The Efficacy & Safety of Once Daily Pulmicort Respules™ (Budesonide Nebulizing Suspension; BNS) and Placebo (PBO) in Infants and Young Children with Persistant Asthma † 1948
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Summary Aim : To assess the efficacy and safety of budesonide capsules 6 mg daily for prolongation of time to relapse and maintenance of remission in patients with Crohn's disease (CD) affecting the ileum and/or ascending colon. Methods : In a double‐blind, placebo‐controlled, multicentre trial, 110 patients with CD, who had previously achieved remission in a placebo‐controlled trial of budesonide 9 mg daily, were randomly assigned to receive budesonide 6 mg once daily or placebo for 52 weeks. Primary outcome measure was time to relapse [CD activity index (CDAI) of >150 plus an increase of at least 60 points from study entry or withdrawal due to clinical deterioration]. Results : Median time to relapse was 360 days for budesonide patients; 169 days for placebo patients ( P = 0.132). No significant differences were seen between groups in relapse rates at 1 year. Budesonide was safe and well tolerated, with a similar adverse events profile to placebo. Conclusion : Patients treated with budesonide 6 mg once daily had a trend towards a prolonged time to relapse and lower CDAI scores compared with patients treated with placebo, but relapse rates were not significantly different at the 1‐year end point.
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To the Editor:—
I read the paper entitled "Bronchial Asthma as a Complication of Pregnancy" by Dr. Bradford Green (The Journal, February, 3, p. 360) and also the communication in Correspondence (April 14, p. 1248) from Dr. R. H. Kampmeier, and would like to comment on Dr. Kampmeier's letter. His contention that allergic manifestations disappear during pregnancy, in contradiction to Dr. Green's experience that there is aggravation of asthma during pregnancy, is also borne out by my experience of an interesting case. A woman, aged 28, had had severe attacks of bronchial asthma for the past eight years. During pregnancy she was free of all symptoms of asthma and this absence of symptoms continued till three weeks post partum. When she was 30, I delivered her of her eighth child. All lived. The pregnancies occurred about one year apart to relieve her of her asthma. All the customary skin testingPost partum
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Recent advances in our knowledge of human sensitization to foreign proteins have opened numerous avenues of approach to the studies of symptom-complexes such as asthma, vasomotor rhinitis and obscure gastrointestinal disorders, as well as cutaneous manifestations of the type of angioneurotic edema, urticaria, and eczema. That these conditions are not infrequently external evidences of cellular disturbances dependent on a varied protein intoxication is now generally conceded. That the mechanism of such disturbance differs, however, from the usual immunologic processes as seen in anaphylaxis and infections is evidenced by the attempts, unsuccessful, with few exceptions, to demonstrate experimentally antibody formation to the foreign proteins by the usual laboratory methods. These peculiar states of hypersensitiveness have been characterized as "allergy," a term first applied by von Pirquet,1and recently "atopy" by Coca and Cooke.2 One of the most important of this group of diseases, asthma, has confused medical literature a
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