COPDPhase 1CapsaicinNCT01621685
Human Safety of Capsaicin Inhalation Challenge Testing for Young and Older Men
A Phase 1 study testing biological/vaccine in people with COPD, run by University of South Florida at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 19 to 92 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- biological/vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Sep 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 92 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%
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- 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
Who cannot join
- 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%);
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- "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. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Age on the Human Cough Reflex
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.
Read the detailed description
After a research subject's death during an inhalation study using medications/drugs not approved for this route, the FDA prohibited human use of non-approved chemicals including capsaicin administered via inhalation.
Capsaicin inhalation challenge tests (CICT) were performed on forty men of different ages utilizing pharmaceutical grade Capsaicin. Solutions were mixed by a registered pharmacist and Capsaicin doses, administered to subjects, were analyzed by high performance liquid chromatography (HPLC). Capsaicin solutions were stored in a refrigerator at 4 degrees C and shielded from ultraviolet light for 7 months. There was serial monitoring by spirometry and impulse oscillometry, electrocardiography, blood pressure, pulse and oxygen saturation measurements.
There were no adverse reactions at any dose, including the highest capsaicin concentration. Serial spirometry and impulse oscillometry, electrocardiography, blood pressure, pulse and oxygen saturation measurements did not change. The actual amount of pharmaceutical-grade capsaicin measured was 85.5% of the concentrations estimated by the registered pharmacist at time of mixing. The difference was more for the lowest 0.49 uMol dose (28.1) compared to a 2.2% lesser concentration for the 1000 uMol solution. Capsaicin concentrations fell after 3 months of storage.
Dilute capsaicin aerosol inhalation is relatively innocuous and CICT is safe. The actual amount of pharmaceutical-grade capsaicin inhaled by subjects is less than the estimate at mixing. Capsaicin loses potency after 3-months of protected storage. Inhalation studies involving non-approved drugs or chemicals/medications can be safely conducted when they follow the appropriate safety procedures such as described in this investigation.
- Conditions
- COPD
- Being tested
- biological/vaccine
- Keywords
- Capsaicin, Cough, Cough reflex, Inhalation agents, Inhalation challenge, TRPV1 receptor
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological/vaccineBiological
Also called >12% fall in FEV1, wheezing on chest auscultation or >4 on Symptom Questionnaire
Inhalation studies will immediately be terminated after a significant adverse response to a particular capsaicin dose and no further testing will occur.
| Study group | Role | What they receive |
|---|---|---|
| Spirometry, auscultation, questionnaire | Experimental | >12% fall in FEV1, wheezing on auscultation, symptom questionnaire score >4 Receives: Biological: biological/vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
>12% Fall In FEV1
Single breaths of capsaicin were delivered in ascending order, with normal saline solution randomly interspersed to increase challenge blindness, until two (C2) and five (C5) or more coughs were reached. The different concentrations were delivered at 2 minute intervals. After each inhalation dose the following were performed: FEV1 measurement, administer of the symptom questionnaire and auscultation of the chest for wheezing.
Measured: Baseline and >5 coughs 2-minutes after each inhaled capsaicin dose
Secondary outcomes (1)
Symptom Questionnaire
Over a 1-week period, repeated telephone calls recorded responses to 6 questions. Subjects were asked post-inhalation symptoms of: (1) heavy or difficulty in breathing; (2) phlegm production: (3) runny or irritated nose; (4) throat irritation or burning: (5) feeling of a weight or tightness of the chest; and, (6) feeling of chest burning. Any subject reporting continued symptoms of category #4 (i.e., very severe) for two or more items, compared to the baseline was asked to return for more detailed evaluation.
Measured: Repeatedly over 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startSep 2004
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Stuart M Brooks, University of South Florida
- Investigators
- Stuart M. Brooks, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621685
- Sponsor's protocol ID
- IND# 69,642
- Acronym
- Capsaicin
- Status last verified
- Jun 2012
- First submitted
- 5 Aug 2010
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kopec SE, DeBellis RJ, Irwin RS. Chemical analysis of freshly prepared and stored capsaicin solutions: implications for tussigenic challenges. Pulm Pharmacol Ther. 2002;15(6):529-34. doi: 10.1006/pupt.2002.0394.
PubMed 12493340
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Age on the Human Cough Reflex
- ClinicalTrials.gov ID
- NCT01621685
- Acronym / sponsor ID
- Capsaicin / IND# 69,642
- Conditions
- COPD
- Keywords
- Capsaicin, Cough, Cough reflex, Inhalation agents, Inhalation challenge, TRPV1 receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Sep 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After a research subject's death during an inhalation study using medications/drugs not approved for this route, the FDA prohibited human use of non-approved chemicals including capsaicin administered via inhalation.
Capsaicin inhalation challenge tests (CICT) were performed on forty men of different ages utilizing pharmaceutical grade Capsaicin. Solutions were mixed by a registered pharmacist and Capsaicin doses, administered to subjects, were analyzed by high performance liquid chromatography (HPLC). Capsaicin solutions were stored in a refrigerator at 4 degrees C and shielded from ultraviolet light for 7 months. There was serial monitoring by spirometry and impulse oscillometry, electrocardiography, blood pressure, pulse and oxygen saturation measurements.
There were no adverse reactions at any dose, including the highest capsaicin concentration. Serial spirometry and impulse oscillometry, electrocardiography, blood pressure, pulse and oxygen saturation measurements did not change. The actual amount of pharmaceutical-grade capsaicin measured was 85.5% of the concentrations estimated by the registered pharmacist at time of mixing. The difference was more for the lowest 0.49 uMol dose (28.1) compared to a 2.2% lesser concentration for the 1000 uMol solution. Capsaicin concentrations fell after 3 months of storage.
Dilute capsaicin aerosol inhalation is relatively innocuous and CICT is safe. The actual amount of pharmaceutical-grade capsaicin inhaled by subjects is less than the estimate at mixing. Capsaicin loses potency after 3-months of protected storage. Inhalation studies involving non-approved drugs or chemicals/medications can be safely conducted when they follow the appropriate safety procedures such as described in this investigation.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spirometry, auscultation, questionnaire | Experimental | Biological: biological/vaccine>12% fall in FEV1, wheezing on auscultation, symptom questionnaire score >4 |
Who may qualify
- Ages
- 19 to 92 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological/vaccineAlso: >12% fall in FEV1, wheezing on chest auscultation or >4 on Symptom QuestionnaireInhalation studies will immediately be terminated after a significant adverse response to a particular capsaicin dose and no further testing will occur. | Biological | Spirometry, auscultation, questionnaire |
Primary outcome
>12% Fall In FEV1
Time frame: Baseline and >5 coughs 2-minutes after each inhaled capsaicin dose
Single breaths of capsaicin were delivered in ascending order, with normal saline solution randomly interspersed to increase challenge blindness, until two (C2) and five (C5) or more coughs were reached. The different concentrations were delivered at 2 minute intervals. After each inhalation dose the following were performed: FEV1 measurement, administer of the symptom questionnaire and auscultation of the chest for wheezing.
1 secondary outcome
Symptom Questionnaire
Time frame: Repeatedly over 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2012.
- Results publication: PubMed 12493340Kopec SE, DeBellis RJ, Irwin RS. Chemical analysis of freshly prepared and stored capsaicin solutions: implications for tussigenic challenges. Pulm Pharmacol Ther. 2002;15(6):529-34. doi: 10.1006/pupt.2002.0394.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart M. Brooks, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing biological/vaccine in people with COPD, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
>12% Fall In FEV1 (time frame: Baseline and >5 coughs 2-minutes after each inhaled capsaicin dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01621685, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2012.