Recently, many of the leading pharmaceutical companies have started marketing a combination of montelukast and bambuterol for management of childhood asthma. Montelukast is a Cys-leukotriene receptor antagonist. It has been proven to have a role in management of mild persistent asthma(1). However, recent trials have found it be either inferior to inhaled low dose fluticasone or not-inferior (equivalent) to fluticasone(2). Based on the available data, the current consensus guidelines from various professional bodies(3), montelukast is listed as an alternative to low dose inhaled steroids. It is also recommended as an add-on to inhaled steroids in moderate persistent asthma even though there is data to suggest inferiority to combination of inhaled corticosteroids and inhaled long acting beta-agonists(4). The recently updated guidelines from the British Thoracic Society(5) clearly mention inhaled corticosteroids as the first choice preventer drug.

Bambuterol is a bis-dimethylcarbamate prodrug of terbutaline that releases terbutaline into blood over a sustained period. In this respect, it is different from long acting beta agonists like salmeterol or formoterol. The drug has been demonstrated to have benefit in nocturnal symptoms(6). However, the drug does not find mention in any of the standard treatment guidelines.

Since montelukast has been recommended as an alternative therapy in mild persistent asthma, we can presume the combination of montelukast and bambuterol is targeted for therapy of moderate persistent asthma.

Montelukast with long acting beta agonists are not recommended for use in asthma (BTS). There are no published studies evaluating the combination. With the above discussion it is clear that this combination will be inferior to inhaled corticosteroids and long acting beta agonists.

Even though the combination has an advantage of oral administration, should we accept this as therapy for moderate persistent asthma? It is desirable that the regulatory authorities carefully review the available evidence before permission is granted for marketing such irrational combination.

S.K. Kabra,
Rakesh Lodha,
Department of Pediatrics,
AIIMS, New Delhi, India. 

1. Knorr B, Franchi LM, Bisgaard H, Vermeulen JH, LeSouef P, Santanello N, et al. Monte-lukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years. Pediatrics 2001; 108: E48.

2. Garcia MLG, Wahn U, Gilles L, Swern A, Tozzi CA, Poloset P. Montelukast compared with fluticasone, for control of asthma among 6- to 14-year-old patients with mild asthma: The MOSAIC study. Pediatrics 2005; 116: 360-369.

3. Global Strategy for Asthma Management and Prevention. NIH Publication No 02-3659 Issued January, 1995 (updated 2002). Management Segment (Chapter 7): Updated 2004 from the 2003 document. Accessible from www.ginasthma.org

4. Ringdal N, Eliraz A, Pruzinec R, Weber HH, Mulder PG, Akveld M, et al. The salmeterol/fluticasone combination is more effective than fluticasone plus oral montelukast in asthma. Respir Med 2003; 97: 234-241.

5. British Thoracic Society, Scottish Inter-collegiate Guidelines network. British guide-line on management of asthma. Accessible from http://www.enterpriseportal2.co.uk/file store/bts/asthmaupdatenov05.pdf. Accessed 30th November 2005.

6. Wallaert B, Brun P, Ostinelli J, Murciano D, Champel F, Blaive B, et al. A comparison of two long-acting beta-agonists, oral bambu-terol and inhaled salmeterol, in the treatment of moderate to severe asthmatic patients with nocturnal symptoms. The French Bambuterol Study Group. Respir Med 1999; 93: 33-38.