Ineffectiveness of Recombinant Interferon-βserine Nasal Drops for Prophylaxis of Natural Colds
Two randomized, double-blind, placebo-controlled trials during early autumn of 1986 and 1987 evaluated the efficacy and tolerance of recombinant interferon-βserine (rIFN-βser) nasal drops for prevention of natural rhinovirus colds. In 1986, 9 × 106 units of rIFN-βser (139 subjects) or placebo (157)...
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| Published in | The Journal of infectious diseases Vol. 160; no. 4; pp. 700 - 705 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
The University of Chicago Press
01.10.1989
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0022-1899 1537-6613 |
| DOI | 10.1093/infdis/160.4.700 |
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| Abstract | Two randomized, double-blind, placebo-controlled trials during early autumn of 1986 and 1987 evaluated the efficacy and tolerance of recombinant interferon-βserine (rIFN-βser) nasal drops for prevention of natural rhinovirus colds. In 1986, 9 × 106 units of rIFN-βser (139 subjects) or placebo (157) were adminstered once daily except Sundays for 4 w. Rhinovirus colds occurred in 2.8% of rIFN-βser recipients and 6.0% of placebo recipients during the treatment period (52% reduction, P = .3). In 1987, 24 × 106 units of rIFN-βser (186) or placebo (197) were given daily for 25 consecutive days. Rhinovirus colds developed in 6.3% of rIFN-βser recipients and 5.3% of placebo recipients. In each study, illness frequency and number of days with subjective colds did not differ between the groups. Recipients of nasal drops of rIFN-βser at either dosage did not differ in tolerance from placebo recipients. The lack of both prophylactic efficacy and nasal toxicity are in contrast to prior observations with nasal sprays of rIFN-α2b. |
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| AbstractList | Two randomized, double-blind, placebo-controlled trials during early autumn of 1986 and 1987 evaluated the efficacy and tolerance of recombinant interferon-β
serine
(rIFN-β
ser
) nasal drops for prevention of natural rhinovirus colds. In 1986, 9 × 106 units of rIFN-β
ser
(139 subjects) or placebo (157) were adminstered once daily except Sundays for 4 w. Rhinovirus colds occurred in 2.8% of rIFN-β
ser
recipients and 6.0% of placebo recipients during the treatment period (52% reduction,
P
= .3). In 1987, 24 × 106 units of rIFN-β
ser
(186) or placebo (197) were given daily for 25 consecutive days. Rhinovirus colds developed in 6.3% of rIFN-β
ser
recipients and 5.3% of placebo recipients. In each study, illness frequency and number of days with subjective colds did not differ between the groups. Recipients of nasal drops of rIFN-β
ser
at either dosage did not differ in tolerance from placebo recipients. The lack of both prophylactic efficacy and nasal toxicity are in contrast to prior observations with nasal sprays of rIFN-α
2b
. Two randomized, double-blind, placebo-controlled trials during early autumn of 1986 and 1987 evaluated the efficacy and tolerance of recombinant interferon-beta serine (rIFN-beta ser) nasal drops for prevention of natural rhinovirus colds. In 1986, 9 X 10(6) units of rIFN-beta ser (139 subjects) or placebo (157) were administered once daily except Sundays for 4 w. Rhinovirus colds occurred in 2.8% of rIFN-beta ser recipients and 6.0% of placebo recipients during the treatment period (52% reduction, P = .3). In 1987, 24 X 10(6) units of rIFN-beta ser (186) or placebo (197) were given daily for 25 consecutive days. Rhinovirus colds developed in 6.3% of rIFN-beta ser recipients and 5.3% of placebo recipients. In each study, illness frequency and number of days with subjective colds did not differ between the groups. Recipients of nasal drops of rIFN-beta ser at either dosage did not differ in tolerance from placebo recipients. The lack of both prophylactic efficacy and nasal toxicity are in contrast to prior observations with nasal sprays of rIFN-alpha 2b.Two randomized, double-blind, placebo-controlled trials during early autumn of 1986 and 1987 evaluated the efficacy and tolerance of recombinant interferon-beta serine (rIFN-beta ser) nasal drops for prevention of natural rhinovirus colds. In 1986, 9 X 10(6) units of rIFN-beta ser (139 subjects) or placebo (157) were administered once daily except Sundays for 4 w. Rhinovirus colds occurred in 2.8% of rIFN-beta ser recipients and 6.0% of placebo recipients during the treatment period (52% reduction, P = .3). In 1987, 24 X 10(6) units of rIFN-beta ser (186) or placebo (197) were given daily for 25 consecutive days. Rhinovirus colds developed in 6.3% of rIFN-beta ser recipients and 5.3% of placebo recipients. In each study, illness frequency and number of days with subjective colds did not differ between the groups. Recipients of nasal drops of rIFN-beta ser at either dosage did not differ in tolerance from placebo recipients. The lack of both prophylactic efficacy and nasal toxicity are in contrast to prior observations with nasal sprays of rIFN-alpha 2b. Two randomized, double-blind, placebo-controlled trials during early autumn of 1986 and 1987 evaluated the efficacy and tolerance of recombinant interferon-beta serine (rIFN-beta ser) nasal drops for prevention of natural rhinovirus colds. In 1986, 9 X 10(6) units of rIFN-beta ser (139 subjects) or placebo (157) were administered once daily except Sundays for 4 w. Rhinovirus colds occurred in 2.8% of rIFN-beta ser recipients and 6.0% of placebo recipients during the