Largest Ever Asthma Trial Highlights Safety Of Pulmicort Treatment During Pregnancy

Main Category: Respiratory / Asthma
Article Date: 17 Dec 2005 - 18:00 PDT

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Five year results from the START trial (inhaled Steroid Treatment As Regular Therapy in early asthma), published today in Annals of Allergy, Asthma & Immunology, reveal that treating mild, persistent asthma during pregnancy with Pulmicort(TM) (budesonide) results in similar number of healthy children delivered in comparison to treatment with placebo1.

The START trial - the largest ever controlled asthma trial - involved 7,241 patients aged between 5 to 66 years, from over 32 countries. Of the 2,473 women in the trial, 313 pregnancies were analysed. For the first three years the trial was conducted as a randomised, double-blind study with patients receiving either 400ug of Pulmicort once daily or placebo, in addition to their usual asthma medication. The following two years of the study were conducted as an open-label period, with all patients receiving Pulmicort.

The pregnancy outcomes for Pulmicort versus placebo are as follows1:

-- A similar number of healthy children delivered (81% versus 77% placebo)

-- Similar low level of congenital abnormalities (3 [Pulmicort] versus 4 [placebo])

-- Similar adverse effects experienced by the women

Professor Michael Silverman, lead author of the study commented: "Inadequate control of asthma in pregnancy can very rarely have serious consequences, including higher rates of premature birth, lower birth weight and perinatal mortality. The START trial undoubtedly demonstrates that pregnancy outcomes when asthma is treated with Pulmicort, are similar to those of non-asthma sufferers." Professor Silverman continued: "Pulmicort had no adverse effects on the foetus or new-born. Results of the START study therefore show that budesonide is well-tolerated both in adults and when used in low doses during the full course of pregnancy."

Treatment guidelines such as GINA (Global Initiative for Asthma) have advocated the wider use of inhaled corticosteroids in mild persistent asthma for a number of years2, but in practice many physicians choose to wait until the disease becomes more severe before initiating treatment with inhaled corticosteroids. START provides powerful evidence to support the guidelines and the data also mirrors the recently updated National Asthma Education and Prevention Program (NAEPP) guidelines, which support the use of budesonide in pregnant women3.

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-- Pulmicort (budesonide) is an inhaled corticosteroid indicated for maintenance treatment of asthma in children and adults.

-- Pulmicort was first registered and launched in 1981 and is now approved in 89 countries. Pulmicort is available in three administration forms, a dry powder inhaler (Pulmicort Turbuhaler"), as a nebulising suspension (Pulmicort Respules") and as a pressurized Metered-Dose inhaler (Pulmicort pMDI).

-- START is a large worldwide study with robust results directly applicable to everyday clinical practice. Newly revealed data from the trial reinforce previous findings published in the Annals of Allergy, Asthma and Immunology earlier this year (Sheffer et al, 2005), demonstrating Pulmicort is well-tolerated in pregnant women and for the long-term treatment of asthma in both adults and children.

-- Both Pulmicort Turbuhaler and Pulmicort Respules are the only inhaled corticosteroids to be given a category B pregnancy rating by the United States Food and Drug Administration.

-- Pulmicort is a trademark of the AstraZeneca group of companies

References
1- Silverman M, Sheffer A, Diaz P, Lindmark B, Radner F, Broddene M, Gerhardsson de Verdier M, Pedersen S and Pauwels R. Outcome of pregnancy in a randomised controlled study including women with asthma exposed to budesonide: results of the inhaled Steroid Treatment as Regular Therapy in early asthma (START) study. Annals of Allergy, Asthma & Immunology, 2005, 95(6):566-570.
2- National Institute for Health, National Heart Lung and Blood Institute. Global Initiative for Asthma (GINA). Publication number 02-3659, 2002. http://www.gina.
3- Quick Reference from the Working Group Report on Managing Asthma During Pregnancy: Recommendations for Pharmacologic Treatment, Update 2004. http://www.nhlbi.nih.gov/health/prof/lung/asthma/astpreg/astpreg_qr.pdf (pages 2-3).
4- Sheffer AL, Silverman M, Woolcock AJ, Diaz PV, Lindberg B, Lindmark B. Long-term safety of once-daily budesonide in patients with early-onset mild persistent asthma: results of the Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START) study. Annals of Allergy, Asthma, & Immunology 2005;94(1):48-54.