| 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:
not described in detail but double‐blind stated
WITHDRAWALS/ DROP‐OUTS: not stated |
| Participants |
ELIGIBLE: not stated
ENROLLED: 50
COMPLETED: 50
AGE (MEAN): 27.8
SEX (male/female): stated but with an error (33/21)
NUMBER IN THE TREATMENT GROUP: 24
NUMBER IN THE CONTROL GROUP: 26
RECRUITMENT: 2 outpatient clinics from northern Italy
ASTHMA DIAGNOSIS: no asthma
ASTHMA SEVERITY: 0
RHINITIS DIAGNOSIS: clinical criteria
RHINITIS CLASSIFICATION: allergic seasonal rhinitis
ATOPY MARKERS: SPT for a mixture of grasses or parieteria
INCLUSION: history of seasonal allergic rhinitis of at least 3 years, no asthma, no previous specific immunotherapy
EXCLUSION: nasal polyps and sinusitis, esthablished asthma or wheeze, antihistamines in the previous 6 weeks, nasal surgery in the previous 6 months |
| Interventions |
SETTING: Not certain but in northen Italy
TREATMENT GROUP: intranasal fluticasone 50 ug/ in 2 puffs in each nostril once a day = 200 ug/d
CONTROL GROUP: intranasal placebo 2 puffs in each nostril 1 day (rescue medication for both groups: salbutamol spray, terfenadine 60 mg, Na cromoglycate eye drops (dose not specified)
DURATION: 6 weeks |
| Outcomes |
‐chest symptoms at the end of trial (visit 4)
‐FEV1 (L) at the end of the trial at week 6
‐PC20 methacholine (mg) at the end of the trial |
| Notes |
Jadad score 3 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available |
