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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01350414




Registration number
NCT01350414
Ethics application status
Date submitted
28/10/2010
Date registered
9/05/2011
Date last updated
26/09/2016

Titles & IDs
Public title
AIR2 Extension Study to Demonstrate Longer-term (> 1 Year) Durability of Effectiveness
Scientific title
AIR2 Extension Study to Demonstrate Longer-term (> 1 Year) Durability of Effectiveness
Secondary ID [1] 0 0
10-01
Universal Trial Number (UTN)
Trial acronym
PAS1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Bronchial Thermoplasty with the Alair System

Alair Group - Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02, NCT00231114)


Treatment: Devices: Bronchial Thermoplasty with the Alair System
Bronchial Thermoplasty with the Alair System
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Severe Exacerbations
Timepoint [1] 0 0
12 month periods out to 5 Years
Secondary outcome [1] 0 0
Severe Exacerbations
Timepoint [1] 0 0
12 Month periods out to 5 years
Secondary outcome [2] 0 0
Respiratory Adverse Events
Timepoint [2] 0 0
12 Month periods out to 5 years
Secondary outcome [3] 0 0
Respiratory Adverse Events
Timepoint [3] 0 0
12 Month periods out to 5 years
Secondary outcome [4] 0 0
Emergency Room Visits for Respiratory Symptoms
Timepoint [4] 0 0
12 Month periods out to 5 years
Secondary outcome [5] 0 0
Emergency Room (ER) Visits for Respiratory Symptoms
Timepoint [5] 0 0
12 Month periods out to 5 years
Secondary outcome [6] 0 0
Hospitalizations for Respiratory Symptoms
Timepoint [6] 0 0
12 Month periods out to 5 Years
Secondary outcome [7] 0 0
Hospitalizations for Respiratory Symptoms
Timepoint [7] 0 0
12 Month periods out to 5 years
Secondary outcome [8] 0 0
Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Timepoint [8] 0 0
12 Month periods out to 5 years
Secondary outcome [9] 0 0
Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Timepoint [9] 0 0
12 Month periods out to 5 years

Eligibility
Key inclusion criteria
- All Alair group subjects who have participated in the AIR2 Trial (NCT00231114) and
were not lost to follow-up at the end of the 12 month premarket visit, and those who
are willing to comply with the study protocol and routine visits for the duration of
the study will be included in the post-approval study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- None.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
181
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to evaluate durability of effectiveness (beyond one year) of
the Alair System in patients with severe persistent asthma. The study will consist of
Alair-group subjects who are currently in the follow-up phase (out to 5 years) of the AIR2
Trial (Protocol #04-02, clinicaltrials.gov number NCT00231114).

Durability of the treatment effect will be evaluated by comparing the proportion of subjects
who experience severe exacerbations during the first year after Alair treatment with the
proportion of subjects who experience severe exacerbations during subsequent 12 month periods
out to 5 years.

All Alair group subjects in the AIR2 Trial are being followed out to 5 years as per the AIR2
Trial protocol. The data that are to be used to determine durability of effectiveness as
described in the present protocol (Protocol #10-01) are being collected under the existing
AIR2 Trial protocol (Protocol # 04-02).

Study Hypothesis: An empirical demonstration of the durability of the treatment effect will
be used to show that the proportion of subjects experiencing severe exacerbations for the
first year compared with the proportions of subjects experiencing severe exacerbations in
subsequent years do not get substantially worse.

The primary statistical objective is to demonstrate that the proportion of subjects who
experience severe exacerbations in the subsequent 12-month follow-up (for Year 2, Year 3,
Year 4 and Year 5 [in 12-month periods]) is not statistically worse when compared with the
proportion of first 12-months, which begins 6-weeks after the last Alair treatment. This
objective will be met if the upper 95% confidence limit of the difference in proportions
(i.e., the subsequent 12-month proportion minus the first 12-month proportion) is less than
20%.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01350414
Trial related presentations / publications
Castro M, Rubin AS, Laviolette M, Fiterman J, De Andrade Lima M, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Duhamel DR, McEvoy C, Barbers R, Ten Hacken NH, Wechsler ME, Holmes M, Phillips MJ, Erzurum S, Lunn W, Israel E, Jarjour N, Kraft M, Shargill NS, Quiring J, Berry SM, Cox G; AIR2 Trial Study Group. Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. Am J Respir Crit Care Med. 2010 Jan 15;181(2):116-24. doi: 10.1164/rccm.200903-0354OC. Epub 2009 Oct 8.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Narinder S Shargill, PhD
Address 0 0
Asthmatx, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries