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Summary A double blind controlled trial of a house mile fortified house dust vaccine was carried out in forty-two asthmatic patients between the ages of 6 and 15 years. Improvement in height and weight was shown in eight of twenty-one children receiving the active therapy compared with one of twenty-one children receiving placebo injections. No difference between the two groups was shown by respiratory function testing or chest examination.

SummaryA double-blind trial of reserpine and propranolol as adjuncts in the treatment of hyperthyroidism is described. Eighteen previously untreated hyperthyroid patients took part in the trial on an out-patient basis. Reserpine was given on an oral dosage of 0.25 mg. 4-times daily while propranolol was given on an oral dosage of 40 mg. 4-times daily; each drug was given for a period of 2 weeks. There was no significant difference in the effect of reserpine and propranolol on the symptoms, signs and certain investigations of hyperthyroidism. Two patients on reserpine complained of diarrhoea while 3 patients on propranolol had insomnia. It is concluded that the choice between reserpine and propranolol as an adjunct in the treatment of hyperthyroidism is dependent on their side-effects; bronchial asthma is the major contra-indication to propranolol while mental depression is the major contra-indication to reserpine.

Summary The results of a double-blind crossover trial with Intal Compound (disodium cromoglycate and isoprenaline) in 62 asthmatic subjects is reported. Patients were given Intal Compound for six weeks and a placebo inhalation containing isoprenaline for six weeks. Forty-five patients were assessed as being better during one of the two six-week trial periods. Forty of the forty-five patients who showed improvement had been receiving the active preparation (Intal) at the time they showed improvement. All eleven patients who were assessed as showing great improvement had been having the active drug. It is concluded that disodium cromoglycate appears to afford complete protection to a few asthmatics and partial protection to many.

Because of several controversial reports concerning the efficacy of cromolyn sodium in the treatment of asthma, the Drug Committee of the American Academy of Allergy instituted a collaborative study in November, 1969. The protocol was designed to select patients according to age, cooperativeness, severity of asthma, and type of asthma—extrinsic, intrinsic, or mixed. The basic design of the study involved a baseline period of one week in which inert filler (lactose) was administered in the Spinhaler apparatus and during which the patient could be familiarized with the complex record keeping. The basal period was followed by two 4 week crossover periods during which cromolyn sodium was alternated with placebo. Symptom scores, drug intake, physician evaluation, patient preference, and simple pulmonary function tests were subjected to statistical analysis. Results gleaned from 252 completed patients indicated a favorable response for the drug as compared to placebo in patient symptom scoring, ephedrine-like drug scores, physician evaluation, and patient preference. A drug carry-over effect extending over a period of 4 weeks created difficulty in assessing results of the placebo period in patients who received active drug during the first 4 week period. Although a favorable drug effect was usually observed when cromolyn sodium was the first drug in the trial sequence, efficacy was more clear-cut during active drug administration in patients who received placebo during the first 4 weeks of the study. The mechanism of this carry-over effect was not apparent. The amelioration index tended to be higher in the pediatric group and in those patients whose asthma was classified as mixed. No change in the objective indices of one-second forced expiratory volume or peak expiratory flow measured once every 2 weeks was obtained. No serious side effects were noted by the participating investigators. These results indicate that cromolyn sodium will be a useful adjunct to the pharmacological treatment of asthma.

Ventilatory function after three types of exercise-running, cycling, and swimming-was studied in 10 control subjects and 40 asthmatic patients. All performed eight minutes of submaximal aerobic exercise during each of the programmes, which were conducted in a randomly selected order. Biotelemetric monitoring of heart rates was used to equate the intensity of the exertion undertaken during the three systems of exercise. No control subject showed any significant variation in ventilatory capacity after exercise, and the responses after the three forms of exercise did not differ.In asthmatics exercise-induced asthma was observed after 72.5% of running tests, 65% of cycling tests, and 35% of swimming tests. In addition, those patients who developed exercise-induced asthma after swimming were noted to have significantly smaller falls in FEV(1) levels than were recorded after running and cycling. These results were statistically significant (P

Betamethasone valerate aerosol is a new compound for the treatment of asthma. Its clinical effectiveness was established in a double-blind cross-over trial in non-steroid-dependent asthmatic patients. At a dosage of 400 to 800 mug/day for three months there was no evidence of suppression of hypothalamic-pituitary-adrenal function, as assessed by tetracosactrin and insulin stress tests.A 12-month follow-up study of 120 patients using steroid aerosols (betamethasone valerate or beclomethasone dipropionate) indicated that tolerance does not develop and that a daily maintenance dose of 200 mug/day was adequate in most patients. Temporary lack of response was observed during episodes of sputum production or of heavy exposure to antigen.There were no observed side effects other than fungal infections of the respiratory tract. However, the incidence of candidiasis of the pharynx (13%) and particularly of the larynx (5%) in apparently immunologically normal patients was disturbing. These infections were not seen in patients taking 200 mug/day. Though there is yet no evidence that fungal infections associated with steroid aerosols may penetrate the trachea and bronchi the possibility of this indicates that caution should be exercised in their use, particularly in long-term high dosage.

