Efficacy of Broncho-Vaxom® in allergic rhinitis

ISRCTN	ISRCTN37877803
DOI	https://doi.org/10.1186/ISRCTN37877803
Protocol serial number	BV-2007/03
Sponsor	OM Pharma SA (Switzerland)
Funder	OM Pharma SA

Submission date: 29/05/2012
Registration date: 12/06/2012
Last edited: 02/08/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr François Spertini
Scientific

Division of Allergy and Immunology Centre Hospitalier Universitaire Vaudois Rue du Bugnon
Lausanne
1011
Switzerland

Study information

Primary study design	Interventional
Study design	Monocentric randomised placebo-controlled double-blind parallel group comparison phase IIa study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Efficacy of Broncho-Vaxom® in allergic rhinitis: A randomized, double-blind, placebo-controlled phase IIa study
Study objectives	Efficacy of Broncho-Vaxom® in preventing symptoms of allergic rhinitis as induced by a nasal provocation test with grass-pollen.
Ethics approval(s)	Ethics Committee of Clinical Research (Commission d'Ethique de la Recherche clinique), 07.05.2007, ref: 126/07
Health condition(s) or problem(s) studied	Seasonal allergic rhinitis
Intervention	Subjects were randomly assigned in an equal ratio to one of the two treatment arms. A stratified randomization was performed according to the outcome of the NPT screening (1st stratumthreshold level ≤ 1000 SQ/ml: high sensitive subjects, 2nd stratum-threshold level >1000 SQ/ml: low sensitive subjects). The dosage regimen was one capsule per day of Broncho-Vaxom® (1 capsule of 7 mg in the morning on an empty stomach) or placebo starting at least 7 days after the nasal provocation test (NPT) screening. The study period was a 30-days treatment period with a second NPT occurring one day before the end of treatment and a final visit with collection of nasal samples on the last day.
Intervention type	Other
Primary outcome measure(s)	1. The primary efficacy endpoint was defined as a difference in combined clinical thresholds to allergen nasal provocation test of at least one allergen dose level. The nasal reaction threshold (combined threshold) was reached when at least 2 of the 3 following clinical criteria were fulfilled: 1.1. Five or more sneezes in the first 10 minutes after the challenge, an increase from baseline value (obtained after diluent challenge) of at least 0.5 g of nasal secretions 10 minutes after the challenge, and a decrease from baseline values ≥40% in PNIF and/or ≥ 30% in MCA 10 minutes after the challenge. at baseline (V1), treatment start(V2) , 29 days (V3) and 30 days (V4)
Key secondary outcome measure(s)	1. Objective symptom ratings 2. Subjective symptom ratings by means of a visual analogue scale (VAS) 3. Early and late allergic phase markers (from nasal secretions) at baseline (V1), treatment start(V2) , 29 days (V3) and 30 days (V4)
Completion date	29/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Subjects must be 18 to 40 years of age, of either sex and any ethnic origin 2. Subjects must have at least a 2 year history of grass pollen induced seasonal allergic rhinitis (documented or reported by the patient) 3. Subjects must have a positive skin prick test response (wheel diameter >3 mm) and/or specific IgE for grass pollen (>0.35 kU/L). 4. Subjects must have a nasal reaction threshold of 10, 000 or less standardized quality units (SQs)/mL grass pollen, performed at the inclusion visit 5. Subjects must be free of any clinically significant disease, other than seasonal allergic rhinitis, which could 6. 6. 6. Subjects must have given written informed consent and must be able to adhere to dose, visits schedule and meet study requirements 7. In females of childbearing potential, the urine pregnancy test must be negative before performing the screening 8. Non-sterile or premenopausal female subjects must be using a medically accepted method of birth control, that is, oral contraceptive, hormonal implant, medically prescribed IUD, or depot injectable during the entire study. A female subject who was not of childbearing potential must have a medical record of being surgically sterile (for example, hysterectomy, and tubal ligation), or be at least 1 year postmenopausal
Key exclusion criteria	1. Subjects who have had an episode of allergic rhinitis in the last two weeks prior to screening 2. Subjects who have had an upper respiratory tract or sinus infection, that required antibiotherapy, or who have had a viral upper respiratory infection, in the last two weeks prior to screening 3. Subjects with asthma who require chronic use of inhaled or systemic corticosteroids (decrease of peak flow > 20% of usual subject value) 4. Subjects with current seasonal (SAR) or perennial (PAR) allergic rhinitis 5. Subjects with known clinical allergic symptoms compatible with sensitization to tree pollens 6. Subjects with clinically significant nasal structural abnormalities (e.g. marked nasal septum deviation, major poliposis) that significantly interfere with nasal air flow 7. Subjects with current evidence of clinically significant haematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other disease that preclude the subject's participation in the study 8. Subjects with a current history of frequent, clinically significant sinusitis or chronic purulent postnasal drip, or necessitating chronic intake of antibiotherapy 9. Subjects with non-specific nasal reaction (e.g. threshold reached with diluents alone at inclusion) 10. Subjects smoking more than 10 cigarettes/day and/or known to have severe alcohol intake and/or drug addiction 11. Subjects with intolerable symptoms that would make participating in the study unbearable 12. Subjects with a history of anaphylaxis and/or severe local reactions(s) to skin testing with allergens 13. Subjects with a history of hypersensitivity to the study drug 14. Subjects on immunotherapy or desensitization therapy 15. Subjects receiving any medication that might affect the test parameters (oral or topical antihistamines, steroids, antidepressants with antiallergical properties) within 2 weeks before study start (1 month for corticosteroids)
Date of first enrolment	08/08/2007
Date of final enrolment	29/01/2008

Locations

Countries of recruitment

Switzerland

Study participating centre

Division of Allergy and Immunology Centre Hospitalier Universitaire Vaudois Rue du Bugnon

Lausanne
1011
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes