AIR2 Extension Study to Demonstrate Longer-term (> 1 Year) Durability of Effectiveness (PAS1)
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Purpose
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%.
| Condition | Intervention |
|---|---|
|
Asthma |
Device: Bronchial Thermoplasty with the Alair System |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | AIR2 Extension Study to Demonstrate Longer-term (> 1 Year) Durability of Effectiveness |
- Severe Exacerbations [ Time Frame: 12 month periods out to 5 Years ] [ Designated as safety issue: Yes ]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.
- Severe Exacerbations [ Time Frame: 12 Month periods out to 5 years ] [ Designated as safety issue: Yes ]Severe exacerbation rates (exacerbations / subject / year).
- Respiratory adverse events [ Time Frame: 12 Month periods out to 5 years ] [ Designated as safety issue: Yes ]Rates of respiratory adverse events, and proportion of subjects with respiratory adverse events.
- Emergency room visits for respiratory symptoms [ Time Frame: 12 Month periods out to 5 years ] [ Designated as safety issue: Yes ]Rates of emergency room visits, and proportion of subjects with emergency room visits for respiratory symptoms.
- Hospitalizations for respiratory symptoms [ Time Frame: 12 Month periods out to 5 Years ] [ Designated as safety issue: Yes ]Rates of hospitalizations, and proportion of subjects with hospitalizations for respiratory symptoms.
- Forced Expiratory Volume in 1 second (FEV1). [ Time Frame: 12 Month periods out to 5 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 181 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Alair Group
Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02)
|
Device: Bronchial Thermoplasty with the Alair System
Bronchial Thermoplasty with the Alair System
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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:
- None.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Asthmatx, Inc. |
| ClinicalTrials.gov Identifier: | NCT01350414 History of Changes |
| Other Study ID Numbers: | 10-01 |
| Study First Received: | October 28, 2010 |
| Last Updated: | July 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 13, 2013