Summary
The blocking effects of inhaled beclomethasone dipropionate (BDP) and fluocortin butyl ester (FCB) on the immediate and late asthmatic reactions induced by inhaled allergen were studied in two trials. In the first, a double‐blind cross‐over trial compared BDP (800 μg daily as powder) with FCB 8 mg daily (1:20 by wt.‐Formulation 1). The second trial was identical in design and compared FCB 8 mg daily (1:20) with FCB 8 mg daily as Formulation 2 (1:40). Known BDP, 400 μg daily by pressurized aerosol was studied at the end of the second trial.
Allergen provocation was performed before and after 7 days treatment with each drug, with a 2‐week interval between each drug.
Overall, a blocking index for the immediate reaction of greater than 50% was obtained in ten of twenty patients (50%) using BDP, and five of twenty‐one (25%) using FCB (P < 0‐01). The late reaction was blocked in nine of eleven (82%) instances on BDP, and four of fourteen (33%) on FCB.
Contrary to earlier reports, inhaled corticosteroid agents used for several days prior to bronchial challenge, were found to block both the immediate as well as the late‐reaction in many individuals.
Human recombinant DNA interferon gamma (IFN-G), with a specific activity of 2 X 10(6) IU/mg protein, was administered s.c. 3 days per week for 2 months to patients with solid tumors. The maximum tolerated dose (MTD) was 10 X 10(6) IU/m2 (5.0 mg/m2) per injection, and six patients were treated at the MTD. Two of these ceased treatment because of severe subjective toxicity (headache, rigors and pyrexia) and three patients developed WHO grade 3 leucopenia. Subjective toxicity varied considerably between patients and some patients at low dose levels experienced severe constitutional symptoms whilst others treated at the MTD had few side effects. These differences were unrelated to pharmacokinetic parameters. Bioavailability of this IFN-G administered s.c. was very variable from one patient to another at the same dose level. We therefore counsel caution in using this IFN-G preparation s.c. in phase II studies.
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