Wiebicke 1990.
| Methods | Setting: Germany, hospital outpatient clinic Length of intervention period: 3 weeks Randomisation: yes, method not stated Allocation concealment: unclear Design: parallel group Masking: double blind Excluded: not stated Withdrawals: stated (none) Baseline characteristics: comparable Jadad score: 3 | |
| Participants | 25 adults: 14M 11F Age range: 18 to 41 years Inclusion criteria: Mild asthma (not further defined) not requiring regular medication FEV1 > 75 (% predicted) Non smokers Methacholine and histamine BHR (PC100 Sraw < 8.0mg/ml). Exclusion criteria: Respiratory tract infection in last 6 weeks | |
| Interventions | BDP: 250 mcg 2 pfs 4x daily (2000 mcg/d) Placebo: 2 pfs 4xdaily Delivery device: MDI+spacer |
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| Outcomes | Histamine BHR (PC100SRaw) Methacholine BHR (PC100SRaw) Bronchial responsiveness to isocapnic hyperventilation (PV75SRaw) Bronchial responsiveness to isocapnic SO2 hyperventilation (PV75Sraw) Specific airway resistance | |
| Notes | No reply from author to clarify details of method of randomisation. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |
ATS: American Thoracic Society; BDP: beclomethasone dipropionate; BHR: bronchial hyper‐responsiveness; BUD: budesonide; DLCO: carbon monoxide diffusing capacity; DPI: dry powder inhaler; ECP: eosinophil cationic protein; FEV1: forced expired volume in one second; FEF25‐75: forced expiratory flow at 25 to 75% of FVC; FEF25: maximal expiratory flow at 25% of FVC; FEF50: maximal expiratory flow at 50% of FVC; FEF 75: maximal expiratory flow at 75% of FVC; FVC: forced vital capacity; GINA: Global Initiative for Asthma; GM‐CSF: granulocyte‐macrophage colony stimulating factor; ICS: inhaled corticosteroid; IGF‐1: insulin‐like growth factor; MDI: metered dose inhaler; MMFR: maximum mid‐expiratory flow rate; OCS: oral corticosteroid; PC100 SRaw: concentration of inhalant necessary to increase SRaw by 100%; PC20 FEV1: concentration of inhalant required to produce a 20% fall in FEV1; PD100 Raw: dose of inhalant necessary to increase Raw by 100%; PD20 FEV1: dose of inhalant required to produce a 20% fall in FEV1; PDGF: platelet derived growth factor; PEFR: peak expiratory flow rate; PV75 SRaw: provocative ventilation necessary to increase SRaw by 75%; Raw: airway resistance RV: residual volume; SRaw: specific airway resistance; SO2: sulphur dioxide; TDI: toluene diisocyanate; TGF‐1beta: transforming growth factor one beta; TLC: total lung capacity; VC: vital capacity