Asthma3to2NCT00803088
Safety of Bronchial Thermoplasty Performed With the Alair® System During Two Treatment Sessions to Treat Severe Asthma
A study testing The Alair System in people with Asthma, run by Boston Scientific Corporation.
Trial summary
The objective of this multicenter, single-arm, open-label clinical study is to evaluate the safety of performing bronchial thermoplasty with the Alair® System during two treatment sessions to treat severe asthma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- The Alair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is an adult between the ages of 18 to 70 years.
- Subject is able to read, understand, and sign a written Informed Consent form to participate in the Study.
- Subject has asthma and is taking maintenance asthma medication that includes:
- Inhaled corticosteroid (ICS) at a dosage ≥1000μg beclomethasone per day or equivalent, AND long acting β2-agonist (LABA) at a dosage of ≥100μg per day Salmeterol or equivalent.
- Other asthma medications such as leukotriene modifiers, or anti-IgE, are acceptable (Subjects on Xolair® must have been on Xolair for greater than 1 year).
- Oral corticosteroids (OCS) at a dosage up to, but not greater than, 10mg per day.
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- Subject has an AQLQ score at Baseline of 6.25 or less.
- Subject has a Pre-bronchodilator FEV1 of greater than or equal to 60% of predicted after medication stabilization during the Baseline Period.
- Subject has a PC20 < 8mg/ml per methacholine inhalation test using standardized methods*.
- Subject has at least one day of asthma symptoms during the 2 weeks of the Baseline Diary Period.
- Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
- Subject is able to undergo bronchoscopy in the opinion of the Investigator or per hospital guidelines.
- Subject is willing and able to comply with the Study protocol, attending follow-up visits, and requirements for taking and abstaining from medications.
Who cannot join
- Subject participated in another clinical trial within 6 weeks of the Baseline Period involving respiratory intervention that could affect the outcome measures of this Study.
- Subject requirement during the Baseline Diary period for rescue medication use other than for prophylactic use for exercise exceeds an average of:
- 8 puffs per day of short-acting bronchodilator, or
- 4 puffs per day of long-acting rescue bronchodilator, or
- 2 nebulizer treatments per day.
- Subject has a post-bronchodilator FEV1 of less than 65% of predicted.
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- Subject had three or more hospitalizations for exacerbations of asthma in the prior 12 months.
- Subject has a recent history of life-threatening asthma, defined by at least one intubation for asthma within the past five years.
- Subject had an ICU admission for asthma within the prior 24 months.
- Subject had four or more infections of the lower respiratory tract requiring antibiotics in the prior 12 months.
- Subject had four or more asthma exacerbations requiring oral steroid pulses in the prior 12 months.
- Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine, benzodiazepines, or other parasympathomimetic agents).
- Subject is undergoing immunosuppressant therapy other than steroids (e.g., methotrexate).
- Subject uses systemic beta-adrenergic blocking agents.
- Subject is an insulin-dependent diabetic.
- Subject is pregnant or a nursing mother, or has plans to become pregnant within the next 12 months.
- Subject has other respiratory diseases including interstitial lung disease, emphysema, cystic fibrosis, vocal cord dysfunction, mechanical upper airway obstruction, Churg-Strauss syndrome, or active allergic bronchopulmonary aspergillosis (current total IgE of >1000 Units/mL with positive specific IgE to aspergillus and evidence of central bronchiectasis).
- Subject has significant segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on X-ray.
- Subject has chronic sinus disease as defined by five or more episodes of sinusitis in past 12 months, or continuous symptoms of sinus infection (purulent discharge) and significant change in nasal steroid dosage in last six weeks.
- Subject has uncontrolled sleep apnea (sleep apnea not controlled by either dental appliances or continuous airway positive pressure (CPAP)).
- Subject has uncontrolled gastro-esophageal reflux disease as defined by a significant increase in therapy in last six weeks.
- Subject has lung cancer or a history of lung cancer.
- Subject currently has active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of the skin is acceptable.