Excerpt Informed opinion is becoming increasingly aware that there are two main types of obstructive airway disease: asthma and the bronchitis emphysema complex (1). Nevertheless, not infrequently ...

Summary 1. A double blind trial of mebrophenydramine and an inactive preparation has been carried out on 50 asthmatic patients. The clinical impression and statistical analysis indicate that the active drug is better than placebo. 2. Thirteen of the 25 patients responded over the course of a fortnight to mebrophenhydramine and 2 of these had complete relief of symptoms. In the “placebo” group only 3 improved. 3. The only side effect reported was drowsiness which occurred in 3 patients, but the degree of this did not affect their work. 4. It is concluded that this is a useful drug with which to treat asthmatic patients and the results warrant further study in this condition.

Beclomethasone dipropionate inhalation (400 μg daily) was compared with placebo inhalations by means of a blind crossover trial in 20 asthmatics under consideration for maintenance corticosteroid therapy. As it was found to be helpful in controlling the symptoms of asthma, to improve peak flow rate and to reduce bronchodilator aerosol use, it was concluded that beclomethasone dipropionate is useful in the management of asthma.

SummaryThe effectiveness of two beta2 stimulant drugs, salbutamol and terbutaline, when given orally have been compared in terms of dynamic lung volumes, pulse rate and blood pressure. The recommended doses were used and were compared with placebo in a double-blind controlled trial. Both drugs improved the FEV1 and FVC equally and their length of action was the same, lasting approximately 5 hours. Comparisons between bronchodilator and placebo responses suggested bronchodilators not only reduced airflow obstruction but sustained both FEV1 and the response to further bronchodilator treatment. The problems of patient selection are discussed.

In a double-blind study 10 patients with chronic asthma received beclomethasone dipropionate 400 mug daily in a Freon propellant from a pressurized dispenser, and 10 patients received the Freon propellant alone. At the start of the trial each patient was receiving long-term maintenance treatment with oral prednisolone in a dose of 7.5 to 15 mg daily. The daily dose of prednisolone was reduced by 1 mg every four weeks and the patient's progress followed by regular clinical assessment and studies of pituitary-adrenal function. The trial was continued until the dose of prednisolone was reduced to zero or until asthmatic symptoms increased to an unacceptable level.In the 10 patients who received beclomethasone the mean maintenance dose of oral prednisolone was reduced by 5.6 mg/day but in only two cases could this drug be withdrawn completely. In the placebo group the mean reduction in dose was only 1.3 mg, thus there was a significant difference between the two groups (P

A double-blind cross-over trial of disodium cromoglycate in 21 patients with allergic bronchial asthma confirmed the value of the drug for this condition. Continuing benefit was shown on successive exposures. The drug proved more valuable in patients under fifty years of age and without bronchitic symptoms.

(1940), since whenithas beenusedextensively. Although takensublingually isoprenalineisan effective bronchodilator; itisnot active when swallowed. Sinceitisrapidly metabolized itsduration of action isshort, andunpleasant side-effects may occur. For these reasonsa bronchodilator without thesedisadvantages, butwithcomparable clinical effectiveness, was sought, and orciprenaline, a chemically similar compound, was foundto fulfil thesecriteria inlaboratory animals (Engelhardt etal., 1961). Orciprenaline ("alupent ")isa racemic isomeric mixture differing onlyfromisoprenaline inhavingboththehydroxyl groupsofitsbenzeneringinthemeta position, whileisoprenaline hasone ofthese groups inthepara position. Spitzbarth andAlbers (1961) claimed thattachycardia and myocardial irritability withresultant arrhythmias were much less easily produced withorciprenaline thanwithisoprenaline. They alsoreportedthatorciprenaline had a longer duration of actionand causedlessintestinal upset. Beynon-Jones (1962) andDrewitt (1962) claimed satisfactory clinical response to orciprenaline 40-80mg. dailyin patients withasthmaor chronicbronchitis. Myersand Coltman(1963), ina double-blind controlled trial ingeneral practice, foundthatorciprenaline 60 mg. dailycompared favourably withephedrine hydrochloride 180mg. dailyin patients withasthma or chronic bronchitis. PlanofTrial Theinvestigations were designed to assessthetoxicity of orciprenaline, todetermine itsvalueincontrolling reversible bronchospasm or airwaysobstruction, and to assess its clinical effectiveness inrelieving wheezing inthechronic

Twenty patients suffering from pronounced and stable bronchial asthma have been treated with disodium cromoglycate (DSCG) and placebo in a double-blind crossover trial. Significant improvement was obtained in subjective scores as well as in the lung function measured by vital capacity and forced expiratory volume (1 sec) during treatment with DSCG compared to placebo. Toxic effects on the heart, bone marrow, liver or kidneys were not demonstrated. The effect of DSCG was generally modest, but in a few patients the drug had a considerable and clinically relevant effect.

SummaryA double-blind crossover trial of fenfluramine and placebo tablets, each given for 8 weeks, was conducted on 38 obese asthmatic patients on long-term corticosteroid therapy. The mean weight loss of 2.04 kg. during the period of fenfluramine administration was statistically significant. Side-effects of treatment were on the whole mild, but one patient developed a confusional state associated with gross cerebral dysrhythmia.