Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr François Spertini


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Efficacy of Broncho-Vaxom® in allergic rhinitis: A randomized, double-blind, placebo-controlled phase IIa study


Study hypothesis

Efficacy of Broncho-Vaxom® in preventing symptoms of allergic rhinitis as induced by a nasal provocation test with grass-pollen.

Ethics approval

Ethics Committee of Clinical Research (Commission d'Ethique de la Recherche clinique), 07.05.2007, ref: 126/07

Study design

Monocentric randomised placebo-controlled double-blind parallel group comparison phase IIa study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Seasonal allergic rhinitis


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 stratum–threshold 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



Phase II

Drug names

Primary outcome measure

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)

Secondary outcome measures

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)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants


Participant 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)

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

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

Sponsor information


OM Pharma SA (Switzerland)

Sponsor details

Rue du Bois du Lan 22

Sponsor type




Funder type


Funder name

OM Pharma SA

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes