N/A
Completed N=14
RISA Extension Study - Long Term Safety
Source: ClinicalTrials.gov NCT00401986 ↗Enrolled (actual)
14
Serious AEs
28.8%
Results posted
Feb 2021
Primary outcomePrimary: Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments — 78.6; 85.7; 83.3; 100 percentage subjects with respiratory AEs
Summary
The primary purpose of this study is to gather additional safety data for the subjects treated with the Alair System (hereinafter, "Alair-Treated Subjects") who previously completed the one-year study entitled: "Multicenter Randomized Clinical Trial of Bronchial Thermoplasty with the Alair System for the Treatment of Severe Asthma" (Protocol #0903-27) sponsored by Asthmatx, Inc. Subjects who elect to participate in this safety study will be followed for an additional four (4) year period beyond the PREDECESSOR STUDY'S one-year endpoint (clinicaltrials.gov number NCT00214539).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments |
78.6; 85.7; 83.3; 100 | — |
| PRIMARY Respiratory Adverse Events |
1.4; 2.4; 1.7; 2.4 | — |
| SECONDARY Hospitalizations for Respiratory Symptoms |
0.4; 0.2; 0.1; 0.1 | — |
| SECONDARY Emergency Room Visits for Respiratory Symptoms |
0.3; 0; 0; 0.1 | — |
Eligibility Criteria
Inclusion Criteria
- Subject who participated in the PREDECESSOR STUDY entitled "Multicenter Randomized Clinical Trial of Bronchial Thermoplasty with the Alair™ System for the Treatment of Severe Asthma" (Protocol # 0903-27).
- Subject was treated with the Alair System ("Alair Group") in the PREDECESSOR STUDY.
- Subject who is able to read, understand, and provide written Informed Consent.
- Subject who is able to comply with the study protocol, including requirements for taking and abstaining from medications, and complete all study required visits.
Exclusion Criteria
- Subject participating in another clinical trial involving respiratory intervention that could affect the outcome measures of this study, either within 6 weeks of study enrollment, or during the study period.
- Subject with a newly diagnosed (since exiting from the PREDECESSOR STUDY) psychiatric disorder which in the judgment of the investigator could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
Data sourced from ClinicalTrials.gov (NCT00401986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.