N/A N=112 Randomized Treatment

Asthma Intervention Research (AIR) Trial

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00214526 ↗

Enrolled (actual)

112

Serious AEs

7.8%

Results posted

Oct 2010

Primary outcome: Primary: Mild Exacerbation Rate (OFF-LABA) (Change From Baseline) — -0.16; 0.04 Exacerbations/Subject/Week

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Bronchial thermoplasty with the Alair System (Procedure); Conventional therapy with ICS+LABA (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Asthmatx, Inc.
Primary completion: Jul 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Mild Exacerbation Rate (OFF-LABA) (Change From Baseline)	-0.16; 0.04	—
SECONDARY Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)	3.65; 0.32; 5.28; 4.00; 7.29; 5.17	—
SECONDARY Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)	-0.13; -0.13; 0.76; 0.80; 0.82; 0.13	—
SECONDARY Methacholine PC20 (Change From Baseline)	0.64; 0.37; 0.50; 0.42; 0.61; 0.50	—
SECONDARY Peak Expiratory Flow (Morning and Evening) (Change From Baseline)	27.96; 1.37; 42.59; 12.98; 31.49; 7.39	—
SECONDARY Asthma Control Questionnaire (ACQ) Score (Change From Baseline)	-0.30; -0.01; -1.15; -0.30; -1.23; -0.51	—
SECONDARY Use of Rescue Medications (Change From Baseline)	-3.62; 0.94; -9.08; -2.56; -5.84; -1.26	—
SECONDARY Use of Maintenance Medications (Change From Baseline)	52; 52; 1; 1; 2; 1	—
SECONDARY Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)	0.48; 0.01; 1.25; 0.29; 1.23; 0.54	—
SECONDARY Total Symptom Score (Change From Baseline)	-1.18; -0.33; -1.73; -0.37; -1.60; -0.66	—

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).

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00214526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.