Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BB100A and BB100B
Study information
Scientific title
Acronym
BB100A and BB100B
Study hypothesis
1. To evaluate the ability of ALAP-1 compared with placebo to reduce the signs and symptoms of allergic rhinitis (AR) in the presence of a nasal histamine challenge
2. To evaluate the efficacy of chronic dosing of ALAP-1 compared with placebo on reducing the symptoms of AR induced by nasal histamine challenge
Ethics approval
Approval received from the Copernicus Group Institutional Review Board (IRB) on the 19th September 2006 (ref: MED4-06-238).
Study design
Randomised double-blind placebo controlled crossover study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Seasonal allergic rhinitis
Intervention
ALAP-1 (herbal combination) versus placebo. ALAP-1 is an herbal combination formulated to prevent and reduce AR symptoms. This proprietary formula is a standardised blend of the following eleven botanical extracts: Cullen corylifolium (Psoralea fruit), Xanthium sibiricum (Xanthium fruit), Scutellaria baicalensis (Chinese skullcap root), Gardenia augusta (Gardenia fruit), Bupleurum chinense (Bupleurum root), Chrysanthemum x moriflolium (Chrysanthemum flower), Areca catechu (Areca husk), Schisandra spp. (Schisandra fruit), Ziziphus jujuba var. spinosa (Jujube seed), Nepeta tenuifolia (Schizonepeta aerial parts) and Plantago asiatica (Asian plantain seed).
Three-day study:
Subjects will consume three capsules of ALAP-1 (1350 mg) or placebo per day for two days and return to the research office on the third day for evaluation. Subjects undergo their baseline peak nasal inspiratory flow (PNIF) measurement and then consume four capsules of ALAP-1 (1800 mg) or placebo. Fifteen minutes later, the nasal histamine provocation is performed. Shortly after the histamine challenge, subjects consume an additional 4 capsules of ALAP-1 (1800 mg) or placebo. This dosing regimen simulates the method in which the formula would be used in practice: daily preventive doses during allergy season and a treatment dose in the event of direct exposure to an environmental allergen. Subjects then wash out for 1 week and are then enrolled into the opposite arm (active or placebo).
One month study:
Subjects will receive ALAP-1 or placebo for 4 weeks total. Initally, ALAP-1 (or placebo) is provided for 2 weeks at a high dose (1350 mg/day) and subjects undergo nasal histamine provocation and peak nasal inspiratory flow (PNIF) measurements. Then subjects are given ALAP-1 or placebo for 2 weeks at a low dose (900 mg/day). Subjects washout for 1 week and then are enrolled in the opposite arm.
Intervention type
Drug
Phase
Not Specified
Drug names
ALAP-1
Primary outcome measures
Peak nasal inspiratory flow meter, measured at 0, 10, 20, 30, 45 and 60 minutes post-histamine challenge on the study visit days.
Secondary outcome measures
Sneeze score, measured at 0, 10, 20, 30, 45 and 60 minutes post-histamine challenge on the study visit days.
Overall trial start date
01/09/2006
Overall trial end date
01/04/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 18 - 59 years, either sex
2. A history of seasonal allergic rhinitis
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Atrophic rhinitis
2. Rhinitis medicamentosa
3. Nasal polyps
4. Septal deviation
5. Active bacterial or viral sinusitis
6. Severe asthma
7. Peptic ulcer disease or active gastroesophageal reflux disease (GERD)
8. History of anaphylaxis to any allergen
9. Pregnancy
10. Active bacterial or viral rhinitis
11. Nasal surgery within the last eight weeks
Recruitment start date
01/09/2006
Recruitment end date
01/04/2007
Locations
Countries of recruitment
United States of America
Trial participating centre
18250 Roscoe Blvd.
Northridge
91325
United States of America
Sponsor information
Organisation
Radix Bioscience (USA)
Sponsor details
4436 Reeves Road
Ojai
93023
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Radix Bioscience (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary