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AIR2 Extension Study to Demonstrate Longer-term (> 1 Year) Durability of Effectiveness (PAS1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01350414
First received: October 28, 2010
Last updated: August 3, 2016
Last verified: August 2016
  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, 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%.


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

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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. 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%.

    Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02).



Secondary Outcome Measures:
  • Severe Exacerbations [ Time Frame: 12 Month periods out to 5 years ] [ Designated as safety issue: Yes ]
    Number of severe exacerbations per subject per year. Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02).

  • Respiratory Adverse Events [ Time Frame: 12 Month periods out to 5 years ] [ Designated as safety issue: Yes ]
    Number of respiratory adverse events per subject per year. A respiratory adverse event is defined as any sign, symptom, illness, clinically significant abnormal laboratory value, or other adverse medical event associated with the "Respiratory System" that appears or worsens in a subject during a clinical study, regardless of whether or not it is considered related to the procedure used as part of the protocol.

  • Respiratory Adverse Events [ Time Frame: 12 Month periods out to 5 years ] [ Designated as safety issue: Yes ]
    Proportion of subjects experiencing one or more respiratory adverse event in each of the years 1 through 5 following the Alair treatment. A respiratory adverse event is defined as any sign, symptom, illness, clinically significant abnormal laboratory value, or other adverse medical event associated with the "Respiratory System" that appears or worsens in a subject during a clinical study, regardless of whether or not it is considered related to the procedure used as part of the protocol.

  • Emergency Room Visits for Respiratory Symptoms [ Time Frame: 12 Month periods out to 5 years ] [ Designated as safety issue: Yes ]
    Proportion of Subjects with Emergency Room Visits for Respiratory Symptoms

  • Emergency Room (ER) Visits for Respiratory Symptoms [ Time Frame: 12 Month periods out to 5 years ] [ Designated as safety issue: Yes ]
    Number of Emergency Room Visits for Respiratory Symptoms per subject per year.

  • Hospitalizations for Respiratory Symptoms [ Time Frame: 12 Month periods out to 5 Years ] [ Designated as safety issue: Yes ]
    Proportion of subjects with hospitalizations for respiratory symptoms.

  • Hospitalizations for Respiratory Symptoms [ Time Frame: 12 Month periods out to 5 years ] [ Designated as safety issue: Yes ]
    Number of Hospitalizations for Respiratory Symptoms per subject per year.

  • Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 12 Month periods out to 5 years ] [ Designated as safety issue: Yes ]
    Pre-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.

  • Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 12 Month periods out to 5 years ] [ Designated as safety issue: Yes ]
    Post-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.


Enrollment: 181
Study Start Date: October 2005
Study Completion Date: December 2012
Primary Completion Date: September 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, NCT00231114)
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   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350414

Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Narinder S Shargill, PhD Asthmatx, Inc.
  More Information

Publications:
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01350414     History of Changes
Other Study ID Numbers: 10-01 
Study First Received: October 28, 2010
Results First Received: June 17, 2015
Last Updated: August 3, 2016
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on December 02, 2016