Effects of Pine Cone Extract on Serum IgE Levels in Perennial Rhinitis (PCE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Perennial Allergic Rhinitis
• Intervention / Treatment: Other: placebo; Dietary supplement: pine cone extract

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33613
      • Usf Asthma Allergy and Immunology Cru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects with perennial allergic rhinitis with or without seasonal allergic rhinitis
2. Male or female participants must be 18 years of age or older

Exclusion Criteria:

1. Subjects receiving subcutaneous allergen immunotherapy or monoclonal anti-IgE (omalizumab)
2. Subject with hypersensitivity to PPC
3. Pregnant subjects (lactating post-partum women will be allowed to participate)
4. Subjects who are unable to cooperate/comply with study procedures or communicate with investigator in order to successfully complete the study
5. 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
6. Subjects with an infirmity, disability, or geographical location which seems likely to prevent regular attendance for patient visits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: capsule; patinets receiveing pine cone extract tablets	Dietary supplement: pine cone extract; pine cone extract capsule
Placebo Comparator: placebo capsule; patinets receiving placebo	Other: placebo; placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Dennis Ledford, M.D., Division of Allergy and Immunology, USF

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: June 7, 2012
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: perennial allergic rhinitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
• Other Study ID Numbers: Pine Cone Extract