Human Safety of Capsaicin Inhalation Challenge Testing for Young and Older Men

Completed · Phase 1

Conditions studied: COPD

In brief

In 2004, the investigators initiated a human Capsaicin inhalation experiment under an Investigational New Drug (IND) protocol approved by the FDA (IND 69,642) and the subject safety procedures instituted and approved by the Institutional Review Board (IRB). As part of the study protocol, inhaled Capsaicin solutions were analyzed using high performance liquid chromatography (HPLC). The investigation employed safety procedures while conducting the human inhalation investigations. In addition, during our investigations we observed discrepancies between the predicted Capsaicin concentrations mixed by a registered pharmacist and the actual capsaicin concentrations determined by HPLC. The stability of Capsaicin solutions stored over a seven month period and refrigerated at 4degrees C and protected against ultraviolet light were examined.

Key facts

Study ID

NCT01621685

Run by

University of South Florida

People needed

40

Starts

2004-09-01

Expected to finish

2007-09-01

Last updated by the study team

2012-06-18

Who can join

Age: 19 and older, up to 92. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Men of ages 18 and 30 (Dates of birth 1973-1985) or 55-92 years old (Dates of birth 1911-1948).
• Must not currently be a cigarette smoker. If an ex-smoker then has not smoked for at least 10 years and consumption were no more than 10 pack years.
• Agrees to volunteers for the study and willing to sign the informed consent form.
• There were negative/normal screening tests for the following
• Responses to the questionnaire deny current and prior respiratory diseases (including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung d9sase) and no current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis). Subjects must not be taking any cardiac medications or admit to a physician-diagnosed cardiac condition.
• "Normal" spirometry measurements with FEV1 \& FVC greater than 75% predicted and FEV1/FVC more than 69%
• Impedance oscillometry were within normal limits
• "Negative" physical examination of the chest with absence of wheezing and crackles on auscultation of the chest.
• Exhaled nitric oxide concentration is less than 35 ppb for younger and less than 65 ppb for older groups

You may not qualify if…

• men of: ages < 18, 31-54 and >92 years old;
• current cigarette smokers or exsmokers who have smoked within the past 10 years and/or smoked more than 10 pack/years;
• refusal to volunteer for the study and not willing to sign the informed consent form;
• screening test not considered "normal" by physician/PI and showing one or more of the following:
• one or more positive response to the questionnaire(e.g., current or past respiratory diseases including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung disease; and/or; current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis) and/or; admitting to taking a cardiac medication and/or; or physician-diagnosed cardiac condition (e.g., coronary heart disease, angina, myocardial infarction, valvular heart disease, cardiomyopathy, etc.);
• Abnormal spirometry measurements (FEV1 \&/or FVC <75% predicted and FEV1/FVC <69%);
• "Positive" physical examination (performed by Physician/PI) with presence of wheezing and/or crackles on auscultation of the chest;
• Impulse oscillometry >4 times normal limits;
• Exhaled nitric oxide of >35ppb for younger group and >65 ppb for older group. -

Where it is running

• College of Public Health — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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