Disodium Cromoglycate(CAS 15826-37-6) is an antiallergic drug with IC50 of 39 μg/mL. It has been shown to be an effective inhibitor of experimental allergen-induced bronchoconstriction in asthmatics.
1. Expert Opin Drug Deliv. 2011 Jan;8(1):1-17. doi: 10.1517/17425247.2010.542141.
Have inadequate delivery systems hampered the clinical success of inhaled disodium cromoglycate? Time for reconsideration.
Keller M(1), Schierholz J.
(1)PARI Pharma GmbH, Aerosol Research Institute, Lochhamer Schlag 21, D-82166 Graefelfing, Germany. [email protected]
IMPORTANCE OF THE FIELD: Disodium cromoglycate (DSCG) fits with the perception of a safe drug, but conclusions from questionable meta-analyses reduced its use. In addition, drug delivery aspects, such as hygroscopicity and the poor performance of delivery systems, were not considered to be important determinants of therapeutic failures.
AREAS COVERED IN THIS REVIEW: Drug delivery aspects and parameters affecting lung deposition and distribution, important parameters for therapeutic efficacy, are addressed. In addition, the distribution and ratio of mast cell tryptase and chymase-positive phenotypes in the lungs and their role in the prostaglandin and leukotriene pathway are discussed.
WHAT THE READER WILL GAIN: Information on why in vitro data are an excellent tool to understand better therapeutic failures associated with the moisture sensitivity of DSCG and the difficulty in handling and operating DSCG delivery systems in a therapeutically reliable way.
TAKE HOME MESSAGE: Pharmacological efficacy of DSCG has been demonstrated in animals and humans. If the drug is delivered to the site of inflammation in an effective dose, a reliable therapeutic effect can be expected. DSCG has extra properties and potential unspecific antiviral properties and may offer new therapeutic treatment aspects for asthma and viral-induced bronchiolitis in early childhood.
2. Thorax. 2000 Nov;55(11):913-20. doi: 10.1136/thorax.55.11.913.
Inhaled disodium cromoglycate (DSCG) as maintenance therapy in children with asthma: a systematic review.
Tasche MJ(1), Uijen JH, Bernsen RM, de Jongste JC, van der Wouden JC.
(1)Department of General Practice, Erasmus University, 3000 DR Rotterdam, The Netherlands.
Comment in ACP J Club. 2001 Jul-Aug;135(1):24. Thorax. 2000 Nov;55(11):886. Thorax. 2001 Apr;56(4):331-2. Thorax. 2001 Jul;56(7):585. Thorax. 2001 Nov;56(11):896. Thorax. 2002 Mar;57(3):282. Thorax. 2002 Aug;57(8):751-2.
BACKGROUND: Disodium cromoglycate (DSCG) is included in the BTS guidelines on the treatment of asthma for use in children, but is now used only infrequently. We have identified and interpreted the findings of all published randomised, placebo controlled trials of DSCG in the prophylactic treatment of children with asthma.
METHODS: Several databases were searched to identify trials. Studies were included if they investigated subjects with asthma aged 0-18 years old, addressed maintenance treatment with inhaled DSCG, and were published in English. The methodological quality of the studies was assessed independently by three reviewers. The 95% confidence intervals (CI) of differences in the treatment effect for cough and wheeze between placebo and treatment with DSCG were computed. The estimates were pooled and tested for homogeneity and, to assess possible publication bias, a funnel plot was made and tested for symmetry.
RESULTS: Of the 24 randomised, placebo controlled trials identified, the methodological scores varied widely. The null hypothesis of homogeneity was rejected. Under the assumption of heterogeneity the overall CI for wheeze was 0.11 to 0.26 and for cough was 0.13 to 0.27. The overall tolerance intervals (-0.11 to 0. 48 and -0.04 to 0.43 for wheeze and cough, respectively) both included zero, so it cannot be concluded that future studies will show an effect of DSCG compared with placebo. Older studies were more often in favour of DSCG. The funnel plots suggest publication bias; small studies with negative or equal outcomes are lacking.
CONCLUSION: Given the apparent publication bias, the small overall treatment effect, and the tolerance interval including zero, there is insufficient evidence that DSCG has a beneficial effect as maintenance treatment in children with asthma.
3. Orr, T. S. C., and J. S. G. Cox. "Disodium cromoglycate, an inhibitor of mast cell degranulation and histamine release induced by phospholipase A." Nature 223.5202 (1969): 197-198.