Trial record 1 of 1 for:    NCT01350336
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Bronchial Thermoplasty in Severe Persistent Asthma (PAS2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Asthmatx, Inc.
ClinicalTrials.gov Identifier:
NCT01350336
First received: April 15, 2011
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

As Conditions of Approval of the PMA for the Alair System, the FDA requires Asthmatx 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.


Condition Intervention Phase
Severe Asthma
Device: Alair System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma

Resource links provided by NLM:


Further study details as provided by Asthmatx, Inc.:

Primary Outcome Measures:
  • Subjects experiencing severe exacerbations [ Time Frame: Year 1 vs. Year 2, 3, 4, 5 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Rates of Severe exacerbations [ Time Frame: Year 1-5 ] [ Designated as safety issue: Yes ]
    (exacerbations / subject / year)

  • Respiratory adverse events [ Time Frame: Year 1-5 ] [ Designated as safety issue: Yes ]
    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: Year 1-5 ] [ Designated as safety issue: Yes ]
    Emergency room visits for respiratory symptoms (rates of emergency room visits)

  • Emergency room visits for respiratory symptoms [ Time Frame: Year 1-5 ] [ Designated as safety issue: Yes ]
    Emergency room visits for respiratory symptoms (proportion of subjects with emergency room visits for respiratory symptoms)

  • Hospitalizations for respiratory symptoms [ Time Frame: Year 1-5 ] [ Designated as safety issue: Yes ]
    (hospitalizations/ subject/ year)

  • Hospitalizations for respiratory symptoms [ Time Frame: Year 1-5 ] [ Designated as safety issue: Yes ]
    (the proportion of subjects with hospitalizations for respiratory symptoms)

  • Respiratory Serious Adverse Events [ Time Frame: Year 1-5 ] [ Designated as safety issue: Yes ]
    Pre-bronchodilator FEV1

  • Respiratory Serious Adverse Events [ Time Frame: Year 1-5 ] [ Designated as safety issue: Yes ]
    Post-bronchodilator FEV1


Estimated Enrollment: 300
Study Start Date: April 2011
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alair Device: Alair System
Treatment of airways with the Alair System

Detailed Description:

This is a multicenter, open-label, single arm study designed to demonstrate durability of the treatment effect and to evaluate the short-term and longer-term safety profile of the Alair System in the United States in the intended use population (patients 18 years and older with severe persistent asthma).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is an adult between the ages of 18 to 65 years.
  2. Subject is able to read, understand, and sign a written Informed Consent to participate in the study and able to comply with the study protocol.
  3. Subject has asthma and is taking regular maintenance medication that includes:

    1. Inhaled corticosteroid (ICS) at a dosage greater than 1000μg beclomethasone per day or equivalent, AND long acting β2-agonist (LABA) at a dosage of ≥80μg per day Salmeterol or equivalent.
    2. Other asthma medications such as leukotriene modifiers, or anti-IgE, are acceptable (Subjects on Xolair® must have been on Xolair for greater than 1 year).
    3. Oral corticosteroids (OCS) at a dosage of up to, but not greater than 10mg per day are acceptable.*
  4. Subject has a pre-bronchodilator FEV1 of greater than or equal to 60% of predicted.
  5. Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
  6. Subject is able to undergo outpatient (same day) bronchoscopy in the opinion of the investigator or per hospital guidelines.
  7. Subject has at least 2 days of asthma symptoms in the last 4 weeks.
  8. Subject has an AQLQ score during the baseline period of 6.25 or less.

    • NOTE: Subjects on a dosage regimen of 20mg OCS every other day may be included as this is equivalent to an average daily dosage of 10mg.

Exclusion Criteria:

  1. Subject is participating in another clinical trial within 6 weeks of the Baseline Period involving respiratory intervention that could affect the outcome measures of this Study.
  2. Over the last 7 days of a 4 week medication stable period, subject requirement for rescue medication use other than for prophylactic use for exercise exceeds an average of:

    1. 8 puffs per day of short-acting bronchodilator, or
    2. 4 puffs per day of long-acting rescue bronchodilator, or
    3. 2 nebulizer treatments per day. At the discretion of the Principal Investigator, subjects considered as unstable on baseline medications may have medications adjusted and re-evaluated after a 4 week medication stabilization period.
  3. Subject has a post-bronchodilator FEV1 of less than 65%.
  4. Subject has a history of life-threatening asthma, defined by past intubation for asthma, or ICU admission for asthma within the prior 2 years.
  5. Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year.
  6. Subject has had 4 or more infections of lower respiratory tract (LRTI) requiring antibiotics in the past 12 months.
  7. Subject has had 4 or more pulses of systemic corticosteroids (tablets, suspension or injection) for asthma symptoms in the past 12 months.
  8. Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
  9. Subject has other respiratory diseases including emphysema, cystic fibrosis, vocal cord dysfunction, mechanical upper airway obstruction, Churg-Strauss syndrome, and allergic bronchopulmonary aspergillosis (asthma, immediate cutaneous reactivity to A. fumigatus, total serum IgE of >1000ng/mL, elevated specific IgE and IgG to A. fumigatus with or without evidence of central bronchiectasis).
  10. Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray.
  11. Subject currently has clinically significant cardiovascular disease, including myocardial infarction, angina, cardiac dysfunction, cardiac dysrhythmia, conduction defect, cardiomyopathy, or stroke.
  12. Subject has a known aortic aneurysm.
  13. Subject has significant co-morbid illness such as cancer, renal failure, liver disease, or cerebral vascular disease.
  14. Subject has uncontrolled hypertension (>200mm Hg systolic or >100mm Hg diastolic pressure).
  15. Subject has an implanted electrical stimulation device (e.g., a pacemaker, cardiac defibrillator, or deep nerve or deep brain stimulator).
  16. Subject has coagulopathy (INR > 1.5).
  17. Subject has any other medical condition that would make them inappropriate for study participation, in the Investigator's opinion.
  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: NCT01350336

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Sponsors and Collaborators
Asthmatx, Inc.
Boston Scientific Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Asthmatx, Inc.
ClinicalTrials.gov Identifier: NCT01350336     History of Changes
Other Study ID Numbers: 10-02
Study First Received: April 15, 2011
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 22, 2014