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CompletedNCT00214539Updated Feb 11, 2021Results posted

Research in Severe Asthma (RISA) Trial

An interventional study of Bronchial Thermoplasty with the Alair System and Control in Asthma, sponsored by Boston Scientific Corporation. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-11.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • Bronchial Thermoplasty
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 34 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    1. Use of rescue medication (short-acting β2 agonist) at least 8 of the 14 days prior to enrollment OR
    2. 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Treatment

    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.

    Procedure: Bronchial Thermoplasty with the Alair System

  • Active comparator
    Control

    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.

    Drug: Control

Interventions

  • ProcedureBronchial Thermoplasty with the 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.

    Also known as: Alair System

  • DrugControl

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 12 Months

Secondary outcomes

  1. 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.

    Time frame: Baseline, 12 Months

  2. 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.

    Time frame: Baseline, 12 Months

  3. 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.

    Time frame: Baseline, 12 Months

  4. 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.

    Time frame: Baseline, 12 Months

  5. 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.

    Time frame: Baseline, 12 Months

  6. 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.

    Time frame: Baseline, 12 Months

  7. 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.

    Time frame: Baseline, 12 Months

07

Results

Posted Nov 6, 2011

Participant flow

Randomized
Participant flow — Randomized
MilestoneAlairControl
Started1717
Completed1517
Not completed20
Treatment Period
Participant flow — Treatment Period
MilestoneAlairControl
Started1517
Completed1517
Not completed00
Steroid Stable (Post-Tx to 22-Weeks)
Participant flow — Steroid Stable (Post-Tx to 22-Weeks)
MilestoneAlairControl
Started1517
Completed1517
Not completed00
Reduced Steroid (Post-SS to 52-Weeks)
Participant flow — Reduced Steroid (Post-SS to 52-Weeks)
MilestoneAlairControl
Started1517
Completed1517
Not completed00

Outcome measures

PrimaryRespiratory 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.

Time frame:
Baseline, 12 Months
Reported as:
Number · Respiratory Adverse Events/Subject
Respiratory Adverse Events Per Subject
Respiratory Adverse Events/SubjectAlairControl
Treatment Period9.13.4
Steroid Stable Phase2.62.2
Steroid Wean and Reduced Steroid Phase5.55.3
SecondaryUse 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.

Time frame:
Baseline, 12 Months
Reported as:
Mean · Percent
Use of Maintenance Medications (Change From Baseline)
PercentAlairControl
Oral Corticosteroids (OCS)-63.5 ± 45.4-26.2 ± 40.7
Inhaled Corticosteroids (ICS)-28.6 ± 30.4-20.0 ± 32.9
SecondaryUse 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.

Time frame:
Baseline, 12 Months
Reported as:
Mean · Puffs/7 Days
Use of Rescue Medications (Change From Baseline)
Puffs/7 DaysAlairControl
Steroid Stable Phase-26.56 ± 40.05-1.47 ± 11.66
Steroid Wean and Reduced Steroid Phase-25.56 ± 31.19-6.07 ± 12.43
SecondaryTotal 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.

Time frame:
Baseline, 12 Months
Reported as:
Mean · Units on a scale
Total Symptom Score (Change From Baseline)
Units on a scaleAlairControl
Steroid Stable Phase-1.75 ± 2.58-0.89 ± 1.84
Steroid Wean and Reduced Steroid Phase-1.37 ± 2.61-1.21 ± 1.63
SecondaryPre-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.

Time frame:
Baseline, 12 Months
Reported as:
Mean · Percent Change
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Percent ChangeAlairControl
Steroid Stable Phase14.91 ± 17.40-0.94 ± 22.34
Steroid Wean and Reduced Steroid Phase7.97 ± 19.131.89 ± 15.00
SecondaryPost-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.

Time frame:
Baseline, 12 Months
Reported as:
Mean · Percent Change
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Percent ChangeAlairControl
Steroid Stable Phase5.74 ± 8.56-0.82 ± 16.78
Steroid Wean and Reduced Steroid Phase2.76 ± 11.57-1.90 ± 11.97
SecondaryAsthma 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.

