| Methods |
DESIGN: randomised, double‐blind, placebo‐
controlled, parallel study
METHOD OF RANDOMISATION: not stated
CONCEALMENT OF RANDOMISATION: not stated
PATIENT, PROVIDER AND OUTCOME ASSESSOR BLINDING: just stated
WITHDRAWALS/DROP‐OUTS: 5 withdrawals from the intranasal azelastine treatment group: 2 for personal reasons, 1 for asthma, 2 for pregnancy . Two others withdrew from the intranasal beclomethasone group for unrelated disease and for asthma. Two withdrew from the placebo group for uncontrolled rhinitis and asthma. |
| Participants |
ELIGIBLE: not specified
ENROLLED: 45
COMPLETED: 36
AGE (MEAN): 25.6
SEX (male/female) for those completing the study: 21/15
NUMBER IN THE AZELASTINE
TREATMENT GROUP: 10
NUMBER IN THE BECLOMETHASONE
TREATMENT GROUP: 13
NUMBER IN THE CONTROL GROUP: 13
RECRUITMENT: Servizio of respiratory physiologia, Opedale di Sesto San Giovanni, Italy
ASTHMA DIAGNOSIS: no asthma
ASTHMA SEVERITY: 0
RHINITIS DIAGNOSIS: clinical seasonal symptoms for 3 consecutive years
RHINITIS CLASSIFICATION: seasonal allergic rhinitis
ATOPY MARKERS: SPT only to grasses
INCLUSION: history of allergic rhinoconjonctivitis for at least 3 consecutive years, SPT to grasses, no asthma
EXCLUSION: positive SPT to other aeroallergens than grasses, previous specific immunotherapy, asthma, deviated nasal septum, polyps |
| Interventions |
SETTING: Servizio of respiratory physiologia, Opedale di Sesto San Giovanni, Italy
TREATMENT GROUP A: intranasal beclomethasone 50 ug 2 puffs per nostril bd = 200 ug/d
TREATMENT GROUP B: Intranasal azelastine 0.14 ug 1 puff in each nostril bd
CONTROL GROUP: intranasal placebo 1 day
DURATION: 6 weeks |
| Outcomes |
‐FEV1 (% pred) during the pollen season (week
4) when comparing beclomethasone and placebo
‐FEV1 (% pred) during week 4 when comparing beclomethasone and azelastine
‐PD20 methacholine (umol) at week 4 when comparing beclomethasone to placebo
‐PD20 methacholine (umol) at week 4 when comparing beclomethasone to azelastine.
‐Chest symptoms at week 4 when comparing beclomethasone to placebo
‐Chest symptoms at week 4 when comparing beclomethasone to azelastine
‐medication requirement at week 4 when comparing beclomethasone to placebo ‐medication requirement at week 4 when comparing beclomethasone to azelastine |
| Notes |
Jadad score 3 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available |
