Nedocromil sodium: a new drug for the management of bronchial asthma.

Abstract

ABSTRACr Nedocromil sodium (FPL 59002) is a pyranoquinoline dicarboxylic acid that has been developed for the management of bronchial asthma. We report the results of a double blind group comparative trial in which the disodium salt of nedocromil delivered by pressurised aerosol and a placebo were compared in the management of patients with a diagnosis of bronchial asthma who entered the double blind period on a minimum dose of beclomethasone dipropionate. In almost all the assessments of clinical activity nedocromil sodium was shown to be more effective than placebo. These include improvements in diary card symptom scores, reduction in concomitant use of a bronchodilator aerosol, and patients' and investigators' assessments of efficacy. Unwanted effects were few and mild. No patients were withdrawn from the trial.Nedocromil (FPL 59002) is a pyranoquinoline dicarboxylic acid (chemical name 9-ethyl-6, 9-dihydro-4,6-dioxo-10-propyl-4H-pyrano (3,2-g) quinoline-2,8-dicarboxylic acid) and its disodium salt (FPL 59002KP) was identified from a range of pharmacological and immunological tests as a compound worthy of clinical evaluation in asthmatic patients. In antigen challenge studies nedocromil sodium was shown to protect against the immediate reaction, and the results suggested that the compound may be useful in the treatment of bronchial asthma.We Nine patients were found to have minimal symptoms even when beclomethasone dipropionate was discontinued altogether. These patients were then managed with a 12 agonist only and did not take further part in the study. One group received nedocromil sodium at a dose of 4 mg (two inhalations of 2 mg from a pressurised aerosol) four times daily.The other group received two inhalations four times daily from an identical placebo pressurised aerosol containing the same propellants and surfactant but without the active drug. Both treatments were continued for 28 days. Before starting on the trial aerosols each patient completed a diary card for two weeks to establish baseline values. They rated symptoms of night time and daytime asthma, morning chest tightness, and cough on a 0-4 scale related to each symptom-for example, night asthma would be rated from 0 (undisturbed sleep) to 4 (being awake all night). Patients were supplied with a mini Wright peak flow meter and they recorded the best of three readings morning and evening on the diary card. They also recorded all medication taken, including the test medication.At each clinic visit the severity of the patient's 809 on 12 May 2018 by guest. Protected by copyright.

Effect of nedocromil sodium on sulphur dioxide induced bronchoconstriction.

“…Nedocromil sodium protects against exercise induced asthma,' antigen induced bronchoconstriction,2 antigen induced nasal obstruction,3 and bronchoconstriction caused by nonspecific stimuli.4 When administered four times daily for one month, it improves the control of bronchial asthma. 5 The profile of action of nedocromil sodium is similar to that of sodium cromoglycate. Since sodium cromoglycate protects against bronchoconstrictor responses to sulphur dioxide6 we have investigated whether nedocromil sodium 2 or 4 mg confers similar protection against sulphur dioxide induced bronchoconstriction when compared with matched placebo.…”

The pharmacokinetics of nedocromil sodium, a new drug for the treatment of reversible obstructive airways disease, in human volunteers and patients with reversible obstructive airways disease.

“…Nedocromil sodium is the disodium salt of a 1985; Shaw & Kay, 1985;Youngchaiyud & Lee, pyranoquinoline dicarboxylic acid which has been 1986) as well as being active in therapeutic trials developed as a new treatment (Tilade9, (Lal et al, 1984;Ruffin, 1986;Fairfax & Allbeson registered trade mark of Fisons plc) for reversible 1986). obstructive airways disease (Auty, 1986; A sensitive radioimmunoassay for nedocromil al., 1986).…”

The effect of nedocromil sodium and sodium cromoglycate on antigen‐induced bronchoconstriction in the Ascaris‐sensitive monkey

“…Preliminary studies in man have shown that nedocromil sodium reduces the symptoms of asthma and in addition it helps to relieve asthma in patients maintained on steroids (Lal et al, 1984). Further clinical work is needed to investigate the full potential ofthis new class ofdrug.…”