NCT01724307

Brief Summary

The purpose of this study is to evaluate if stimulating the nerve involved with airway constriction, while undergoing procedures that are known to cause asthma exacerbations, decreases the level of asthma attack experienced.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 9, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

2.2 years

First QC Date

October 9, 2012

Last Update Submit

January 25, 2016

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Evaluate if neurostimulation of stellate ganglion modulates airway hyperresponsiveness to bronchoprovocation testing. Comparison of FEV1 drop before and after neurostimulation testing will be primary outcome measure

    To determine whether neurostimulation of the stellate ganglion modulates airway hyperresponsiveness to bronchoprovocation testing in asthmatics

    60 minutes post treatment

Secondary Outcomes (1)

  • Evaluate if neurostimulation of the stellate ganglion modulates airway inflammation

    60 minutes post treatment

Study Arms (2)

Asthma positive to Methacholine Challenge Testing

ACTIVE COMPARATOR

Asthma diagnosis by positive Methacholine Challenge Testing

Procedure: Neurostimulation of stellate ganglion

Asthma positive to Eucapnic voluntary hyperventilation testing

ACTIVE COMPARATOR

Asthma diagnosis by positive Eucapnic voluntary hyperventilation testing

Procedure: Neurostimulation of stellate ganglion

Interventions

Neurostimulation of stellate ganglionPROCEDURE

An electrical nuerostimulation of the stellate ganglion up to 60 minutes

Asthma positive to Eucapnic voluntary hyperventilation testingAsthma positive to Methacholine Challenge Testing

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients aged 18-70 years of age suffering from mild-to-moderate asthma who have either:
  • bronchial hyper-responsiveness to MCT
  • bronchial hyper-responsiveness to EVH testing
  • All patients with documented evidence of a positive MCT or EVH test within 36 months of Visit 1
  • Are capable of reading and understanding questionnaires and providing written informed consent.
  • Are willing and able to adhere to the study visit schedule and other protocol-specified procedures.

You may not qualify if:

  • Non-English speaking.
  • Subjects experiencing an exacerbation of asthma within 6 weeks of Visit 1
  • Subjects with a forced expiratory volume (FEV1) ≤ 60% predicted, on spirometry
  • Subjects and medications:
  • Subjects allergic to methacholine or any other parasympathomimetic agent
  • Subjects on investigational drugs or participating in interventional research trial(s), 30 days prior to enrollment or during the duration of the study
  • Subjects currently on β-adrenergic blockers or, a cholinesterase inhibitor
  • Prior to the administering of the MCT/ EVH test:
  • i) use of a short-acting bronchodilator (within 6hrs.) ii) use of a long-acting bronchodilator (within 36hrs.) iii) use of inhaled corticosteroids/ leukotriene modifiers (within 72hrs.) iv) exercise (within 4hrs.)
  • Subject smoking: in the last 6 months or a smoking history of \>10 pack-years
  • Subjects who have experienced a febrile illness within 3 weeks of Visit 1
  • Subjects with a history of active poorly controlled epilepsy, cardiovascular disease (esp. with bradycardia), vagotonia, peptic ulcer disease, thyroid disease, or urinary tract obstruction or other chronic ailments that would interfere with the current study
  • Subjects who are pregnant or refuse medically acceptable contraception during the study period
  • Subjects with a history of \>3 stellate ganglion block procedures
  • Subjects who have undergone surgical procedures involving the cervical spine
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jonathan P Parsons, M.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 9, 2012

First Posted

November 9, 2012

Study Start

September 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

US(1)