Randomised placebo-controlled crossover trial on effect of inactivated influenza vaccine on pulmonary function in asthma
Identifieur interne : 001A50 ( Main/Exploration ); précédent : 001A49; suivant : 001A51Randomised placebo-controlled crossover trial on effect of inactivated influenza vaccine on pulmonary function in asthma
Auteurs : Karl G. Nicholson ; Jonathan S. Nguyen-Van-Tam ; Ala'Eldin H. Ahmed ; Martin J. Wiselka ; Jane Leese [Royaume-Uni] ; Jon Ayres [Royaume-Uni] ; James H. Campbell ; Philip Ebden ; Noemi M. Eiser [Royaume-Uni] ; Bruce J. Hutchcroft ; James Cg Pearson ; Richard F. Willey ; Roger J. Wolstenholme ; Mark A. Woodhead [Royaume-Uni]Source :
- The Lancet [ 0140-6736 ] ; 1998.
English descriptors
- Teeft :
- Allergic rhinitis, Annual vaccination, Antibiotic, Asthma, Asthma exacerbation, Asthma exacerbations, Asthmatic, Asthmatic children, Background rate, Baseline, Baseline characteristics, Binomial test, Categorical data, Chronic asthma, Clinical investigators, Crossover, Crossover design, Daily activities, District hospital, Exacerbation, Excess mortality, Family practitioners, Febrile illness, First injection, Hospital admission, Hospital admissions, Infectious diseases, Infirmary, Influenza, Influenza vaccination, Influenza vaccine, Influenza virus, Influenza viruses, Inhaled, Injection, Lancet, Medical consultations, Medication, Methacholine sensitivity, None binomial test, Oral steroids, Other studies, Participant, Personal reasons, Placebo, Placebo test, Positive events, Possible order effects, Previous studies, Prince philip hospital, Pulmonary function, Respiratory symptoms, Royal albert edward infirmary, Second injection, Severe exacerbation, Significant difference, Significant differences, Significant test, Small numbers, Smoking status, Sputum colour, Sputum production, Substantial morbidity, Symptom, Symptom score, Symptomatic colds, Tropical medicine, Unstable asthma, Vaccination, Vaccine, Vaccine development, Vaccinee, Wilcoxon test.
Abstract
Summary: Background Despite current recommendations, many people with asthma do not receive annual vaccination against influenza, partly because of concern that vaccine may trigger exacerbations. Colds can trigger exacerbations, which may be mistaken for vaccine-related adverse events. We undertook a double-blind placebo-controlled multicentre crossover study to assess the safety of influenza vaccine in patients with asthma, with allowance for the occurrence of colds.Methods We studied 262 patients, aged 1875 years, who recorded daily peak expiratory flow (PEF), respiratory symptoms, medication, medical consultations, and hospital admissions for 2 weeks before the first injection and until 2 weeks after the second injection. Order of injection (vaccine and placebo) was assigned randomly. There was an interval of 2 weeks between injections. The main outcome measure was an exacerbation of asthma within 72 h of injection (defined as a fall in PEF of >20).Findings Among 255 participants with paired data, 11 recorded a fall in PEF of more than 20 after vaccine compared with three after placebo (McNemar's test p=006); a fall of more than 30 was recorded by eight after vaccine compared with none after placebo (binomial test p=0008). However, when participants with colds were excluded, there was no significant difference in the numbers with falls of more than 20 between vaccine and placebo (six vs three; binomial test p=051), although the difference for PEF decreases of more than 30 approached significance (five vs none; binomial test, p=006). This association was confined to first-time vaccinees.Interpretation Our findings indicate that pulmonary-function abnormalities may occur as a complication of influenza vaccination. However, the risk of pulmonary complications is very small and outweighed by the benefits of vaccination.
