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Turner RB, Wecker MT, Pohl G, et al. Efficacy of Tremacamra, a Soluble Intercellular Adhesion Molecule 1, for Experimental Rhinovirus Infection: A Randomized Clinical Trial. JAMA. 1999;281(19):1797–1804. doi:10.1001/jama.281.19.1797
Author Affiliations: Departments of Pediatrics and Laboratory Medicine, Medical University of South Carolina, Charleston (Dr Turner); Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Conn (Drs Wecker, Pohl, Witek, and McNally, and Mr St. George); and Departments of Otolaryngology (Dr Winther) and Internal Medicine and Pathology (Dr Hayden), University of Virginia Health Sciences Center, Charlottesville.
Context Attachment of most rhinovirus subtypes to cells
depends on a cellular receptor, the intercellular adhesion molecule 1
(ICAM-1). A recombinant soluble ICAM-1 (tremacamra, formerly BIRR 4)
has shown possible efficacy in early studies.
Objective To determine the efficacy and safety of intranasal
administration of tremacamra in experimental rhinovirus colds in
Design Four randomized, double-blind, placebo-controlled trials
conducted in January to March 1996.
Setting and Subjects Volunteers between the ages of 18 and
60 years who had an antibody titer of 1:4 or less to the challenge
virus. Subjects were isolated in a hotel room during study days 0 to 8;
symptoms were recorded through day 14. A total of 198 subjects were
randomized, of whom 196 received drug or placebo and were included in
the safety analysis. A total of 177 subjects were included in the
Interventions Tremacamra or placebo was given beginning 7 hours
before inoculation with rhinovirus type 39 (preinoculation studies) or
12 hours after (postinoculation studies). Tremacamra as an inhaled
solution or as a powder (each given preinoculation and postinoculation
for a total of 4 studies) and placebo were given in 6 doses at 3-hour
intervals daily during days 1 through 7. Recipients of active treatment
received 367 µg of tremacamra per nostril per dose for a total of 4.4
Main Outcome Measures Effect of tremacamra on infection, as
determined by virus isolation and seroconversion, and on illness, as
determined by symptom scores, clinical colds, and nasal mucus weights.
Treatment-by-study interaction was not significant, so results were
pooled for the main analysis.
Results A total of 88 (92%) of the 96 subjects in the placebo
groups and 69 (85%) of the 81 subjects in the active treatment groups
were infected (P=.19). For placebo vs
tremacamra, respectively, the total symptom score (± 95% confidence
interval [CI]) was 17.6 (± 2.7) vs 9.6 (± 2.9), the proportion of
clinical colds was 64/96 (67% ± 9%) vs 36/81 (44% ± 11%), and the
nasal mucus weight was 32.9 (± 8.8) g vs 14.5 (± 9.4) g
(P<.001 for all comparisons). Tremacamra was not associated
with adverse effects or evidence of absorption through the nasal mucosa
and did not interfere with development of neutralizing antibody.
Conclusion Tremacamra reduced the severity of experimental
rhinovirus colds. Whether tremacamra will be useful clinically will
require further study.
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