Table 1.
Study Inclusion and Exclusion Criteria
| Inclusion Criteria | Exclusion Criteria | |
|---|---|---|
| Subjects with allergic rhinitis and asthma | Age 18–55 yr | Current use of antihistamines, nasal steroids, LTRA, or tiotropium |
| Clinical diagnosis of asthma | Current symptoms of rhinitis | |
| Positive skin prick test to timothy grass pollen (in a panel of 10 aeroallergens) | Smoking history in the past 6 mo | |
| Histamine PC20 < 8 μg/ml (or <12 μg/ml and bronchodilator response ≥12%) | History of clinically relevant systemic disease or respiratory disease (other than asthma) | |
| Daily ICS (daily dose ≥400 μg fluticasone or equivalent) or ICS and LABA | OCS treatment in the previous 3 mo | |
| ACQ score > 0.75 | Pregnant or breastfeeding women | |
| Healthy subjects | Age 18–55 yr | Smoking history in the past 6 mo |
| PC20 > 8 μg/ml and bronchodilator response <12% | Positive skin prick test | |
| History or current symptoms of atopic disease such as allergic rhinitis, asthma, or eczema | ||
| Shortness of breath at screening | ||
| History of respiratory or significant systemic disease | ||
| Use of ICS or OCS in the previous 3 mo | ||
| Current use of LABA, nasal spray, antihistamine, LTRA, or tiotropium | ||
| Pregnant or breastfeeding women |
Definition of abbreviations: ACQ = Asthma Control Questionnaire, ICS = inhaled corticosteroid; LABA = long-acting β2 agonist; LTRA = leukotriene receptor antagonist; OCS = oral corticosteroid; PC20 = concentration of histamine required to reduce FEV1 by 20%.