Validation of an Environmental Exposure Chamber for Inhalation Studies With House Dust Mite Allergen in Patients With Allergic Rhinitis

Inclusion Criteria:

• Male and female subjects aged 18-55 years.

• Non smokers or ex-smokers with a history of less than 10 pack years, having beennonsmokers for at least the last 12 months.

• History of allergic rhinitis to house dust mite. Subjects with mild intermittentasthma that is controlled with occasional use of as-needed short-acting beta-agonistsmay be included.

• Normal lung function (FEV1 ≥ 80 % pred)

• Positive skin prick test for dermatophagoides pteronyssinus.

• Able and willing to give written informed consent to take part in the study.

• Available to complete all study measurements.

• Women will be considered for inclusion if they are:

• Not pregnant, as confirmed by pregnancy test (see flow chart) and not nursing.

• Of non-child bearing potential (i.e. physiologically incapable of becomingpregnant, including any female who is pre-menarchial or post-menopausal, withdocumented proof of hysterectomy or tubal ligation, or meet clinical criteria formenopause and has been amenorrhoeic for more than 1 year prior to the screeningvisit).

• Of childbearing potential and using a highly effective method of contraceptionduring the entire study (vasectomised partner, sexual abstinence - the lifestyleof the female should be such that there is complete abstinence from intercoursefrom two weeks prior to the first dose of study medication until at least 72hours after treatment -, implants, injectables, combined oral contraceptives,hormonal IUDs or double-barrier methods, i.e. any double combination of IUD,condom with spermicidal gel, diaphragm, sponge, and cervical cap).

Exclusion Criteria:

• History of a respiratory tract infection and/or exacerbation of asthma within 4 weeksbefore the screening.

• Any history of life-threatening asthma, defined as an asthma episode that requiredintubation and/or was associated with hypercapnea, respiratory arrest or hypoxicseizures.

• Administration of oral, injectable or dermal corticosteroids within 8 weeks orintranasal and/or inhaled corticosteroids 4 weeks prior to enrollment.

• Past or present disease, which as judged by the investigator, may affect the outcomeof this study. These diseases include, but are not limited to, cardiovascular disease,malignancy, hepatic disease, renal disease, hematological disease, neurologicaldisease, endocrine disease or pulmonary disease (including but not confined to chronicbronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).

• Any structural nasal abnormalities or nasal polyps on examination, history of frequentnose bleeding or recent nasal surgery.

• Conditions or factors, which would make the subject unlikely to be able to stay in theFraunhofer ECC for four to six hours.

• Specific Immunotherapy (SIT) within the last two years prior to screening.

• Risk of non-compliance with study procedures.

• Participation in another clinical trial 30 days prior to enrolment.

• Any contraindication for adrenalin use (e.g. use of local and systemic beta-blockers)

• Intolerance to any excipients especially lactose and/or milk products

• History of drug or alcohol abuse