Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control

Asthma Clinical Trial

— PRIPASCO  

Official title:

Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286007
• Other study ID #: PRIPASCO-2023
• Status: Recruiting
• Start date: December 21, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: February 2024
• Source: Hospital Clinico Universitario de Santiago
• Contact: Francisco-Javier GONZALEZ BARCALA, MD, PhD
• Phone: +34607819141
• Email: francisco.javier.gonzalez.barcala[@]sergas.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The main objective is to estimate the annual symptomatic incidence of Bordetella pertussis and RSV infections in patients aged 18 years and over with asthma, which will be identified by PCR, for Bordetella pertussis and by PCR for RSV performed at a specific timepoint from onset of symptoms for each symptomatic Acute Respiratory Infection (ARI). A multicentre prospective cohort study will be undertaken in Spain. Thirty-five centres from different autonomous communities in Spain will participate in the study. Participants will be asked to report to the investigator if they experience an asthma exacerbation or symptoms of acute respiratory infection with 2 years follow up

Description:

The main objective is to estimate the annual symptomatic incidence of Bordetella pertussis and RSV infections in patients aged 18 years and over with asthma, which will be identified by PCR, for Bordetella pertussis and by PCR for RSV performed at a specific timepoint from onset of symptoms for each symptomatic Acute Respiratory Infection (ARI). A multicentre prospective cohort study will be undertaken in Spain. Thirty-five centres from different autonomous communities in Spain will participate in the study. Participants will be asked to report to the investigator if they experience an asthma exacerbation or symptoms of acute respiratory infection with 2 years follow up Depending on the symptoms presented and date of symptom onset, For pertussis, patients will undergo a nasopharyngeal swab specimen for PCR if onset of the symptoms was within the past 3 weeks For RSV, patients will undergo a nasopharyngeal swab specimen for PCR if onset of the symptoms was within the past 72 hours.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 784
• Est. completion date: July 1, 2026
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adult patient (age 18 years and over)
• Diagnosed with asthma at least one year prior to the date of enrolment.
• Patients who, in the opinion of the investigator, can and will comply with the requirements of the study protocol for the duration of the follow-up period (e.g. agree to provide samples for testing, able to attend for testing upon asthma exacerbation and/or ARI symptoms occurring)
• Patients who are able to provide written informed consent.

Exclusion Criteria:

• Patients with a prior history of pertussis in the last 12 months
• Patients with ARI within the 2 weeks prior to enrolment
• Patients who have another respiratory disease other than asthma, alcohol or drug abuse at the time of being included in the study, or an active oncological disease (patients in treatment or follow-up for oncological disease) or pregnant women.
• Patients treated with immunosuppressive or immunomodulating agents not related to asthma diagnosis. will be excluded.
• Patients vaccinated for RSV will be also excluded (NOTE: -Patients that have received an RSV (investigational) vaccine or medicine for any of the above, should be excluded from the study from the beginning. Patients that might be vaccinated in the upcoming years, while the study is still ongoing, can enrol. However, from the moment they receive a vaccine, they should be excluded and no additional data will be collected. Data collected during the study up until the time of vaccination will still be included in the analysis).
• Patients vaccinated for B. Pertussis during the previous 12 months will be also excluded.
• Patients who plan to move during the study period will be excluded.

Related Conditions & MeSH terms

• Asthma
• Pertussis
• Respiratory Syncytial Virus Infections
• RSV Infection
• Whooping Cough

Intervention

Diagnostic Test:
• PCR
Depending on the symptoms presented and date of symptom onset, for pertussis, patients will undergo a nasopharyngeal swab specimen for PCR if onset of the symptoms was within the past 3 weeks For RSV, patients will undergo a nasopharyngeal swab specimen for PCR if onset of the symptoms was within the past 72 hours.

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago De Compostela	A Coruña

Sponsors (32)

Lead Sponsor

Collaborator

Hospital Clinico Universitario de Santiago

CIBER of Respiratory Diseases CIBERES, Complexo Hospitalario Universitario de A Coruña, Consortium for Biomedical Research in Epidemiology and Public Health, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Germans Trias i Pujol Hospital, Hospital Clinic of Barcelona, Hospital Clinico Universitario San Cecilio, Hospital Clínico Universitario Virgen de la Arrixaca, Hospital Costa del Sol, Hospital de Galdakao, Hospital de La Princesa, Hospital de Sagunto, Hospital del Mar, Hospital El Bierzo, Hospital General Universitario Dr. Balmis, Hospital Lluis Alcanyís de Xàtiva, Hospital San Pedro de Alcantara, Hospital Universitario Central de Asturias, Hospital Universitario de Jerez de la Frontera, Hospital Universitario de la Ribera, Hospital Universitario de Navarra, Hospital Universitario Doctor Peset, Hospital Universitario Donostia, Hospital Universitario Lucus Augusti, Hospital Universitario Marqués de Valdecilla, Hospital Universitario Vall d´Hebron, Hospital Universitario Virgen del Rocio, Translational Research In Airway Diseases Group (TRIAD), Universidade de Santiago de Compostela, Universitat Autonoma de Barcelona, University Hospital Virgen de las Nieves

