AsthmaNCT00214539
Research in Severe Asthma (RISA) Trial
A study testing Bronchial Thermoplasty with the Alair System in people with Asthma, run by Boston Scientific Corporation.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the Alair System for the treatment of severe refractory asthma. This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy in patients with severe asthma refractory to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Bronchial Thermoplasty with the Alair System
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Aug 2006
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory adult; age 18-65 years
- Asthma requiring regular maintenance medication that includes high dose inhaled corticosteroid AND long acting β2 agonist (LABA) with or without other asthma maintenance medications. Oral prednisone ≤30 mg/day, leukotriene modifiers, theophylline or other asthma control drugs may be prescribed at the physician's discretion.
- Pre-bronchodilator forced expiratory volume in one second (FEV1) ≥50% predicted (patients stabilized on inhaled corticosteroids (ICS) and long acting β2 agonists)
- PC20 < 4 mg/ml per methacholine inhalation test using standardized methods, for patients with pre-bronchodilator FEV1 ≥60% predicted (or FEV1 > lower limit defined by individual hospital protocol). PC20 is the provocative concentration of Provocholine® (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from Baseline
- Reversible bronchoconstriction during the 12 months prior to enrollment, as demonstrated by an increase in FEV1 of at least 12% 30 minutes after 4 puffs of short-acting β2 agonist, for patients with pre-bronchodilator FEV1 < 60% predicted (or FEV1 < lower limit defined by individual hospital protocol)
- Patient must be symptomatic, despite medication with high dose inhaled corticosteroids and LABA, by at least one of the following:
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- Use of rescue medication (short-acting β2 agonist) at least 8 of the 14 days prior to enrollment OR
- Daytime symptoms at least 10 of the 14 days prior to enrollment
- Non-smoker x 1 year or greater (if former smoker, less than 10 pack years total smoking history)
- Patient must be suitable for bronchoscopy in the opinion of the investigator or per hospital guidelines
- Willingness and ability to give written Informed Consent
- Willingness and ability to comply with the study protocol, including requirements for taking and abstaining from medications
Who cannot join
- Participation in another clinical trial involving respiratory intervention that could affect the outcome measures of this study, within 6 weeks prior to randomization. Patients will be disqualified from the study if they enter another study or fail to comply with prescribed asthma medications.
- Use of immunosuppressant therapy (e.g., methotrexate).
- Current or recent lower respiratory tract infection (resolved less than 6 weeks from enrollment testing)
- History of recurrent (no more than three in the last three months) lower respiratory tract infection requiring antibiotics
- Presence of other respiratory diseases including emphysema, cystic fibrosis, vocal cord dysfunction, mechanical upper airway obstruction, obstructive sleep apnea, Churg-Strauss syndrome, cardiac dysfunction, allergic bronchopulmonary aspergillosis
- DLCO (diffusion capacity) < 70% predicted
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- Uncontrolled sinus disease
- Uncontrolled gastro-esophageal reflux disease
- Use of implanted electronic device such as a pacemaker or internal cardiac defibrillator
- Use of external pacemaker
- Significant co-morbid illness such as cancer, renal failure, liver disease or cerebral vascular disease
- Post-bronchodilator FEV1 of less than 55% predicted
- Known systemic hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents
- Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine, benzodiazepines and opioids
- Use of a systemic b-adrenergic blocking agent
- Other medical criteria.
About this study
Official title: Multicenter Randomized Clinical Trial of Bronchial Thermoplasty With the Alair System for the Treatment of Severe Asthma
The purpose of this study is to evaluate the safety and efficacy of the Alair System for the treatment of severe refractory asthma.
This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy in patients with severe asthma refractory to standard medication therapy. A total of 30 subjects will be randomized 1:1 to the Alair Group (Medical management + Alair Treatment) OR the Control Group (Medical management only).
Read the detailed description
Multicenter, randomized, clinical trial conducted at 8 Investigational Sites in 3 countries.
Subjects in the Alair group to be administered the Alair treatment in 3 separate bronchoscopy sessions, while subjects in the Control group will complete 3 "Control Visits" to the Physicians office, timed to coincide with the 3 treatment bronchoscopy sessions. Following completion of all three procedures or Control Visits subjects will be evaluated at 6 weeks and 12 weeks. All subjects to remain on their maintenance asthma medications until they are evaluated again at 22 weeks after the last procedure or Control Visit. This phase from the last procedure or Control Visit out to 22 Weeks after the last procedure or Control Visit is termed the Steroid Stable Phase.
