Correspondence to: Dr. Arun Gupta, Secretary, Society for Asthma Care and Research, G 303, Rashmi Apartments, Harsh Vihar, Pitampura, Delhi 110 034, India.

This position statement is the result of a review of currently available scientific and objective data on the subject by the expert group (Annexure 1). The position statement was finalized by correspondence and no formal meeting of expert group was held.

Over the past ten years there has been paradigm shift in the understanding of the pathophysiology of asthma, from that of a disease marked by acute exacerbations to a disease characterized by chronic inflammation. Comprehensive pharmacological therapy for long-term management of asthma aims to reverse and prevent the airway inflammation and to manage acute exacerbations of asthma. Therefore, asthma drugs are divided in two broad categories: (i ) Quick relief drugs (bronchodilators); and (ii ) Long-term controller drugs (anti-inflammatories).

In a review of 94 studies(1), all reports recommended short acting inhaled beta-2 agonists as the first line treatment of acute exacerbations of asthma and inhaled cortico-steroids as the drug of choice when regular long-term therapy is needed. The current global guidelines recommend that short acting beta-2 agonists serves as a useful indicator of the severity of asthma and helps to decide the need for additional long-term controller medica-tion(2,3). Contrary to the recommendations, inhaled short acting beta-2 agonists still seem to be the most popularly used drug, combination drugs were only the second most popular regimen among young asthmatics(4). The use of fixed combinatins was found to be three times the use of preventers (3.7 million usage days vs 1.35 million usage days unpublished Society for Asthma Care and Research data). Regular use of short-acting beta-2 agonists or their combinations with inhaled steroids in asthma patients becomes a matter of serious concern.

Such a use could be potentially harmful to the patient as it may be associated with increased morbidity and mortality due to asthma because of poor asthma control and because of the delay in seeking medical advice during acute episodes(5). The partial control that these agents provide prevents a correct assessment of the degree of severity and risks involved. Disadvantages also include increased bronchial hyper-reactivity(6). In a double blind cross over study on stable asthma patients, morning and evening PEF rose a little more with the combination than with Budesonide alone, but there was no evidence of a difference in bronchial reactivity (AMP PD20) between the two treatment regimens over 2 weeks(7). There is little information available on relative benefits of such a combination and the individual constituents inhalers. In a double-blind crossover study on 68 adult patients with mild to moderate asthma, combination treatment did provide a significant improve-ment in morning and evening PEF as well as patient compliance over short acting beta-2 agonists or budesonide given alone during a period of four weeks(8). The limitation of the study was its duration, being only four weeks during which it is difficult to evaluate anti-inflammatory effects of inhaled steroids and the compliance.

Possible disadvantages of using ‘fixed’ combinations include:

1. Difficulties in classifying asthma severity– Since the frequency of use of beta-2 agonists serves as an indicator of the severity of asthma and the need for addi-tional anti-inflammatory therapy, combina-tion therapy may interfere with the classification of asthma severity leading to (i ) difficulties in stepping up and stepping down therapy; and (ii ) difficulties in the monitoring of asthma on a long-term basis.

2. Unnecessary overuse of these two drugs in stepwise management of asthma.

3. Poor control of nocturnal symptoms.

4. Potential of increased morbidity and mortality due to asthma.

Concerned over the adverse effects of the regular use of short-acting beta-2 agonists and their combination with inhaled steroids, considering that the use of such combinations is not consistent with the recommendations for long-term control of asthma, and recognizing that these are overused, the expert group feels that such a combination is unethical and irrational and therefore recommends:

1. That short-acting beta-2 agonists be used as per the global recommendations.

2. To the appropriate drug authorities and the State to take measures to ensure stricter control over the production and availability of such combinations.

3. That professionals be informed about the recent advances in management of asthma particularly pharmacotherapy: Overuse of short acting beta-2 agonists (more than 3-4 times during 24-hour period or one canister of 200 meter dose of salbutamol in a month) should serve as alarm to the doctor to review the medication plans of the patient. A slow withdrawal (in patients who are already on such combinations) of short-acting beta-2 drugs to the level recommended, or the usage of long acting beta-2 agonists instead of short acting ones be attempted.

4. To the manufacturers of these combina-tions to consider not to advocate the use of such combination to all categories of doctors and finally avoid marketing of such combinations.

Competing interests: None stated.

Funding: None.

Lata Kumar (Chandigarh), A.A, Mahasur (Mumbai), P.S. Shankar (Mumbai), Swati Y. Bhave (Mumbai), A.K. Prasad (Delhi), N.B. Kumta (Mumbai), Ajit Vigg, (Hyderabad), A.B. Singh (Delhi), U.P.S. Sidhu (Ludhiana), K.P. Kushwaha (Gorakhpur), Avdhesh Bansal (New Delhi), Harbans Bansal (Patiala), Meenu Singh (Chandigarh), K. Chugh (New Delhi), Raj K. Mani (New Delhi), Rita Gupta (Delhi), Arun Gupta (Delhi).