Country where clinical trial is conducted

Spain, 

References & Publications (71)

Abu-Raya B, Maertens K, Edwards KM, Omer SB, Englund JA, Flanagan KL, Snape MD, Amirthalingam G, Leuridan E, Damme PV, Papaevangelou V, Launay O, Dagan R, Campins M, Cavaliere AF, Frusca T, Guidi S, O'Ryan M, Heininger U, Tan T, Alsuwaidi AR, Safadi MA, Vilca LM, Wanlapakorn N, Madhi SA, Giles ML, Prymula R, Ladhani S, Martinon-Torres F, Tan L, Michelin L, Scambia G, Principi N, Esposito S. Global Perspectives on Immunization During Pregnancy and Priorities for Future Research and Development: An International Consensus Statement. Front Immunol. 2020 Jun 24;11:1282. doi: 10.3389/fimmu.2020.01282. eCollection 2020. — View Citation

Aris E, Harrington L, Bhavsar A, Simeone JC, Ramond A, Papi A, Vogelmeier CF, Meszaros K, Lambrelli D, Mukherjee P. Burden of Pertussis in COPD: A Retrospective Database Study in England. COPD. 2021 Apr;18(2):157-169. doi: 10.1080/15412555.2021.1899155. Epub 2021 Apr 19. — View Citation

Beasley R, Coleman ED, Hermon Y, Holst PE, O'Donnell TV, Tobias M. Viral respiratory tract infection and exacerbations of asthma in adult patients. Thorax. 1988 Sep;43(9):679-83. doi: 10.1136/thx.43.9.679. — View Citation

Bianchini S, Silvestri E, Argentiero A, Fainardi V, Pisi G, Esposito S. Role of Respiratory Syncytial Virus in Pediatric Pneumonia. Microorganisms. 2020 Dec 21;8(12):2048. doi: 10.3390/microorganisms8122048. — View Citation

Bjornsson E, Hjelm E, Janson C, Fridell E, Boman G. Serology of respiratory viruses in relation to asthma and bronchial hyperresponsiveness. Ups J Med Sci. 1996;101(2):159-68. doi: 10.3109/03009739609178920. — View Citation

Brugueras S, Rius C, Millet JP, Casals M, Cayla JA; Barcelona Pertussis Working Group. Does the economic recession influence the incidence of pertussis in a cosmopolitan European city? BMC Public Health. 2019 Feb 4;19(1):144. doi: 10.1186/s12889-019-6448-3. — View Citation

Buck PO, Meyers JL, Gordon LD, Parikh R, Kurosky SK, Davis KL. Economic burden of diagnosed pertussis among individuals with asthma or chronic obstructive pulmonary disease in the USA: an analysis of administrative claims. Epidemiol Infect. 2017 Jul;145(10):2109-2121. doi: 10.1017/S0950268817000887. Epub 2017 May 2. — View Citation

Campins M, Moreno-Perez D, Gil-de Miguel A, Gonzalez-Romo F, Moraga-Llop FA, Aristegui-Fernandez J, Gonce-Mellgren A, Bayas JM, Salleras-Sanmarti L. [Whooping cough in Spain. Current epidemiology, prevention and control strategies. Recommendations by the Pertussis Working Group]. Enferm Infecc Microbiol Clin. 2013 Apr;31(4):240-53. doi: 10.1016/j.eimc.2012.12.011. Epub 2013 Feb 12. Spanish. — View Citation

Capili CR, Hettinger A, Rigelman-Hedberg N, Fink L, Boyce T, Lahr B, Juhn YJ. Increased risk of pertussis in patients with asthma. J Allergy Clin Immunol. 2012 Apr;129(4):957-63. doi: 10.1016/j.jaci.2011.11.020. Epub 2011 Dec 28. — View Citation

Cilloniz C, Pericas JM, Rojas JR, Torres A. Severe Infections Due to Respiratory Viruses. Semin Respir Crit Care Med. 2022 Feb;43(1):60-74. doi: 10.1055/s-0041-1740982. Epub 2022 Feb 16. — View Citation

