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Completed

NCT Number: NCT01350414

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

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%.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • None.

Treatment and study plan

Bronchial Thermoplasty with the Alair System

Device

Bronchial Thermoplasty with the Alair System

Primary outcomes

  1. Severe Exacerbations

    Time frame: 12 month periods out to 5 Years

    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 outcomes

  1. Severe Exacerbations

    Time frame: 12 Month periods out to 5 years

    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).

  2. Respiratory Adverse Events

    Time frame: 12 Month periods out to 5 years

    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.

  3. Respiratory Adverse Events

    Time frame: 12 Month periods out to 5 years

    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.

  4. Emergency Room Visits for Respiratory Symptoms

    Time frame: 12 Month periods out to 5 years

    Proportion of Subjects with Emergency Room Visits for Respiratory Symptoms

  5. Emergency Room (ER) Visits for Respiratory Symptoms

    Time frame: 12 Month periods out to 5 years

    Number of Emergency Room Visits for Respiratory Symptoms per subject per year.

  6. Hospitalizations for Respiratory Symptoms

    Time frame: 12 Month periods out to 5 Years

    Proportion of subjects with hospitalizations for respiratory symptoms.

  7. Hospitalizations for Respiratory Symptoms

    Time frame: 12 Month periods out to 5 years

    Number of Hospitalizations for Respiratory Symptoms per subject per year.

  8. Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: 12 Month periods out to 5 years

    Pre-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.

  9. Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: 12 Month periods out to 5 years

    Post-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: PAS1

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
May 9, 2011
Registry last updated
Sep 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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