Time frame:
Baseline, 12 Months
Reported as:
Mean · Units on a scale
Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
Units on a scaleAlairControl
Steroid Stable Phase-1.04 ± 1.03-0.13 ± 1.00
Steroid Wean and Reduced Steroid Phase-0.99 ± 0.83-0.22 ± 0.78
SecondaryAsthma 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.

Time frame:
Baseline, 12 Months
Reported as:
Mean · Units on a scale
Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
Units on a scaleAlairControl
Steroid Stable Phase1.21 ± 1.050.15 ± 0.75
Steroid Wean and Reduced Steroid Phase1.53 ± 0.790.42 ± 0.82

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Alair (Treatment Period)—5/15 (33.3%)15/15 (100%)
Control (Treatment Period)—1/17 (5.9%)17/17 (100%)
Alair (Steroid Stable Phase)—4/15 (26.7%)15/15 (100%)
Control (Steroid Stable Phase)—1/17 (5.9%)15/17 (88.2%)
Alair (Steroid Wean and Reduced Steroid Phases)—2/15 (13.3%)15/15 (100%)
Control (Steroid Wean and Reduced Steroid Phases)—1/17 (5.9%)15/17 (88.2%)
Most frequent serious events
Most frequent serious events
EventAlair (Treatment Period)Control (Treatment Period)Alair (Steroid Stable Phase)Control (Steroid Stable Phase)Alair (Steroid Wean and Reduced Steroid Phases)Control (Steroid Wean and Reduced Steroid Phases)
DyspnoeaRespiratory, thoracic and mediastinal disorders3/150/171/150/170/151/17
Dyspnoea/WheezingRespiratory, thoracic and mediastinal disorders1/150/172/150/172/151/17
AtelectasisRespiratory, thoracic and mediastinal disorders1/150/170/150/170/150/17
Chest DiscomfortRespiratory, thoracic and mediastinal disorders1/150/170/150/170/150/17
CoughRespiratory, thoracic and mediastinal disorders1/150/170/150/170/150/17
Gallbladder PainHepatobiliary disorders1/150/170/150/170/150/17
HeadacheNervous system disorders0/150/171/150/170/150/17
Hernia RepairSurgical and medical procedures0/151/170/150/170/150/17
Respiratory FailureRespiratory, thoracic and mediastinal disorders0/150/170/151/170/150/17
Most frequent other events
Showing 10 of 128
Most frequent other events
EventAlair (Treatment Period)Control (Treatment Period)Alair (Steroid Stable Phase)Control (Steroid Stable Phase)Alair (Steroid Wean and Reduced Steroid Phases)Control (Steroid Wean and Reduced Steroid Phases)
CoughRespiratory, thoracic and mediastinal disorders11/156/172/154/176/154/17
WheezingRespiratory, thoracic and mediastinal disorders11/154/176/152/175/1510/17
DyspnoeaRespiratory, thoracic and mediastinal disorders9/155/175/157/178/1510/17
Productive CoughRespiratory, thoracic and mediastinal disorders8/154/172/154/178/151/17
Lower Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders2/155/172/152/176/152/17
Sputum DiscolouredRespiratory, thoracic and mediastinal disorders6/152/170/152/173/154/17
Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders1/153/173/151/176/154/17
Chest DiscomfortRespiratory, thoracic and mediastinal disorders4/151/171/152/172/156/17
Chest PainRespiratory, thoracic and mediastinal disorders5/151/170/150/171/151/17
Abdominal PainGastrointestinal disorders4/150/171/150/171/151/17

Baseline characteristics

Age, Continuous
Age, Continuous(years)AlairControlTotal
Mean39.13 ± 12.9742.06 ± 12.5740.69 ± 12.64
Sex: Female, Male
Sex: Female, Male(Participants)AlairControlTotal
Female9716
Male61016
Region of Enrollment
Region of Enrollment(participants)AlairControlTotal
Canada4610
United Kingdom10919
Brazil123
08

Study locations

No study locations are listed for this record.

09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00214539
Lead sponsor
Boston Scientific Corporation
First posted
Sep 22, 2005
Start date
Apr 2004
Primary completion
Feb 2006
Completion
Aug 2006
Results posted
Nov 6, 2011
Last update
Feb 11, 2021

Study contacts

Narinder S Shargill, PhD
study director · Asthmatx, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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