Subjects will undergo a 14 week period from 22 Weeks to 36 Weeks (termed the Steroid Wean Phase) during which an attempt will be made to wean them off either their maintenance inhaled corticosteroids (ICS) or, if taking maintenance oral corticosteroids (OCS), their oral steroids. If a subject cannot tolerate the steroid reduction at a particular level (as evidenced by loss of asthma control), they will be stabilized on their last tolerable dose of steroid.
All subjects will maintain their reduced steroid dosage from the end of the Steroid Wean Phase at 36 weeks to their final evaluations at the end of the Study at 52 weeks (termed the Reduced Steroid Phase). All subjects will be exited from the study following completion of the 52 week evaluations.
- Conditions
- Asthma
- Being tested
- Bronchial Thermoplasty with the Alair System, Control
- Keywords
- Asthma, 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.
Bronchial Thermoplasty with the Alair SystemProcedure or surgery
Also called Alair System
Alair treatment plus standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤ 30 mg/day.
ControlDrug
Standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤30 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Alair treatment plus standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤ 30 mg/day. Receives: Procedure: Bronchial Thermoplasty with the Alair System |
| Control | Active comparator | Standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤30 mg/day. Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Adverse Events Per Subject
Respiratory adverse events (AEs) per subject reported during the Treatment Period, and Post-Treatment Period (Steroid Stable Phase, and Steroid Wean and Reduced Steroid Phase). Results were calculated by dividing the number of respiratory adverse events during each time period by the number of subjects in each group. Statistics were not calculated.
Measured: Baseline, 12 Months
Secondary outcomes (7)
Use of Maintenance Medications (Change From Baseline)
Percent Change from Baseline at 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visit in dose of inhaled and/or oral corticosteroids.
Measured: Baseline, 12 Months
Use of Rescue Medications (Change From Baseline)
Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in use of rescue medications. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.
Measured: Baseline, 12 Months
Total Symptom Score (Change From Baseline)
Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Total Symptom Score. The Total Symptom Score comprises the sum of six asthma symptom measurements recorded in a Daily Diary. Each of these symptoms is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom Score represents better asthma control.
Measured: Baseline, 12 Months
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in forced expiratory volume in one second (FEV1). FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.
Measured: Baseline, 12 Months
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months(Steroid Wean and Reduced Steroid Phase) Follow-up Visits in forced expiratory volume in one second (FEV1). FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.
Measured: Baseline, 12 Months
Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Asthma Control Questionnaire (ACQ) score. The ACQ is a self-administered patient questionnaire that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient's asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (Better) to 6 (Worse). The ACQ is based on a one-week recall period. A decrease in the ACQ score indicates better asthma control.
Measured: Baseline, 12 Months
Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months(Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Asthma Quality of Life Questionnaire (AQLQ) score. The AQLQ is a self-administered patient questionnaire that assesses four aspects or domains of daily life for patients with asthma: symptoms, emotional function, activity limitations, and environmental stimuli. The AQLQ is based on a 2-week recall period and consists of 32 questions, each scored from 1 (Worse) to 7 (Better). An increase in the AQLQ score indicates a better quality of life.
Measured: Baseline, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionFeb 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Narinder S Shargill, PhD, Study director, Asthmatx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214539
- Sponsor's protocol ID
- Protocol #0903-27
- Status last verified
- Jan 2021
- First submitted
- 15 Sep 2005
- Last updated
- 11 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pavord 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 17901415
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Clinical Trial of Bronchial Thermoplasty With the Alair System for the Treatment of Severe Asthma
- ClinicalTrials.gov ID
- NCT00214539
- Acronym / sponsor ID
- Protocol #0903-27
- Conditions
- Asthma
- Keywords
- Asthma, Bronchial Thermoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 7 Nov 2011
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 the safety and efficacy of the Alair System for the treatment of severe refractory asthma.
This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy in patients with severe asthma refractory to standard medication therapy. A total of 30 subjects will be randomized 1:1 to the Alair Group (Medical management + Alair Treatment) OR the Control Group (Medical management only).
Detailed description
Multicenter, randomized, clinical trial conducted at 8 Investigational Sites in 3 countries.
Subjects in the Alair group to be administered the Alair treatment in 3 separate bronchoscopy sessions, while subjects in the Control group will complete 3 "Control Visits" to the Physicians office, timed to coincide with the 3 treatment bronchoscopy sessions. Following completion of all three procedures or Control Visits subjects will be evaluated at 6 weeks and 12 weeks. All subjects to remain on their maintenance asthma medications until they are evaluated again at 22 weeks after the last procedure or Control Visit. This phase from the last procedure or Control Visit out to 22 Weeks after the last procedure or Control Visit is termed the Steroid Stable Phase.
