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NCT01350336 · ClinicalTrials.gov registry record · NA

Bronchial Thermoplasty in Severe Persistent Asthma

A NA study, sponsored by Boston Scientific Corporation.

Completed
Registry status
NA
Development phase
284
Enrollment target

NCT01350336: Completed NA study, sponsored by Boston Scientific Corporation.

NCT01350336 is a NA study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 284 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01350336, a NA study, has completed, sponsored by Boston Scientific Corporation.

COMPLETED
Registry status
NA
Development phase
284 participants
Enrollment target

Study Summary

As Conditions of Approval of the PMA for the Alair System, the FDA requires Boston Scientific to generate data to assess the durability of the BT treatment effect as well as safety data in the intended use population in the United States.

Primary Outcome

The primary endpoint will be the proportion of subjects experiencing severe exacerbations during the subsequent 12-month (for Years 2, 3, 4, and 5) compared to the first 12-month after the Alair treatment.

Interventions

  • DEVICE Alair System

Trial Details

FieldValue
Enrollment Target 284 participants
Start Date 2011-04-07
Est. Completion 2020-03-17
Phase NA
Boston Scientific Corporation

280 total trials

What the finished NCT01350336 record still lists

NCT01350336 is an interventional study that assigns participants to a tested intervention. The registered 284 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 1 intervention - of which Alair System is the first listed.

NCT01350336 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01350336 about?

NCT01350336 is a clinical study titled "Bronchial Thermoplasty in Severe Persistent Asthma". As Conditions of Approval of the PMA for the Alair System, the FDA requires Boston Scientific to generate data to assess the durability of the BT treatment effect as well as safety data in the intended use population in the United States.

What is the current status of trial NCT01350336?

This trial is currently completed. It is a NA study. The enrollment target is 284 participants. The study started on 2011-04-07. Estimated completion is 2020-03-17.

What interventions are being tested in trial NCT01350336?

The interventions under investigation include: Alair System (DEVICE).

Who is sponsoring clinical trial NCT01350336?

This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01350336's enrollment target sits among peer trials

284 377th of 2000 higher than 1,623 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01350336, the US trial registry maintained by the National Library of Medicine. NCT01350336 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.