Url:
DOI: 10.1016/S0140-6736(97)07468-0
Affiliations:
- Royaume-Uni
- Angleterre, Grand Londres, Grand Manchester, Midlands de l'Ouest
- Birmingham, Londres, Manchester
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Nicholson</name><affiliation><wicri:noCountry code="subField">Leicester</wicri:noCountry></affiliation></author><author><name sortKey="Nguyen Van Tam, Jonathan S" sort="Nguyen Van Tam, Jonathan S" uniqKey="Nguyen Van Tam J" first="Jonathan S" last="Nguyen-Van-Tam">Jonathan S. Nguyen-Van-Tam</name><affiliation><wicri:noCountry code="subField">Nottingham</wicri:noCountry></affiliation></author><author><name sortKey="Ahmed, Ala Eldin H" sort="Ahmed, Ala Eldin H" uniqKey="Ahmed A" first="Ala'Eldin H" last="Ahmed">Ala'Eldin H. Ahmed</name><affiliation><wicri:noCountry code="subField">Leicester</wicri:noCountry></affiliation></author><author><name sortKey="Wiselka, Martin J" sort="Wiselka, Martin J" uniqKey="Wiselka M" first="Martin J" last="Wiselka">Martin J. Wiselka</name><affiliation><wicri:noCountry code="subField">Leicester</wicri:noCountry></affiliation></author><author><name sortKey="Leese, Jane" sort="Leese, Jane" uniqKey="Leese J" first="Jane" last="Leese">Jane Leese</name><affiliation wicri:level="3"><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName><wicri:orgArea>Department of Health</wicri:orgArea></affiliation></author><author><name sortKey="Ayres, Jon" sort="Ayres, Jon" uniqKey="Ayres J" first="Jon" last="Ayres">Jon Ayres</name><affiliation wicri:level="3"><country>Royaume-Uni</country><placeName><settlement type="city">Birmingham</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Midlands de l'Ouest</region></placeName><wicri:orgArea>Department of Respiratory Medicine, Birmingham Heartlands Hospital</wicri:orgArea></affiliation></author><author><name sortKey="Campbell, James H" sort="Campbell, James H" uniqKey="Campbell J" first="James H" last="Campbell">James H. 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Hutchcroft</name><affiliation><wicri:noCountry code="subField">Sheffield</wicri:noCountry></affiliation></author><author><name sortKey="Pearson, James Cg" sort="Pearson, James Cg" uniqKey="Pearson J" first="James Cg" last="Pearson">James Cg Pearson</name><affiliation><wicri:noCountry code="subField">Nottingham</wicri:noCountry></affiliation></author><author><name sortKey="Willey, Richard F" sort="Willey, Richard F" uniqKey="Willey R" first="Richard F" last="Willey">Richard F. Willey</name><affiliation><wicri:noCountry code="subField">Lancaster</wicri:noCountry></affiliation></author><author><name sortKey="Wolstenholme, Roger J" sort="Wolstenholme, Roger J" uniqKey="Wolstenholme R" first="Roger J" last="Wolstenholme">Roger J. Wolstenholme</name><affiliation><wicri:noCountry code="subField">Wigan</wicri:noCountry></affiliation></author><author><name sortKey="Woodhead, Mark A" sort="Woodhead, Mark A" uniqKey="Woodhead M" first="Mark A" last="Woodhead">Mark A. Woodhead</name><affiliation wicri:level="3"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Manchester Royal Infirmary, Manchester</wicri:regionArea><placeName><settlement type="city">Manchester</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Manchester</region></placeName></affiliation></author></analytic><monogr></monogr><series><title level="j">The Lancet</title><title level="j" type="abbrev">LANCET</title><idno type="ISSN">0140-6736</idno><imprint><publisher>ELSEVIER</publisher><date type="published" when="1998">1998</date><biblScope unit="volume">351</biblScope><biblScope unit="issue">9099</biblScope><biblScope unit="page" from="326">326</biblScope><biblScope unit="page" to="331">331</biblScope></imprint><idno type="ISSN">0140-6736</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0140-6736</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="Teeft" xml:lang="en"><term>Allergic rhinitis</term><term>Annual vaccination</term><term>Antibiotic</term><term>Asthma</term><term>Asthma exacerbation</term><term>Asthma exacerbations</term><term>Asthmatic</term><term>Asthmatic children</term><term>Background rate</term><term>Baseline</term><term>Baseline characteristics</term><term>Binomial test</term><term>Categorical data</term><term>Chronic asthma</term><term>Clinical investigators</term><term>Crossover</term><term>Crossover design</term><term>Daily activities</term><term>District hospital</term><term>Exacerbation</term><term>Excess mortality</term><term>Family practitioners</term><term>Febrile illness</term><term>First injection</term><term>Hospital admission</term><term>Hospital admissions</term><term>Infectious diseases</term><term>Infirmary</term><term>Influenza</term><term>Influenza vaccination</term><term>Influenza vaccine</term><term>Influenza virus</term><term>Influenza viruses</term><term>Inhaled</term><term>Injection</term><term>Lancet</term><term>Medical consultations</term><term>Medication</term><term>Methacholine sensitivity</term><term>None binomial test</term><term>Oral steroids</term><term>Other studies</term><term>Participant</term><term>Personal