Comparison of 3 different doses of budesonide and placebo on the early asthmatic response to inhaled allergen

Veronica A. Swystun, Rajesh Bhagat, Sanjay Kalra, Barbara Jennings, Donald W. Cockcroft

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

Background: A simple laboratory method to evaluate relative potency of inhaled corticosteroids in asthma would be valuable. Single-dose studies with the allergen-induced late asthmatic response have failed to show a useful dose-response relationship. Treatment for several days with inhaled corticosteroids will also inhibit the allergen-induced early asthmatic response. Methods: Twelve atopic asthmatic subjects were studied during a season when no medications were required except ipratropium bromide as needed. These subjects had positive allergen and methacholine inhalation tests and FEV1 greater than 70% of predicted value. A double-blind, randomized, crossover study compared placebo and budesonide 100, 200, and 400 μg administered by means of Turbuhaler twice daily for 7 days with 6-day washout periods. Methacholine PC20 was measured before and after 6 days of treatment, and allergen PC15 was measured after 7 days of treatment. Results: The allergen PC15 (n = 11) was significantly larger (P = .0001) for all doses of budesonide compared with placebo, but there was no significant difference between the 3 doses of budesonide, and no dose response was demonstrated. The methacholine PC20 was significantly larger after all budesonide treatments compared with placebo (P = .024), but there was no difference between the 3 doses. There was a progressive increase in the allergen PC15 chronologically (sequence effect) that was not explained by improvement in FEV1 or airway responsiveness; sequence effects were not seen for FEV1 or for pretreatment or posttreatment methacholine PC20. Statistical adjustment for sequence effect did not alter allergen PC15 statistics. Conclusion: A 7-day course of budesonide administered by means of Turbuhaler at 200, 400, or 800 μg per day provided marked and significant inhibition of the allergen-induced early asthmatic response compared with placebo. There was, however, no difference between the 3 doses. Therefore this method with these doses is not useful for providing assessment of relative potency.

Original languageEnglish (US)
Pages (from-to)363-367
Number of pages5
JournalJournal of Allergy and Clinical Immunology
Volume102
Issue number3
DOIs
StatePublished - Jan 1 1998
Externally publishedYes

Fingerprint

Budesonide
Allergens
Placebos
Methacholine Chloride
Adrenal Cortex Hormones
Ipratropium
Therapeutics
Cross-Over Studies
Inhalation
Asthma

Keywords

  • Asthma
  • Bronchial allergen challenge
  • Corticosteroid
  • Dose-response

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Comparison of 3 different doses of budesonide and placebo on the early asthmatic response to inhaled allergen. / Swystun, Veronica A.; Bhagat, Rajesh; Kalra, Sanjay; Jennings, Barbara; Cockcroft, Donald W.

In: Journal of Allergy and Clinical Immunology, Vol. 102, No. 3, 01.01.1998, p. 363-367.

Research output: Contribution to journalArticle

Swystun, Veronica A. ; Bhagat, Rajesh ; Kalra, Sanjay ; Jennings, Barbara ; Cockcroft, Donald W. / Comparison of 3 different doses of budesonide and placebo on the early asthmatic response to inhaled allergen. In: Journal of Allergy and Clinical Immunology. 1998 ; Vol. 102, No. 3. pp. 363-367.
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AU - Cockcroft, Donald W.

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AB - Background: A simple laboratory method to evaluate relative potency of inhaled corticosteroids in asthma would be valuable. Single-dose studies with the allergen-induced late asthmatic response have failed to show a useful dose-response relationship. Treatment for several days with inhaled corticosteroids will also inhibit the allergen-induced early asthmatic response. Methods: Twelve atopic asthmatic subjects were studied during a season when no medications were required except ipratropium bromide as needed. These subjects had positive allergen and methacholine inhalation tests and FEV1 greater than 70% of predicted value. A double-blind, randomized, crossover study compared placebo and budesonide 100, 200, and 400 μg administered by means of Turbuhaler twice daily for 7 days with 6-day washout periods. Methacholine PC20 was measured before and after 6 days of treatment, and allergen PC15 was measured after 7 days of treatment. Results: The allergen PC15 (n = 11) was significantly larger (P = .0001) for all doses of budesonide compared with placebo, but there was no significant difference between the 3 doses of budesonide, and no dose response was demonstrated. The methacholine PC20 was significantly larger after all budesonide treatments compared with placebo (P = .024), but there was no difference between the 3 doses. There was a progressive increase in the allergen PC15 chronologically (sequence effect) that was not explained by improvement in FEV1 or airway responsiveness; sequence effects were not seen for FEV1 or for pretreatment or posttreatment methacholine PC20. Statistical adjustment for sequence effect did not alter allergen PC15 statistics. Conclusion: A 7-day course of budesonide administered by means of Turbuhaler at 200, 400, or 800 μg per day provided marked and significant inhibition of the allergen-induced early asthmatic response compared with placebo. There was, however, no difference between the 3 doses. Therefore this method with these doses is not useful for providing assessment of relative potency.

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