Asthma Intervention Research 2 (AIR2) Trial
Summary
The objective of this randomized, double blind, sham-controlled study is to demonstrate the safety and effectiveness of the Alair System in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy of high doses of inhaled corticosteroids and long-acting β2-agonists.
The primary efficacy endpoint will be the difference between Study groups in the change in Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and follow-up visits.
This will be a multicenter, randomized, double-blind, sham-controlled study comparing the effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA).
A Bayesian adaptive approach to sample size selection is used with a randomization scheme of 2:1 (two Alair Group Subjects for every one Control Group Subject).
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Asthma
Intervention
Alair System, Alair System
Location
Pulmonary Associates, PA
Phoenix
Arizona
United States
85020
Status
Active, not recruiting
Source
Asthmatx, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00231114
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
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A group of enzymatic disorders affecting the nervous system and to a variable degree the skeletal system, lymphoreticular system, and other organs. The conditions are marked by an abnormal accumulation of catabolic material within lysosomes.
Endocrine System
The system of glands that release their secretions (hormones) directly into the circulatory system. In addition to the ENDOCRINE GLANDS, included are the CHROMAFFIN SYSTEM and the NEUROSECRETORY SYSTEMS.
Neuroimmunomodulation
The biochemical and electrophysiological interactions between the NERVOUS SYSTEM and IMMUNE SYSTEM that result in regulation of the immune system by the nervous system.
Dye Dilution Technique
Method for assessing flow through a system by injection of a known quantity of dye into the system and monitoring its concentration over time at a specific point in the system. (From Dorland, 28th ed)
Radioisotope Dilution Technique
Method for assessing flow through a system by injection of a known quantity of radionuclide into the system and monitoring its concentration over time at a specific point in the system. (From Dorland, 28th ed)
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