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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
Trial related presentations / publications
Public notes

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Wechsler ME, Laviolette M, Rubin AS, Fiterman J, L... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT01350414