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Early Use of Inhaled Nedocromil Sodium in Children Following An

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Early Use of Inhaled Nedocromil Sodium in Children Following An 308 Thorax 1999;54:308–315 Early use of inhaled nedocromil sodium in children following an acute episode of asthma Thorax: first published as 10.1136/thx.54.4.308 on 1 April 1999. Downloaded from University Medicine, Southampton General Hospital, A M Edwards, J Lyons, E Weinberg, F Weinberg, J D Gillies, G Reid, C F Robertson, Southampton, UK P Robinson, M Dalton, P Van Asperen, C Wilson, J Mullineux, A Mullineux, P D Sly, A M Edwards M Cox, A F Isles PO Box 131, North Ryde, NSW 2113, Australia J Lyons Abstract and evening PEF, and the usage of rescue —Current guidelines on the inhaled bronchodilators; 53% of patients Allergy Unit, Red Background Cross Children’s treatment of childhood asthma recom- reported nedocromil sodium to be very or Hospital, 7700 mend the introduction of an anti- moderately eVective compared with 44% Cape Town, South inflammatory drug in children who have placebo. Improvement in asthma symp- Africa persistent symptoms and require regular toms, PEF, and reduction in use of rescue E Weinberg treatment with a bronchodilator. The eY- bronchodilators did not reach statistical F Weinberg cacy and safety of inhaled nedocromil significance until after six weeks of treat- Anglesea Paediatrics sodium (Tilade Mint aerosol) adminis- ment. Twenty two patients were with- Ltd, Hamilton, tered using a Fisonair spacer at a dose of drawn or dropped out during the New Zealand 4 mg three times daily was compared with treatment phase, 12 due to uncontrolled J D Gillies placebo in the treatment of asthmatic asthma or persistence of asthma symp- G Reid children aged 6–12 years who are sympto- toms, four due to suspected adverse drug Department of matic and recovering from an acute exac- reactions (nedocromil sodium 3 (head- Thoracic Medicine, erbation of asthma. aches 2, angio-oedema/urticaria 1), pla- Royal Children’s Methods—A group comparative, double cebo 1(persistent cough)), and six due to Hospital, Melbourne, blind, placebo controlled trial was per- non-treatment related reasons. Seventy Victoria 3052, formed in children who were recovering one adverse events were reported by 27 Australia C F Robertson from an acute episode of asthma following patients in the nedocromil group and 75 P Robinson treatment in the emergency department by 30 patients in the placebo group. M Dalton of the hospital or in children referred Conclusions—Asthma symptoms, use of from their general practitioner following a bronchodilators, and lung function can be Department of wheezing episode and documented evi- improved significantly in children recov- Respiratory Medicine, dence of at least two previous episodes of ering from an acute exacerbation of Royal Alexandra http://thorax.bmj.com/ Hospital for Children, wheezing. A two week baseline period on asthma or wheeze and currently receiving Parramatta, NSW existing bronchodilator treatment was fol- treatment with bronchodilators alone by 2124, Australia lowed by a 12 week treatment period on the addition of inhaled nedocromil so- P Van Asperen either nedocromil sodium (2 mg/puV)or dium at a dose of 4 mg three times daily C Wilson placebo. Both treatments were adminis- administered using a Fisonair holding chamber. Department of tered using a Fisonair spacer at a dose of ( 1999; :308–315) Paediatrics, Gabarone two puVs three times daily. Changes from Thorax 54 Private Hospital, baseline values in daytime asthma and Botswana Keywords: asthma; nedocromil sodium; childhood night time asthma symptom scores, usage on October 1, 2021 by guest. Protected copyright. J Mullineux asthma; spacer A Mullineux of rescue bronchodilators, mean peak expiratory flow (PEF) recorded twice TWVT Institute for daily on diary cards, patients’ opinion of The current international guidelines on the Child Health treatment, and withdrawals due to treat- management of asthma in children1 recom- Research, Princess ment failure were measured during the mend a stepwise approach in which children Margaret Hospital for primary treatment period (last six weeks with infrequent episodic asthma commence Children, West Perth, WA6872, Australia of treatment). treatment with intermittent short acting â2 P D Sly Results—One hundred and forty two chil- adrenergic drugs. Once these are used more MCox dren aged 6–12 years entered the baseline than three times a week, or exacerbations occur period. Sixty three were withdrawn due to more frequently than every 4–6 weeks, prophy- Royal Children’s failure to meet the entry criteria (18) or lactic treatment is indicated. Inhaled sodium Hospital, Brisbane 4029, Australia the criteria for asthma symptom severity cromoglycate is the first prophylactic com- A F Isles (15) or reversibility (9), because they pound to be introduced and inhaled cortico- developed uncontrolled asthma (2), be- steroids should be substituted if this fails to Correspondence to: cause they took disallowed treatment (2), control symptoms. In the UK either inhaled Dr A M Edwards, 7 Fallowfield Close, or for other non-trial related reasons (17). sodium