- (Subject with a history of cancer (excluding lung cancer) and a five year or more disease free survival time may only be included in this Study by agreement of Sponsor on a case by case basis).
- Subject has a history of epilepsy.
- Subject currently has clinically significant cardiovascular or neurovascular disease, including myocardial infarction with congestive heart failure, angina, clinically significant cardiac dysrhythmia or conduction defect, cardiomegaly, cardiomyopathy, aortic aneurysm, cerebral vascular disease, or stroke.
- Subject is on anticoagulant therapy, has a bleeding diathesis, platelet dysfunction, or thrombocytopenia with platelet count less than 125,000/mm2 or known coagulopathy (INR > 1.5).
- Subject has uncontrolled hypertension (>200mm Hg systolic or >100mm Hg diastolic pressure).
- Subject has an electrical stimulation device such as a pacemaker, defibrillator, or deep nerve or deep brain stimulator.
- Subject has a psychiatric disorder that in the judgment of the Investigator could interfere with provision of Informed Consent, completion of tests, therapy, or follow-up visits.
- Subject has any other medical condition that in the Investigator's opinion would make them inappropriate for Study participation.
About this study
Official title: A Multicenter Clinical Trial Evaluating the Safety of Bronchial Thermoplasty Performed With the Alair® System During Two Treatment Sessions to Treat Severe Asthma.
The objective of this multicenter, single-arm, open-label clinical study is to evaluate the safety of performing bronchial thermoplasty with the Alair® System during two treatment sessions to treat severe asthma.
- Conditions
- Asthma
- Being tested
- The Alair System
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Alair SystemDevice
Treatment of airways with the Alair System
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment of airways with the Alair System Receives: Device: The Alair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Profile
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
Why it stopped: Current treatment regimen of 3 procedures considered acceptable.
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803088
- Sponsor's protocol ID
- 08-01
- Acronym
- 3to2
- Status last verified
- Jan 2021
- First submitted
- 4 Dec 2008
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This study was cancelled prior to initiation.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Trial Evaluating the Safety of Bronchial Thermoplasty Performed With the Alair® System During Two Treatment Sessions to Treat Severe Asthma.
- ClinicalTrials.gov ID
- NCT00803088
- Acronym / sponsor ID
- 3to2 / 08-01
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Current treatment regimen of 3 procedures considered acceptable.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- First posted
- 5 Dec 2008 (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 objective of this multicenter, single-arm, open-label clinical study is to evaluate the safety of performing bronchial thermoplasty with the Alair® System during two treatment sessions to treat severe asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: The Alair SystemTreatment of airways with the Alair System |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is an adult between the ages of 18 to 70 years.
- Subject is able to read, understand, and sign a written Informed Consent form to participate in the Study.
- Subject has asthma and is taking maintenance asthma medication that includes:
- Subject has an AQLQ score at Baseline of 6.25 or less.
- Subject has a Pre-bronchodilator FEV1 of greater than or equal to 60% of predicted after medication stabilization during the Baseline Period.
Key exclusion criteria (31 listed)
- Subject participated in another clinical trial within 6 weeks of the Baseline Period involving respiratory intervention that could affect the outcome measures of this Study.
- Subject requirement during the Baseline Diary period for rescue medication use other than for prophylactic use for exercise exceeds an average of:
- Subject has a post-bronchodilator FEV1 of less than 65% of predicted.
- Subject had three or more hospitalizations for exacerbations of asthma in the prior 12 months.
- Subject has a recent history of life-threatening asthma, defined by at least one intubation for asthma within the past five years.
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 |
|---|---|---|
| The Alair SystemTreatment of airways with the Alair System | Device | 1 |
Primary outcome
Adverse Event Profile
Time frame: 3 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: No. This study was cancelled prior to initiation.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 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 13 inclusion and 31 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: withdrawn, as of the sponsor's last update on 1 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Adverse Event Profile (time frame: 3 Months). 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 1 Feb 2021.