BACKGROUND Hereditary angioedema is characterized by recurrent attacks of angioedema of the skin, larynx, and gastrointestinal tract. Bradykinin is the key mediator of symptoms. Icatibant is a selective bradykinin B2 receptor antagonist. METHODS In two double-blind, randomized, multicenter trials, we evaluated the effect of icatibant in patients with hereditary angioedema presenting with cutaneous or abdominal attacks. In the For Angioedema Subcutaneous Treatment (FAST) 1 trial, patients received either icatibant or placebo; in FAST-2, patients received either icatibant or oral tranexamic acid, at a dose of 3 g daily for 2 days. Icatibant was given once, subcutaneously, at a dose of 30 mg. The primary end point was the median time to clinically significant relief of symptoms. RESULTS A total of 56 and 74 patients underwent randomization in the FAST-1 and FAST-2 trials, respectively. The primary end point was reached in 2.5 hours with icatibant versus 4.6 hours with placebo in the FAST-1 trial (P = 0.14) and in 2.0 hours with icatibant versus 12.0 hours with tranexamic acid in the FAST-2 trial (P<0.001). In the FAST-1 study, 3 recipients of icatibant and 13 recipients of placebo needed treatment with rescue medication. The median time to first improvement of symptoms, as assessed by patients and by investigators, was significantly shorter with icatibant in both trials. No icatibant-related serious adverse events were reported. CONCLUSIONS In patients with hereditary angioedema having acute attacks, we found a significant benefit of icatibant as compared with tranexamic acid in one trial and a nonsignificant benefit of icatibant as compared with placebo in the other trial with regard to the primary end point. The early use of rescue medication may have obscured the benefit of icatibant in the placebo trial. (Funded by Jerini; ClinicalTrials.gov numbers, NCT00097695 and NCT00500656.)

Persistent, itching nodules have been reported to appear at the injection site after allergen-specific immuno-therapy with aluminium-precipitated antigen extract, occasionally in conjunction with contact allergy to aluminium. This study aimed to quantify the development of contact allergy to aluminium during allergen-specific immunotherapy. A randomized, controlled, single-blind multicentre study of children and adults entering allergen-specific immunotherapy was performed using questionnaires and patch-testing. A total of 205 individuals completed the study. In the 3 study groups all subjects tested negative to aluminium before allergen-specific immunotherapy and 4 tested positive after therapy. In the control group 4 participants tested positive to aluminium. Six out of 8 who tested positive also had atopic dermatitis. Positive test results were found in 5/78 children and 3/127 adults. Allergen-specific immunotherapy was not shown to be a risk factor for contact allergy to aluminium. Among those who did develop aluminium allergy, children and those with atopic dermatitis were more highly represented.

Two studies are presented, with the aim of establishing the dose potency ratio for salbutamol given via Turbuhaler® and via a pressurized metereddose inhaler (pMDI). Both studies were of a double-blind, randomized design. Outpatients with mild-to-moderate chronic reversible airway obstruction were given single doses of salbutamol administered via Turbuhaler and via pMDI. Efficacy and safety variables were measured before and during 6 h after each dose.The first study was a four-way crossover study including 12 patients. The salbutamol doses given were: 50, 100 and 2×100 µg via Turbuhaler and 2×100 µg via pMDI (Ventolin®). The study showed that 2×100 µg of salbutamol inhaled via Turbuhaler is more potent than 2×100 µg salbutamol inhaled via a pMDI, and that 100 µg salbutamol via Turbuhaler is at least as potent as 2×100 µg salbutamol inhaled via a pMDI.The second study including 50 patients was a placebo-controlled five-way crossover, study. Two doses of salbutamol via Turbuhaler, 50 and 2×100 µg, and via pMDI, 100 and 2×200 µg, were given. There was a dose-dependent response in forced expiratory volume in one second (FEV1) for both inhalers. Adjusted for differences in baseline FEV1 values, the estimated relative dose potency for Turbuhaler versus pMDI was 1.98:1 (95% confidence interval 1.2-3.2).These studies showed that the same bronchodilating effect can be achieved when half the dose of salbutamol given via a conventional pressurized metered-dose inhaler is given via Turbuhaler. Eur Respir J 1997; 10: 2474-2478 The pressurized metered-dose inhaler (pMDI) is the most widely used device for administering inhaled salbutamol, although dry-powder formulations dominate in a few countries. A substantial number of patients do not use their pMDIs optimally, the main problem being difficulties with co-ordination between the actuation of the dose and inhalation [1]. In addition, the chlorofluorocarbons (CFCs) used as propellants and lubricants are suspected of causing bronchoconstriction in some asthmatic individuals [2,3]. Furthermore, CFC propellants are harmful to the environment. Restrictions on the use of pMDIs are currently being implemented in several countries.To overcome co-ordination problems and other drawbacks with pMDIs, inspiratory flow-driven, dry-powder inhalers (DPIs), e.g. Rotahaler® and Diskhaler® (both Glaxo Wellcome Operations, Greenford, Middlesex, UK), have been developed. Turbuhaler® (Astra Pharmaceutical Production AB, Södertalje, Sweden) is an inspiratory flow-driven multidose DPI [4]. Studies have shown that Turbuhaler deposits a higher fraction of the dose in the lung than do pMDIs or the earlier DPIs [5][6][7][8][9]. Results from a cumulative dose-response study indicated that salbutamol inhaled via Turbuhaler gives better bronchodilating effect than salbutamol inhaled via a pMDI [10].The aim of the two single-dose studies presented here was to establish the dose potency ratio for salbutamol given via Turbuhaler compared with via a pMDI. In the first study, the lower dose of salbu...

Background:  The majority of Swedish birch pollen (BP)‐allergic patients report hypersensitivity to some fruits, nuts and vegetables. Some BP‐allergic patients complain ‘I can’t tolerate any fruit’. The main aim of the present study was to answer the question, ‘can BP‐allergic patients tolerate some of the exotic fruit, not at present common in Sweden?’ Methods:  Consecutive patients (n = 397) visiting the participating Allergy Clinics, who had a BP allergy and reported a food hypersensitivity, were asked to fill out questionnaires regarding 66 different fruits and vegetables. Subjects had three alternatives as an answer to each of the food questions: (i) ‘I tolerate it’; (ii) ‘I get symptoms from it’; or (iii) ‘I have not tried this food’. Skin prick tests were performed with pollen allergens. Results:  Most patients had experienced reactions to several foods; only 31 patients (8%) reported hypersensitivity to one food only. Some of the fruit had been tried by only a few patients. In addition to earlier well‐known BP‐related foods, more than 40% of patients who had knowingly eaten Japanese pear and pomegranate said that they had experienced symptoms after eating the fruit. Most patients tolerated pineapple, melon, grapes and citrus fruits, as well as zucchini, lychee, rambutan, mangosteen, ugli, melon pear and cherimoya. Conclusions:  Although an allergy to fruit is common among BP‐allergic patients, there are several widely available fruits that most patients tolerate; for instance, pineapple, melon, grapes and citrus fruit. Furthermore, there are many exotic fruits that most patients have not yet tried.

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