treatment period (52% reduction, P = .3). In 1987, 24 X 10(6) units of rIFN-beta ser (186) or placebo (197) were given daily for 25 consecutive days. Rhinovirus colds developed in 6.3% of rIFN-beta ser recipients and 5.3% of placebo recipients. In each study, illness frequency and number of days with subjective colds did not differ between the groups. Recipients of nasal drops of rIFN-beta ser at either dosage did not differ in tolerance from placebo recipients. The lack of both prophylactic efficacy and nasal toxicity are in contrast to prior observations with nasal sprays of rIFN-alpha 2b. Two randomized, double-blind, placebo-controlled trials during early autumn of 1986 and 1987 evaluated the efficacy and tolerance of recombinant interferon-βserine (rIFN-βser) nasal drops for prevention of natural rhinovirus colds. In 1986, 9 × 106 units of rIFN-βser (139 subjects) or placebo (157) were adminstered once daily except Sundays for 4 w. Rhinovirus colds occurred in 2.8% of rIFN-βser recipients and 6.0% of placebo recipients during the treatment period (52% reduction, P = .3). In 1987, 24 × 106 units of rIFN-βser (186) or placebo (197) were given daily for 25 consecutive days. Rhinovirus colds developed in 6.3% of rIFN-βser recipients and 5.3% of placebo recipients. In each study, illness frequency and number of days with subjective colds did not differ between the groups. Recipients of nasal drops of rIFN-βser at either dosage did not differ in tolerance from placebo recipients. The lack of both prophylactic efficacy and nasal toxicity are in contrast to prior observations with nasal sprays of rIFN-α2b. |
| Author | Riker, Donald K. Levine, Paul A. Sorrentino, James V. Sperber, Steven J. Hayden, Frederick G. |
| AuthorAffiliation | From the Departments of Internal Medicine, Otolaryngology-Head and Neck Surgery, and Pathology, University of Virginia School of Medicine , Charlottesville From the Vicks Research Center , Shelton, Connecticut |
| AuthorAffiliation_xml | – name: From the Vicks Research Center , Shelton, Connecticut – name: From the Departments of Internal Medicine, Otolaryngology-Head and Neck Surgery, and Pathology, University of Virginia School of Medicine , Charlottesville |
| Author_xml | – sequence: 1 givenname: Steven J. surname: Sperber fullname: Sperber, Steven J. organization: From the Departments of Internal Medicine, Otolaryngology-Head and Neck Surgery, and Pathology, University of Virginia School of Medicine, Charlottesville, Shelton, Connecticut – sequence: 2 givenname: Paul A. surname: Levine fullname: Levine, Paul A. organization: From the Departments of Internal Medicine, Otolaryngology-Head and Neck Surgery, and Pathology, University of Virginia School of Medicine, Charlottesville, Shelton, Connecticut – sequence: 3 givenname: James V. surname: Sorrentino fullname: Sorrentino, James V. organization: From the Departments of Internal Medicine, Otolaryngology-Head and Neck Surgery, and Pathology, University of Virginia School of Medicine, Charlottesville, Shelton, Connecticut – sequence: 4 givenname: Donald K. surname: Riker fullname: Riker, Donald K. organization: From the Departments of Internal Medicine, Otolaryngology-Head and Neck Surgery, and Pathology, University of Virginia School of Medicine, Charlottesville, Shelton, Connecticut – sequence: 5 givenname: Frederick G. surname: Hayden fullname: Hayden, Frederick G. organization: From the Departments of Internal Medicine, Otolaryngology-Head and Neck Surgery, and Pathology, University of Virginia School of Medicine, Charlottesville, Shelton, Connecticut |
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| Notes | ark:/67375/HXZ-F36ZN3M1-S 1Please address requests for reprints to Dr. Frederick G. Hayden, Department of Internal Medicine, University of Virginia School of Medicine, Box 473, Charlottesville, VA 22908. The authors thank the nurses and technologists of the Respiratory Disease Study Unit, University of Virginia Medical Center, for technical assistance; Dr. Paul S. Lietman and Amina Woods, Division of Clinical Pharmacology, The Johns Hopkins University School of Medicine, for performing the 2′-5′ oligo-adenylate synthetase activity assays; Dr. Don Kaiser, Division of Information Sciences, University of Virginia, for statistical analysis; and Margaret Sipe for clerical assistance. istex:7C1987293F84BD603A3C758749CB1B0038BE8D18 ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3 Present address: UMDNJ-Robert Wood Johnson Medical School, New Brunswick, New Jersey. |
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| Snippet | Two randomized, double-blind, placebo-controlled trials during early autumn of 1986 and 1987 evaluated the efficacy and tolerance of recombinant... Two randomized, double-blind, placebo-controlled trials during early autumn of 1986 and 1987 evaluated the efficacy and tolerance of recombinant interferon-β... |
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| SubjectTerms | Administration, Intranasal Adult Clinical Trials as Topic Common Cold - prevention & control Concise Communications Double-Blind Method Female Humans Interferon beta-1a Interferon beta-1b Interferon Type I - administration & dosage Interferon Type I - therapeutic use Interferon-beta Male Random Allocation Recombinant Proteins - administration & dosage Recombinant Proteins - therapeutic use Rhinovirus Seasons |
| Title | Ineffectiveness of Recombinant Interferon-βserine Nasal Drops for Prophylaxis of Natural Colds |
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