| Methods |
DESIGN: double‐blind, randomised, comparative, parallel study
METHOD OF RANDOMISATION: not specified
CONCEALMENT OF RANDOMISATION: not specified
PATIENT, PROVIDER AND OUTCOME ASSESSOR BLINDING: stated double‐blinded
WITHDRAWALS/DROP‐OUTS: 0 |
| Participants |
ELIGIBLE: not specified
ENROLLED: 41
COMPLETED: 41
AGE (MEAN): 29
SEX (male/female): 22/19
NUMBER IN THE TREATMENT GROUP: 20
NUMBER IN THE CONTROL GROUP: 21
RECRUITMENT: Ear, nose and throat department, Uppsala, Sweden
ASTHMA DIAGNOSIS: history, need for B2 agonists, PC20 methacholine < 8 mg/ ml outside the pollen season
ASTHMA SEVERITY: not sated: but 20 had no asthma and 21 had asthma
RHINITIS DIAGNOSIS:
history
RHINITIS CLASSIFICATION: seasonal allergic rhinoconjonctivitis
ATOPY MARKERS: SPT and IgE for birch
INCLUSION: birch pollen allergic patients with some having only rhinoconjonctivitis and other having rhinoconjonctivitis and asthma.
EXCLUSION: perennial rhinitis symptoms, SPT to house dust mites or moulds |
| Interventions |
SETTING: Ear, nose and throat department, Uppsala, Sweden
TREATMENT GROUP: intranasal budesonide 200 per nostril daily = 400 ug ug/d + specific immunotherapy to placebo
(concomitant drugs: local antihistamine, decongestant drops, antihistamine tablets)
PLACEBO GROUP: intranasal placebo 2 puffs every nostril daily + specific immunotherapy to birch
(concomitant drugs: local antihistamine, decongestant drops, antihistamine tablets)
DURATION: 6 weeks |
| Outcomes |
‐mean weekly PEF (% pred) at week 6
‐B2 agonist use (number of puffs) at week 6 ‐methacholine challenge (mg/ml) at week 6 |
| Notes |
Jadad score 3 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available |
