Faculty Collaboration Database

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. J Allergy Clin Immunol 1998 Jan;101(1 Pt 1):7-13

Date

02/04/1998

Pubmed ID

9449494

DOI

10.1016/S0091-6749(98)70186-1

Scopus ID

2-s2.0-0031940540 (requires institutional sign-in at Scopus site)   15 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.

Author List

Blumenthal MN, Casale TB, Fink JN, Uryniak T, Casty FE

MESH terms used to index this publication - Major topics in bold

Administration, Inhalation
Adolescent
Adult
Aged
Anti-Asthmatic Agents
Asthma
Child
Chlorofluorocarbons
Cromolyn Sodium
Double-Blind Method
Female
Fluorocarbons
Humans
Hydrocarbons, Fluorinated
Male
Middle Aged
Spirometry