Cough Desensitization Therapy: Pilot 2

Launched by UNIVERSITY OF MONTANA · Feb 4, 2022

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ClinConnect Summary

The study will be a randomized, placebo-controlled, blinded study. It will take place in three phases, across 10 weeks.

WEEK 1: BASELINE TESTING AND TRAINING (approximate time = 1 hour).

Cough sensitivity testing: Standardized procedures that have been established and approved by the FDA will be used to determine cough sensitivity. Participants will inhale capsaicin vapor (a known cough stimulant) through a nebulizer with dosimeter, that delivers a specific dose of capsaicin in a mist form. They will inhale doubling doses of capsaicin mist from .49 micromolar to 1000 micromolar. The testi...

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Eligibility criteria

• Inclusion Criteria:
• • At least 18 years of age
• • Currently suffering from a cough that started at least 8 weeks ago
• • Have seen at least one physician for the cough and have received medical treatment without success
• • Normal chest x-ray, pulmonary function testing (completed by your physician or a qualified speech-language pathologist).
• • Completion of a laryngoscopy (by ENT physician or qualified speech-language pathologist) with no evidence of an anatomical abnormality (i.e., masses or lesions such as nodules, cysts, or cancer) that could contribute to cough.
• • Willing to take a pregnancy test before enrollment (if applicable)
• • Willing to use contraception during the study (if applicable; we will not be able to supply you with contraceptive methods)
• • If you are diagnosed with asthma, you may enroll in the study if you are regularly followed by a pulmonologist who will verify, in writing, that your asthma symptoms are well-controlled (apart from cough symptoms) with your current medication protocol, which would not be altered when you are in the study. In order to remain in the study, your forced expiratory volume (FEV1), which will be measured during baseline lung function testing with spirometry, must be no less than 60% of predicted values given age, height, and weight. You must also carry a rescue inhaler with you when participating in all assessment and treatment sessions.
• • Willing to sign an informed consent form
• Exclusion Criteria:
• • Under 18 years of age
• • Positive for COVID-19 or presenting with any of the following symptoms of COVID- 19: fever or chills, sputum, difficulty breathing, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
• • Have not followed current local, state, and CDC COVID-19 mitigation guidance, especially regarding travel.
• • Unwilling to comply with COVID-19 precautions (see below)
• • Currently a smoker of any substance
• • Pregnant or attempting to become pregnant
• • Diagnosed with a respiratory or pulmonary condition (other than asthma) that commonly contributes to cough (e.g., chronic obstructive pulmonary disease, emphysema, lung cancer, bronchitis)
• • Diagnosed with asthma that is not well managed and/or do not have the necessary written consent by a pulmonologist to be in the study.
• • Suffering from any signs of upper respiratory illness
• * Taken any of the following medications within the past month:
• • lisinopril/Prinivil/Zestril
• • captopril/Capoten
• • enalapril/Epaned/Asotec, ramipril/Altace
• • benazepril/Lotensin
• • fosinopril/Monopril
• • moexipril/Univasc
• • perindopril/Aceon
• • quinapril/Accupril
• • trandolapril/Mavik