reasons</term><term>Placebo</term><term>Placebo test</term><term>Positive events</term><term>Possible order effects</term><term>Previous studies</term><term>Prince philip hospital</term><term>Pulmonary function</term><term>Respiratory symptoms</term><term>Royal albert edward infirmary</term><term>Second injection</term><term>Severe exacerbation</term><term>Significant difference</term><term>Significant differences</term><term>Significant test</term><term>Small numbers</term><term>Smoking status</term><term>Sputum colour</term><term>Sputum production</term><term>Substantial morbidity</term><term>Symptom</term><term>Symptom score</term><term>Symptomatic colds</term><term>Tropical medicine</term><term>Unstable asthma</term><term>Vaccination</term><term>Vaccine</term><term>Vaccine development</term><term>Vaccinee</term><term>Wilcoxon test</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Summary: Background Despite current recommendations, many people with asthma do not receive annual vaccination against influenza, partly because of concern that vaccine may trigger exacerbations. Colds can trigger exacerbations, which may be mistaken for vaccine-related adverse events. We undertook a double-blind placebo-controlled multicentre crossover study to assess the safety of influenza vaccine in patients with asthma, with allowance for the occurrence of colds.Methods We studied 262 patients, aged 1875 years, who recorded daily peak expiratory flow (PEF), respiratory symptoms, medication, medical consultations, and hospital admissions for 2 weeks before the first injection and until 2 weeks after the second injection. Order of injection (vaccine and placebo) was assigned randomly. There was an interval of 2 weeks between injections. The main outcome measure was an exacerbation of asthma within 72 h of injection (defined as a fall in PEF of >20).Findings Among 255 participants with paired data, 11 recorded a fall in PEF of more than 20 after vaccine compared with three after placebo (McNemar's test p=006); a fall of more than 30 was recorded by eight after vaccine compared with none after placebo (binomial test p=0008). However, when participants with colds were excluded, there was no significant difference in the numbers with falls of more than 20 between vaccine and placebo (six vs three; binomial test p=051), although the difference for PEF decreases of more than 30 approached significance (five vs none; binomial test, p=006). This association was confined to first-time vaccinees.Interpretation Our findings indicate that pulmonary-function abnormalities may occur as a complication of influenza vaccination. However, the risk of pulmonary complications is very small and outweighed by the benefits of vaccination.</div></front></TEI><affiliations><list><country><li>Royaume-Uni</li></country><region><li>Angleterre</li><li>Grand Londres</li><li>Grand Manchester</li><li>Midlands de l'Ouest</li></region><settlement><li>Birmingham</li><li>Londres</li><li>Manchester</li></settlement></list><tree><noCountry><name sortKey="Ahmed, Ala Eldin H" sort="Ahmed, Ala Eldin H" uniqKey="Ahmed A" first="Ala'Eldin H" last="Ahmed">Ala'Eldin H. Ahmed</name><name sortKey="Campbell, James H" sort="Campbell, James H" uniqKey="Campbell J" first="James H" last="Campbell">James H. Campbell</name><name sortKey="Ebden, Philip" sort="Ebden, Philip" uniqKey="Ebden P" first="Philip" last="Ebden">Philip Ebden</name><name sortKey="Hutchcroft, Bruce J" sort="Hutchcroft, Bruce J" uniqKey="Hutchcroft B" first="Bruce J" last="Hutchcroft">Bruce J. Hutchcroft</name><name sortKey="Nguyen Van Tam, Jonathan S" sort="Nguyen Van Tam, Jonathan S" uniqKey="Nguyen Van Tam J" first="Jonathan S" last="Nguyen-Van-Tam">Jonathan S. Nguyen-Van-Tam</name><name sortKey="Nicholson, Karl G" sort="Nicholson, Karl G" uniqKey="Nicholson K" first="Karl G" last="Nicholson">Karl G. Nicholson</name><name sortKey="Pearson, James Cg" sort="Pearson, James Cg" uniqKey="Pearson J" first="James Cg" last="Pearson">James Cg Pearson</name><name sortKey="Willey, Richard F" sort="Willey, Richard F" uniqKey="Willey R" first="Richard F" last="Willey">Richard F. Willey</name><name sortKey="Wiselka, Martin J" sort="Wiselka, Martin J" uniqKey="Wiselka M" first="Martin J" last="Wiselka">Martin J. Wiselka</name><name sortKey="Wolstenholme, Roger J" sort="Wolstenholme, Roger J" uniqKey="Wolstenholme R" first="Roger J" last="Wolstenholme">Roger J. Wolstenholme</name></noCountry><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Leese, Jane" sort="Leese, Jane" uniqKey="Leese J" first="Jane" last="Leese">Jane Leese</name></region><name sortKey="Ayres, Jon" sort="Ayres, Jon" uniqKey="Ayres J" first="Jon" last="Ayres">Jon Ayres</name><name sortKey="Eiser, Noemi M" sort="Eiser, Noemi M" uniqKey="Eiser N" first="Noemi M" last="Eiser">Noemi M. Eiser</name><name sortKey="Woodhead, Mark A" sort="Woodhead, Mark A" uniqKey="Woodhead M" first="Mark A" last="Woodhead">Mark A. Woodhead</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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