty treatment
Change in VDP post BT
3 secondary outcomes
Pulmonary function measurements
Time frame: 48 +/- 2 weeks post bronchial thermoplasty
Quality of Life questionnaires
Time frame: 48 +/- 2 weeks post bronchial thermoplasty
Dyspnea Scales
Time frame: 48 +/- 2 weeks post bronchial thermoplasty
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Background: PubMed 23956019Svenningsen S, Kirby M, Starr D, Coxson HO, Paterson NA, McCormack DG, Parraga G. What are ventilation defects in asthma? Thorax. 2014 Jan;69(1):63-71. doi: 10.1136/thoraxjnl-2013-203711. Epub 2013 Aug 16.
- Background: PubMed 23024662Janssen LJ. Airway smooth muscle as a target in asthma and the beneficial effects of bronchial thermoplasty. J Allergy (Cairo). 2012;2012:593784. doi: 10.1155/2012/593784. Epub 2012 Sep 16.
- Background: PubMed 17901415Pavord ID, Cox G, Thomson NC, Rubin AS, Corris PA, Niven RM, Chung KF, Laviolette M; RISA Trial Study Group. Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. Am J Respir Crit Care Med. 2007 Dec 15;176(12):1185-91. doi: 10.1164/rccm.200704-571OC. Epub 2007 Sep 27.
- Derived from this study: PubMed 33289613Capaldi DPI, Guo F, Xing L, Parraga G. Pulmonary Ventilation Maps Generated with Free-breathing Proton MRI and a Deep Convolutional Neural Network. Radiology. 2021 Feb;298(2):427-438. doi: 10.1148/radiol.2020202861. Epub 2020 Dec 8.
- Derived from this study: PubMed 27174885Svenningsen S, Nair P, Guo F, McCormack DG, Parraga G. Is ventilation heterogeneity related to asthma control? Eur Respir J. 2016 Aug;48(2):370-9. doi: 10.1183/13993003.00393-2016. Epub 2016 May 12.
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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.
Grace E Parraga, PhD principal investigator
Robarts Research Institute, The University of Western Ontario
David G McCormack, MD principal investigator
London Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Bronchial Thermoplasty and Image Guided Bronchial Thermoplasty in people with Asthma, run by Dr. Grace Parraga at 2 sites in Canada.
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 13 inclusion and 6 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: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole lung and lobe specific ventilation defect percent (VDP) as measured by 3He or 129Xe (time frame: 48 +/- 2 weeks post bronchial thermoplasty treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02263794, which also lists 5 linked publications.
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 12 May 2023.