Asthma Intervention Research (AIR) Trial

NCT00214526 | Completed Results DMC

• 1 other identifier: Protocol #0602-20
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Asthma

Keywords

Asthma; Bronchial Thermoplasty; Airway Hyperresponsiveness

Outcome Measures

Primary Outcomes (1)

• Mild Exacerbation Rate (OFF-LABA) (Change From Baseline)

  Average change from Baseline across 12-Week, 6-Month, and 12-Month (OFF-LABA) Follow-up visits. A mild exacerbation was defined as 2 consecutive days when at least one of the following occurs: 1. Morning peak expiratory flow falls at least 20% below the average morning peak flow recorded during the 7 days immediately prior to Enrollment testing; 2. More than 3 more puffs of rescue short acting bronchodilator are required than the average usage during the 7 days immediately prior to Enrollment testing; 3. Awakening at night with asthma symptoms.

  Baseline, 12 Months

Secondary Outcomes (9)

• Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)

  Baseline, 12 Months

• Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)

  Baseline, 12 Months

• Methacholine PC20 (Change From Baseline)

  Baseline, 12 Months

• Peak Expiratory Flow (Morning and Evening) (Change From Baseline)

  Baseline, 12 Months

• Asthma Control Questionnaire (ACQ) Score (Change From Baseline)

  Baseline, 12 Months

Study Arms (2)

Alair Group

EXPERIMENTAL

Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System.

Procedure: Bronchial thermoplasty with the Alair System

Control Group

ACTIVE COMPARATOR

Conventional therapy with ICS+LABA.

Drug: Conventional therapy with ICS+LABA

Interventions

Bronchial thermoplasty with the Alair System PROCEDURE

Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System.

Alair Group

Conventional therapy with ICS+LABA DRUG

Conventional therapy with ICS+LABA.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asthmatx, Inc.: lead

Related Publications (1)

• Cox G, Thomson NC, Rubin AS, Niven RM, Corris PA, Siersted HC, Olivenstein R, Pavord ID, McCormack D, Chaudhuri R, Miller JD, Laviolette M; AIR Trial Study Group. Asthma control during the year after bronchial thermoplasty. N Engl J Med. 2007 Mar 29;356(13):1327-37. doi: 10.1056/NEJMoa064707.

  PMID: 17392302 DERIVED

MeSH Terms

Conditions

Asthma; Respiratory Hypersensitivity

Interventions

Bronchial Thermoplasty

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Catheter Ablation; Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Mark G. Grubb
• Organization: Boston Scientific Corporation

Mark.Grubb@bsci.com

412-749-1423

Study Officials

• Narinder S Shargill, PhD

  Asthmatx, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2002
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: August 28, 2015
• Results First Posted: October 18, 2010

Record last verified: 2015-08