ANZCTR - Registration

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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]

10-01

Universal Trial Number (UTN)

Trial acronym

PAS1

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hemi Knee Arthroplasty

Asthma

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]

Treatment: Devices

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Severe Exacerbations

Timepoint [1]

12 month periods out to 5 Years

Secondary outcome [1]

Severe Exacerbations

Timepoint [1]

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?

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/study/NCT01350414

Trial related presentations / publications

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

Narinder S Shargill, PhD

Address

Asthmatx, Inc.

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

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

No documents have been uploaded by study researchers.

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

Trial Review

Registering a new trial?

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