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Double‐Blind Comparative Trial of Nuelin Depot and TheoDur with Adjusted Dosage in Asthmatic Adults
Author(s) -
Langaker Kjell Erik,
Osmundsen Karin,
Bredesens Jan Erik,
Lunde Per Knut M.
Publication year - 1981
Publication title -
allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.363
H-Index - 173
eISSN - 1398-9995
pISSN - 0105-4538
DOI - 10.1111/j.1398-9995.1981.tb01862.x
Subject(s) - depot , medicine , double blind , asthma , double blind study , dosage form , pediatrics , pharmacology , placebo , alternative medicine , archaeology , history , pathology
Equivalent doses of two sustained release preparations of theophylline, Nuelin Depot and TheoDur, were compared in a double blind, cross‐over study. Twenty adult outpatients with COLD were given adjusted doses of the two preparations to reach a peak value of theophylline in steady state within the therapeutic range. The study consisted of two 14‐day periods and airway function parametres, plasma concentrations, asthma symptoms, and side effects were recorded the last day in each period. In addition morning PEER, use of beta 2 Stimulant aerosol and number of nightly attacks were recorded daily. As judged from the peak‐trough variation of 24.8 μmol for Nuelin Depot and 26.3 μmol/1 for TheoDur as well as the t max of 4.3 hours for Nuelin and 3.6 hours for TheoDur, both products produced a similar plasma profile. No statistically significant differences were found between the two preparations with respect to airway function parameters, relief of asthma symptoms, need for beta 2 ‐stimulant aerosol or side effects. In conclusion these two sustained release preparations should be considered equivalent for practical use.