| Methods |
DESIGN: double‐blind, parallel, placebo‐
controlled study
METHOD OF RANDOMISATION: not specified
CONCEALMENT OF RANDOMISATION: not specified
PATIENT BLINDING: said to be double‐blind
PROVIDER BLINDING: said to be double‐blind
OUTCOME ASSESSOR BLINDING: not specified
WITHDRAWALS: 0
DROP‐OUTS: 1 (from the treatment group because of viral meningitis) |
| Participants |
ELIGIBLE: 23
ENROLLED: 20
COMPLETED: 19
AGE (MEAN): 35
SEX (male/female): not specified
NUMBER IN THE TREATMENT GROUP: 9
NUMBER IN THE CONTROL GROUP: 11
RECRUITMENT:
local GP and the Allergy and Chest Clinic of the Churchill Hospital in Oxford, UK
ASTHMA DIAGNOSIS: questionnaire (clinical criteria)
ASTHMA SEVERITY: not homogeneous (some with asthma = FEV1 < 76% and some without asthma FEV1 > 85%)
RHINITIS DIAGNOSIS: clinical criteria
RHINITIS CLASSIFICATION: seasonal allergic rhinitis
ATOPY MARKERS: SPT > 3 mm for grass mix and negative for house dust mites, specific IgE for grass pollen mix, tree pollen mix and rape pollen)
INCLUSION: unselected hay fever sufferers, half with a history of previous seasonal wheezing
EXCLUSION: not specified |
| Interventions |
SETTING: not specified
TREATMENT GROUP: intranasal beclomethasone 50 ug 2 puffs in each nostril 2/d
(concomitant treatment: cetrizine 10 mg prn, inhaled salbutamol 0.1 ug prn, topical eye drops prn)
PLACEBO GROUP: intranasal placebo 2 puffs each nostril 2/d (concomitant treatment: cetirizine 10 mg prn, inhaled salbutamol 0.1 ug prn, topical eye drops prn)
DURATION: 3 months |
| Outcomes |
‐asthma score (cough, wheeze and number of puffs of salbutamol) from julian days D160‐175
‐wheeze score from D160‐175
‐cough score from D160‐175
‐log PD20 methacholine (umol) from D160‐175
‐number of puffs of Ventolin from D160‐175
‐morning PEF (l/m) from D160‐175
‐evening PEF (l/m) from D160‐175 |
| Notes |
Jadad score 3 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available |