Subjects will undergo a 14 week period from 22 Weeks to 36 Weeks (termed the Steroid Wean Phase) during which an attempt will be made to wean them off either their maintenance inhaled corticosteroids (ICS) or, if taking maintenance oral corticosteroids (OCS), their oral steroids. If a subject cannot tolerate the steroid reduction at a particular level (as evidenced by loss of asthma control), they will be stabilized on their last tolerable dose of steroid.
All subjects will maintain their reduced steroid dosage from the end of the Steroid Wean Phase at 36 weeks to their final evaluations at the end of the Study at 52 weeks (termed the Reduced Steroid Phase). All subjects will be exited from the study following completion of the 52 week evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Bronchial Thermoplasty with the Alair SystemAlair treatment plus standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤ 30 mg/day. |
| Control | Active comparator | Drug: ControlStandard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤30 mg/day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ambulatory adult; age 18-65 years
- Asthma requiring regular maintenance medication that includes high dose inhaled corticosteroid AND long acting β2 agonist (LABA) with or without other asthma maintenance medications. Oral prednisone ≤30 mg/day, leukotriene modifiers, theophylline or other asthma control drugs may be prescribed at the physician's discretion.
- Pre-bronchodilator forced expiratory volume in one second (FEV1) ≥50% predicted (patients stabilized on inhaled corticosteroids (ICS) and long acting β2 agonists)
- PC20 < 4 mg/ml per methacholine inhalation test using standardized methods, for patients with pre-bronchodilator FEV1 ≥60% predicted (or FEV1 > lower limit defined by individual hospital protocol). PC20 is the provocative concentration of Provocholine® (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from Baseline
- Reversible bronchoconstriction during the 12 months prior to enrollment, as demonstrated by an increase in FEV1 of at least 12% 30 minutes after 4 puffs of short-acting β2 agonist, for patients with pre-bronchodilator FEV1 < 60% predicted (or FEV1 < lower limit defined by individual hospital protocol)
Key exclusion criteria (16 listed)
- Participation in another clinical trial involving respiratory intervention that could affect the outcome measures of this study, within 6 weeks prior to randomization. Patients will be disqualified from the study if they enter another study or fail to comply with prescribed asthma medications.
- Use of immunosuppressant therapy (e.g., methotrexate).
- Current or recent lower respiratory tract infection (resolved less than 6 weeks from enrollment testing)
- History of recurrent (no more than three in the last three months) lower respiratory tract infection requiring antibiotics
- Presence of other respiratory diseases including emphysema, cystic fibrosis, vocal cord dysfunction, mechanical upper airway obstruction, obstructive sleep apnea, Churg-Strauss syndrome, cardiac dysfunction, allergic bronchopulmonary aspergillosis
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 |
|---|---|---|
| Bronchial Thermoplasty with the Alair SystemAlso: Alair SystemAlair treatment plus standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤ 30 mg/day. | Procedure or surgery | Treatment |
| ControlStandard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤30 mg/day. | Drug | Control |
Primary outcome
Respiratory Adverse Events Per Subject
Time frame: Baseline, 12 Months
Respiratory adverse events (AEs) per subject reported during the Treatment Period, and Post-Treatment Period (Steroid Stable Phase, and Steroid Wean and Reduced Steroid Phase). Results were calculated by dividing the number of respiratory adverse events during each time period by the number of subjects in each group. Statistics were not calculated.
7 secondary outcomes
Use of Maintenance Medications (Change From Baseline)
Time frame: Baseline, 12 Months
Use of Rescue Medications (Change From Baseline)
Time frame: Baseline, 12 Months
Total Symptom Score (Change From Baseline)
Time frame: Baseline, 12 Months
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Time frame: Baseline, 12 Months
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Time frame: Baseline, 12 Months
Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
Time frame: Baseline, 12 Months
Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
Time frame: Baseline, 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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.
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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.
Narinder S Shargill, PhD study director
Asthmatx, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchial Thermoplasty with the Alair System in people with Asthma, run by Boston Scientific Corporation.
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 12 inclusion and 16 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 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 7 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Respiratory Adverse Events Per Subject (time frame: Baseline, 12 Months). 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 NCT00214539, which also lists 1 linked publication.
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 11 Feb 2021.