Stimulation of the Cervical Sympathetic Ganglion for Treatment of Asthma

Completed · Not applicable

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01724307

Run by

Jonathan Parsons

People needed

1

Starts

2011-09-01

Expected to finish

2013-11-01

Last updated by the study team

2016-01-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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
• Evidence of coagulopathy with abnormal INR, PT/ PTT and platelet count
• Subjects allergic to lidocaine (Subject may still participate in the study if they agree to the procedure without using the Lidoderm patch)
• Subjects participating in another interventional research trial
• Subjects with a condition or compliance issue, which in the investigator's opinion might interfere with participation in the current study
• Subjects unable or unwilling to provide a written consent to undergo the required testing/ procedures/ physical exam or answer the questionnaires

Where it is running

• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.