AIR2 Extension Study to Demonstrate Longer-term (> 1 Year) Durability of Effectiveness

Asthma Clinical Trial

— PAS1  

Official title:

AIR2 Extension Study to Demonstrate Longer-term (> 1 Year) Durability of Effectiveness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350414
• Other study ID #: 10-01
• Status: Completed
• Phase: N/A
• First received: October 28, 2010
• Last updated: March 28, 2014
• Start date: October 2005
• Est. completion date: December 2012

Study information

• Verified date: March 2014
• Source: Asthmatx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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%.

Description:

This will be an open-label, single arm study designed to demonstrate the durability of effectiveness (beyond one year) of the Alair System in patients with severe persistent asthma.

Durability of treatment effect will be evaluated by comparison of the proportion of subjects experiencing severe exacerbations during the first year after the Alair treatment to subsequent 12-month periods out to 5 years.

The 12-month periods will begin 6 weeks post-last Alair bronchoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• All Alair group subjects who have participated in the AIR2 Trial 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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Bronchial Thermoplasty with the Alair System
Bronchial Thermoplasty with the Alair System

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Asthmatx, Inc.	Boston Scientific Corporation

References & Publications (3)

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, Ja — View Citation

Cox G, Thomson NC, Rubin AS, Niven RM, Corris PA, Siersted HC, Olivenstein R, Pavord ID, McCormack D, Chaudhuri R, Miller JD, Laviolette M; AIR Trial Study Group. Asthma control during the year after bronchial thermoplasty. N Engl J Med. 2007 Mar 29;356(13):1327-37. — View Citation

Wechsler ME, Laviolette M, Rubin AS, Fiterman J, Lapa e Silva JR, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Hales JB, McEvoy C, Slebos DJ, Holmes M, Phillips MJ, Erzurum SC, Hanania NA, Sumino K, Kraft M, Cox G, Sterman DH — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe Exacerbations	The primary endpoint will be the proportion of subjects experiencing severe exacerbations during the first year after the Alair treatment compared to subsequent 12-month periods out to 5 years.	12 month periods out to 5 Years	Yes
Secondary	Severe Exacerbations	Severe exacerbation rates (exacerbations / subject / year).	12 Month periods out to 5 years	Yes
Secondary	Respiratory adverse events	Rates of respiratory adverse events, and proportion of subjects with respiratory adverse events.	12 Month periods out to 5 years	Yes
Secondary	Emergency room visits for respiratory symptoms	Rates of emergency room visits, and proportion of subjects with emergency room visits for respiratory symptoms.	12 Month periods out to 5 years	Yes
Secondary	Hospitalizations for respiratory symptoms	Rates of hospitalizations, and proportion of subjects with hospitalizations for respiratory symptoms.	12 Month periods out to 5 Years	Yes
Secondary	Forced Expiratory Volume in 1 second (FEV1).		12 Month periods out to 5 years	Yes