cromoglycate or inhaled cortico- Caversham, Reading RG4 Seventy nine patients (46 boys) of mean steroids are recommended as the first line pro- 8NQ, UK. age 8.8 years entered the treatment pe- phylactic treatment. riod. There were significant diVerences in Nedocromil sodium is a chromone. It is the Received 30 March 1998 Returned to author the changes from baseline values during disodium salt of a pyranoquinoline dicarboxy- 22 May 1998 the last six weeks of treatment in favour of lic acid developed as an anti-inflammatory Revised manuscript received nedocromil sodium compared with pla- treatment for asthma2 and is administered from 20 November 1998 Accepted for publication cebo in the primary variables of daytime a metered dose inhaler in unit doses of 2 mg. It 9 December 1998 asthma and night time asthma, morning has been compared with sodium cromoglycate Nedocromil sodium in childhood asthma 309 in in vitro and in vivo models of asthma and has the children were randomised to receive been shown to be up to 10 times more treatment with either inhaled nedocromil potent.3–5 A number of clinical trials have been sodium or inhaled placebo for a period of 12 conducted in adult patients6–9 and a meta- weeks. Patients were seen by the investigator at Thorax: first published as 10.1136/thx.54.4.308 on 1 April 1999. Downloaded from analysis of all placebo controlled trials has the beginning and end of the baseline period shown that the drug is an eVective treatment and every two weeks during the trial. for adult asthma.10 However, there have been The trial was conducted according to the very few trials of this drug to date in children principles established by the declaration of with asthma. Helsinki (as modified in Tokyo in 1975, Venice Many children who attend hospital accident in 1983, and Hong Kong in 1989). As the trial and emergency departments with acute epi- was conducted in three countries, both the sodes of asthma are not receiving anti- clinical investigators and the nurses responsible inflammatory therapy. In addition, there are for patient recruitment and monitoring met on many asthmatic children under the care of their at least one occasion in order to ensure a com- general practitioners who have not been started mon understanding of the trial protocol. on anti-inflammatory treatment despite having recurrent episodes of wheezing. We therefore TEST MEDICATIONS decided to evaluate the eYcacy and safety of The test medications were administered from a nedocromil sodium in the treatment of chil- metered dose inhaler using a 750 ml spacer dren who had recently attended a hospital (Fisonair). As the active drug was yellow in emergency department with an acute episode colour, the spacers were made of yellow mate- of asthma, and symptomatic children referred rial in order to maintain blindness. The test by their general practitioners who had had a medications were either inhaled nedocromil recent episode of wheezing and were currently sodium (2 mg per puV) or placebo (containing receiving bronchodilator treatment alone. liquefied gas propellants and excipients only), administered at a dose of two puVs three times Methods daily. PATIENTS Patients were allowed to use inhaled bron- Patients with asthma of either sex aged 6–12 chodilators as needed to control acute attacks years were eligible for selection. Those with a of wheezing or bronchospasm. The number of history of renal, hepatic, or cardiovascular dis- doses they required over each 24 hour period ease, or chronic respiratory disease other than was recorded on the daily diary card. The asthma were excluded. Patients had either had inhaled bronchodilators could be administered a recent episode of asthma treated at hospital via a metered dose inhaler, a dry powder deliv- or were referred by their general practitioner ery system, or an aqueous nebuliser. Oral with a current episode of wheeze and with bronchodilators were not allowed. Patients documented evidence of at least two previous were allowed to use topical nasal and/or http://thorax.bmj.com/ episodes of wheeze in the previous six months. ophthalmic preparations or antihistamines as Asthma was defined as current wheeze with required for the relief of nasal and ophthalmic airways obstruction that is reversible by at least symptoms, but were not allowed to use any 15% or an increase in forced expiratory volume form of corticosteroid (apart from topical in one second (FEV1)of>140 ml following the corticosteroids to the skin) or any other inhalation of two puVs of a bronchodilator anti-asthma treatment. administered by a metered dose inhaler. All patients had to have a minimum score of asthma symptoms (22) on a daily diary card MEASUREMENTS on October 1, 2021 by guest. Protected copyright. during a two week baseline period. Patients and Patient diary cards their parents had to be co-operative, to keep a Throughout the trial, including the baseline daily diary card for the duration of the trial, and period, parents kept a daily diary card on which to be able to use a pressurised metered dose they recorded the severity of daytime and night aerosol, a peak flow meter, and a spacer time asthma symptoms, the morning and (Fisonair).
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