Evaluation of a non-chlorofluorocarbon formulation of cromolyn sodium (Intal) metered-dose inhaler versus the chlorofluorocarbon formulation in the treatment of adult patients with asthma: A controlled trial

Malcolm N. Blumenthal, Thomas B. Casale, Jordan N. Fink, Thomas Uryniak, Frank E. Casty

Research output: Contribution to journalArticlepeer-review

14 Scopus citations

Abstract

Background: Cromolyn sodium is a nonsteroidal inhaled antiinflammatory agent for the treatment of asthma. As with other pressurized aerosol medications, the metered-dose inhaler (MDI) formulation currently contains chlorofluorocarbon (CFC) propellants. Because of their harmful effects on the environment CFCs are now generally banned from production and use. Alternative propellants under production for MDIs include derivatives of hydrofluoroalkane (HFA). This study uses HFA-227 in an MDI formulation of cromolyn sodium. Objectives: The objectives of the study were (1) to examine the efficacy and safety of an HFA formulation of cromolyn sodium (Intal) MDI and (2) to compare the HFA formulation with the CFC formulation. Methods: A multicenter, randomized, double-blind, placebo-controlled, parallel study with two active groups (HFA-cromolyn sodium [n = 113] and CFC-cromolyn sodium [n = 107]) and a placebo-treated group (n = 105). Results: Patients treated with either formulation of cromolyn sodium MDI showed a statistically significant (p < 0.05) improvement of 12% to 18% compared with placebo in symptom summary score, daytime asthma symptoms, and albuterol use. No statistically significant differences were observed in pulmonary function. Patient and physician opinions of overall effectiveness favored HFA-cromolyn sodium over placebo (p = 0.01), with no other significant between-treatment differences. No statistically significant differences existed among groups in the incidence of treatment-related adverse events. Conclusion: The HFA formulation of cromolyn sodium MDI is a well- tolerated and active alternative treatment for asthma patients aged 12 years and more.

Original languageEnglish (US)
Pages (from-to)7-13
Number of pages7
JournalJournal of Allergy and Clinical Immunology
Volume101
Issue number1
DOIs
StatePublished - 1998

Bibliographical note

Funding Information:
Supported by a grant from Rhone Poulenc Rorer Pharmaceuticals.

Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.

Keywords

  • Chlorofluorocarbon
  • Cromolyn sodium
  • Hydrofluoroalkane
  • Metered-dose inhaler
  • Montreal Protocol
  • Ozone

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