Perennial Allergic RhinitisPCENCT04024033
Effects of Pine Cone Extract on Serum IgE Levels in Perennial Rhinitis
A study testing pine cone extract in people with Perennial Allergic Rhinitis, run by University of South Florida at 1 site in United States.
Trial summary
The medicinal properties of pinecones have been used for years to treat a variety of illnesses. In the mouse model, an extract of pine cones, poly-phenylpropanoid-polysaccharide complex (PPC), has been shown to reduce total serum IgE levels as well as decreased production of IL-4, a cytokine associated with allergic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- pine cone extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with perennial allergic rhinitis with or without seasonal allergic rhinitis
- Male or female participants must be 18 years of age or older
Who cannot join
- Subjects receiving subcutaneous allergen immunotherapy or monoclonal anti-IgE (omalizumab)
- Subject with hypersensitivity to PPC
- Pregnant subjects (lactating post-partum women will be allowed to participate)
- Subjects who are unable to cooperate/comply with study procedures or communicate with investigator in order to successfully complete the study
- Subjects with severe skin disorders such as atopic dermatitis, dermatographism, psoriasis who could not have allergy skin testing and who have no prior skin testing completed within 3 years
- Subjects with an infirmity, disability, or geographical location which seems likely to prevent regular attendance for patient visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Usf Asthma Allergy and Immunology Cru
Tampa, Florida, 33613
About this study
The medicinal properties of pinecones have been used for years to treat a variety of illnesses. In the mouse model, an extract of pine cones, poly-phenylpropanoid-polysaccharide complex (PPC), has been shown to reduce total serum IgE levels as well as decreased production of IL-4, a cytokine associated with allergic disease. In this study, the investigators aim to determine the effects that PPC will have on total serum IgE levels in adult subjects with perennial rhinitis.
Read the detailed description
The study will be a parallel two-arm, double-blind design. The 80% power calculation was based upon preliminary data showing a greater than 30% reduction of total serum IgE in PPC recipients. This power calculation concluded that each arm will need a population of 18 subjects. These subjects will be recruited from a clinical practice of 4 academic allergists/immunologists. Seasonal allergy information will be recorded but the data will be analyzed for each group without any correction for seasonal effects.
Recruited subjects will sign the consent form, undergo a complete physical exam, and have skin testing repeated if historical skin tests data within three years is unavailable. The historical skin tests must have been performed using the same techniques as those used in the study. A prick skin test method using commercially available extracts will be used and the results graded according to standard criteria with measurements of the wheal and flare compared to the results of a positive control with histamine and a negative control of saline. A positive skin test will be defined as a wheal diameter 3 mm larger than the negative control with a flare of greater than or equal to 10 mm.
A nasal mucosal sample will also be obtained from the inferior turbinate with a plastic device (rhinoprobe). This sample will be frozen at the time of collection for future analysis. This procedure will be optional for subjects; if they consent it will be performed at each visit After screening, patients will be randomized to either of the two arms (placebo, or 32mg PPC/d). Patients will be instructed to take one capsule via oral route daily for 8 weeks. Subjects will be treated for two months with measurements of total serum IgE at the initial screening/randomization visit and following two months of treatment. Physical examination will be repeated at each visit. A variance of 5 days will be permitted for follow-up visits.
Rescue treatment with oral, non-sedating antihistamine will be permitted and number of doses will be recorded at each follow up visit. No nasal sprays will be allowed during the study. If symptoms are extreme, the study subject will be discontinued from the trial.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- pine cone extract, placebo
- Keywords
- perennial allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pine cone extractDietary supplement
pine cone extract capsule
placeboOther
placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| capsule | Active comparator | patinets receiveing pine cone extract tablets Receives: Dietary Supplement: pine cone extract |
| placebo capsule | Placebo comparator | patinets receiving placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective ( total serum IgE)
To provide the proof-of-concept that daily administration of Immune Extra ™(each capsule with 16 mg total pine cone extract or 6 mg of PPC) reduces total serum IgE in subjects with rhinitis and sensitivity to perennial allergens, including dust mite (Dermatophagoides pteronyssinus and Dermatophagoides farinae), cockroach, cat, and dog.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study startMar 2011
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergic RhinitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis Ledford, M.D., Principal investigator, Division of Allergy and Immunology, USF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024033
- Sponsor's protocol ID
- Pine Cone Extract
- Acronym
- PCE
- Status last verified
- Nov 2022
- First submitted
- 7 Jun 2012
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pine Cone Extract on Serum IgE Levels in Perennial Rhinitis
- ClinicalTrials.gov ID
- NCT04024033
- Acronym / sponsor ID
- PCE / Pine Cone Extract
- Conditions
- Perennial Allergic Rhinitis
- Keywords
- perennial allergic rhinitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 18 Jul 2019 (actual)
- 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.
