Asthma Intervention Research (AIR) Trial

Asthmatx

Status

Completed

Conditions

Asthma

Treatments

Drug: Conventional therapy with ICS+LABA

Procedure: Bronchial thermoplasty with the Alair System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00214526

Protocol #0602-20

Details and patient eligibility

About

The purpose of this study is to demonstrate the effectiveness and safety of the Alair System for the treatment of asthma.

This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy. One-hundred and ten subjects will be randomized 1:1 to either the Alair Group (Medical management + Alair treatment),or Control Group (Medical management only).

Full description

Multicenter, randomized, controlled clinical trial conducted at 11 Investigational Sites in 4 countries (Canada, United Kingdom, Denmark, and Brazil).

Subjects underwent Baseline evaluations, Alair treatments or Control Visits, and follow-up evaluations at 12-Weeks, 6-Months, and 12-Months after the last Treatment or Control Visit. In order to maximize the power of the study, Baseline and Follow-up testing was conducted in 2 parts. In the first part subjects continued to take their asthma maintenance medications (inhaled corticosteroids (ICS) and long acting β2-agonists (LABA) during the test period. This is designated as the "ON-LABA" Phase. Following ON-LABA testing subjects were asked to abstain from LABA for the second part of the testing, and these results are designated as the "OFF-LABA" Phase.

Enrollment

112 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ambulatory adult; age 18-65 years
Asthma requiring regular maintenance medication that includes inhaled corticosteroid (at least 200 μg beclomethasone per day or equivalent) AND long acting ß2 agonist (LABA) (at least 100 mg salmeterol per day or equivalent)
Pre-bronchodilator FEV1 60-85% (patients stabilized on inhaled corticosteroids and long acting β2 agonists)
PC20 < 8 mg/ml per methacholine inhalation test using standardized methods.
Demonstration of worsening of asthma following 2-week withdrawal of LABA, as documented by either:
an increase of at least 0.5 in the Juniper Asthma Control Questionnaire score, relative to the Questionnaire score in the 2 weeks preceding withdrawal of LABA, OR
a decline of at least 5% in the average am Peak Expiratory Flow during the second week of LABA abstinence relative to the average am Peak Expiratory Flow during the week immediately preceding LABA withdrawal
Non-smoker x 1 year or greater (if former smoker, less than 10 pack years total smoking history)
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

Participation in another clinical trial involving respiratory intervention that could affect the outcome measures of this study, either within 6 weeks of the pretreatment evaluation, or during the study period
Current or recent respiratory tract infection (resolved less than 6 weeks from pretreatment evaluation)
History of recurrent (³ 3 infections/year) lower respiratory tract infection requiring antibiotics.
With the exception of the use of a prophylactic bronchodilator for exercise, requirement for more than 4 puffs in a 24-hour period of a short-acting b2-adrenergic agonist such as albuterol or salbutamol 100 mg/puff or equivalent within the seven days immediately prior to commencement of Enrollment Testing, Part I.
Unstable asthma as defined by the need for an extra visit to a healthcare provider, increase in or introduction of new maintenance or symptom relieving medications (including new requirement for IV or nebulized medications) within 6 weeks of enrollment
Use of an internal or external pacemaker or internal cardiac defibrillator
Significant co-morbid illness such as cancer, renal failure, liver disease or cerebral vascular disease
POST-bronchodilator FEV1 of less than 65%.
Known systemic hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents
Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine and benzodiazepines
Use of a systemic b-adrenergic blocking agent
Pregnancy
Nursing mother
History of epilepsy
Cardiovascular disease, including bradycardia, angina, cardiac dysrhythmia, conduction defect or cardiac myopathy
Myocardial infarction or stroke within 6 months of the pretreatment evaluation
Any active disease left untreated,
Bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2 or known coagulopathy (INR > 1.5)
Use of anticoagulants
Insulin-dependent diabetes
Psychiatric disorder which in the judgement of the investigator could interfere with provision of informed consent, completion of tests, therapy, or follow-up
Presence of segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray
Interstitial lung disease
Uncontrolled hypertension (>200 mmHg systolic or >100mmHg diastolic pressure)
Known aortic aneurysm