The medicinal properties of pinecones have been used for years to treat a variety of illnesses. In the mouse model, an extract of pine cones, poly-phenylpropanoid-polysaccharide complex (PPC), has been shown to reduce total serum IgE levels as well as decreased production of IL-4, a cytokine associated with allergic disease. In this study, the investigators aim to determine the effects that PPC will have on total serum IgE levels in adult subjects with perennial rhinitis.
Detailed description
The study will be a parallel two-arm, double-blind design. The 80% power calculation was based upon preliminary data showing a greater than 30% reduction of total serum IgE in PPC recipients. This power calculation concluded that each arm will need a population of 18 subjects. These subjects will be recruited from a clinical practice of 4 academic allergists/immunologists. Seasonal allergy information will be recorded but the data will be analyzed for each group without any correction for seasonal effects.
Recruited subjects will sign the consent form, undergo a complete physical exam, and have skin testing repeated if historical skin tests data within three years is unavailable. The historical skin tests must have been performed using the same techniques as those used in the study. A prick skin test method using commercially available extracts will be used and the results graded according to standard criteria with measurements of the wheal and flare compared to the results of a positive control with histamine and a negative control of saline. A positive skin test will be defined as a wheal diameter 3 mm larger than the negative control with a flare of greater than or equal to 10 mm.
A nasal mucosal sample will also be obtained from the inferior turbinate with a plastic device (rhinoprobe). This sample will be frozen at the time of collection for future analysis. This procedure will be optional for subjects; if they consent it will be performed at each visit After screening, patients will be randomized to either of the two arms (placebo, or 32mg PPC/d). Patients will be instructed to take one capsule via oral route daily for 8 weeks. Subjects will be treated for two months with measurements of total serum IgE at the initial screening/randomization visit and following two months of treatment. Physical examination will be repeated at each visit. A variance of 5 days will be permitted for follow-up visits.
Rescue treatment with oral, non-sedating antihistamine will be permitted and number of doses will be recorded at each follow up visit. No nasal sprays will be allowed during the study. If symptoms are extreme, the study subject will be discontinued from the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| capsule | Active comparator | Dietary Supplement: pine cone extractpatinets receiveing pine cone extract tablets |
| placebo capsule | Placebo comparator | Other: placebopatinets receiving placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with perennial allergic rhinitis with or without seasonal allergic rhinitis
- Male or female participants must be 18 years of age or older
Key exclusion criteria (6 listed)
- Subjects receiving subcutaneous allergen immunotherapy or monoclonal anti-IgE (omalizumab)
- Subject with hypersensitivity to PPC
- Pregnant subjects (lactating post-partum women will be allowed to participate)
- Subjects who are unable to cooperate/comply with study procedures or communicate with investigator in order to successfully complete the study
- Subjects with severe skin disorders such as atopic dermatitis, dermatographism, psoriasis who could not have allergy skin testing and who have no prior skin testing completed within 3 years
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 |
|---|---|---|
| pine cone extractpine cone extract capsule | Dietary supplement | capsule |
| placeboplacebo capsule | Other | placebo capsule |
Primary outcome
Primary Objective ( total serum IgE)
Time frame: 8 weeks
To provide the proof-of-concept that daily administration of Immune Extra ™(each capsule with 16 mg total pine cone extract or 6 mg of PPC) reduces total serum IgE in subjects with rhinitis and sensitivity to perennial allergens, including dust mite (Dermatophagoides pteronyssinus and Dermatophagoides farinae), cockroach, cat, and dog.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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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.
Dennis Ledford, M.D. principal investigator
Division of Allergy and Immunology, USF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pine cone extract in people with Perennial Allergic Rhinitis, 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 May 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Primary Objective ( total serum IgE) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2023.