Coyle AJ, Erard F, Bertrand C, Walti S, Pircher H, Le Gros G. Virus-specific CD8+ cells can switch to interleukin 5 production and induce airway eosinophilia. J Exp Med. 1995 Mar 1;181(3):1229-33. doi: 10.1084/jem.181.3.1229. — View Citation

Dafauce L, Romero D, Carpio C, Barga P, Quirce S, Villasante C, Bravo MF, Alvarez-Sala R. Psycho-demographic profile in severe asthma and effect of emotional mood disorders and hyperventilation syndrome on quality of life. BMC Psychol. 2021 Jan 6;9(1):3. doi: 10.1186/s40359-020-00498-y. — View Citation

De Serres G, Shadmani R, Duval B, Boulianne N, Dery P, Douville Fradet M, Rochette L, Halperin SA. Morbidity of pertussis in adolescents and adults. J Infect Dis. 2000 Jul;182(1):174-9. doi: 10.1086/315648. Epub 2000 Jun 30. — View Citation

Douville RN, Bastien N, Li Y, Simons FE, HayGlass KT. Adult asthmatics display exaggerated IFNgamma responses to human metapneumovirus and respiratory syncytial virus. Biochem Cell Biol. 2007 Apr;85(2):252-8. doi: 10.1139/O07-005. — View Citation

Falsey AR, Hennessey PA, Formica MA, Cox C, Walsh EE. Respiratory syncytial virus infection in elderly and high-risk adults. N Engl J Med. 2005 Apr 28;352(17):1749-59. doi: 10.1056/NEJMoa043951. — View Citation

Falsey AR, Walsh EE, Capellan J, Gravenstein S, Zambon M, Yau E, Gorse GJ, Edelman R, Hayden FG, McElhaney JE, Neuzil KM, Nichol KL, Simoes EA, Wright PF, Sales VM. Comparison of the safety and immunogenicity of 2 respiratory syncytial virus (rsv) vaccines--nonadjuvanted vaccine or vaccine adjuvanted with alum--given concomitantly with influenza vaccine to high-risk elderly individuals. J Infect Dis. 2008 Nov 1;198(9):1317-26. doi: 10.1086/592168. — View Citation

Falsey AR, Walsh EE, Esser MT, Shoemaker K, Yu L, Griffin MP. Respiratory syncytial virus-associated illness in adults with advanced chronic obstructive pulmonary disease and/or congestive heart failure. J Med Virol. 2019 Jan;91(1):65-71. doi: 10.1002/jmv.25285. Epub 2018 Sep 24. — View Citation

Feddema JJ, Claassen E. Prevalence of viral respiratory infections amongst asthmatics: Results of a meta-regression analysis. Respir Med. 2020 Nov;173:106020. doi: 10.1016/j.rmed.2020.106020. Epub 2020 May 15. — View Citation

Fleming DM, Taylor RJ, Lustig RL, Schuck-Paim C, Haguinet F, Webb DJ, Logie J, Matias G, Taylor S. Modelling estimates of the burden of Respiratory Syncytial virus infection in adults and the elderly in the United Kingdom. BMC Infect Dis. 2015 Oct 23;15:443. doi: 10.1186/s12879-015-1218-z. — View Citation

Galan I, Rodriguez-Artalejo F, Tobias A, Diez-Ganan L, Gandarillas A, Zorrilla B. Clustering of behavior-related risk factors and its association with subjective health. Gac Sanit. 2005 Sep-Oct;19(5):370-8. doi: 10.1157/13080135. — View Citation

GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9. Erratum In: Lancet. 2020 Nov 14;396(10262):1562. — View Citation

Gehlhar K, Bilitewski C, Reinitz-Rademacher K, Rohde G, Bufe A. Impaired virus-induced interferon-alpha2 release in adult asthmatic patients. Clin Exp Allergy. 2006 Mar;36(3):331-7. doi: 10.1111/j.1365-2222.2006.02450.x. — View Citation

Griffin MR, Coffey CS, Neuzil KM, Mitchel EF Jr, Wright PF, Edwards KM. Winter viruses: influenza- and respiratory syncytial virus-related morbidity in chronic lung disease. Arch Intern Med. 2002 Jun 10;162(11):1229-36. doi: 10.1001/archinte.162.11.1229. — View Citation

Grissell TV, Powell H, Shafren DR, Boyle MJ, Hensley MJ, Jones PD, Whitehead BF, Gibson PG. Interleukin-10 gene expression in acute virus-induced asthma. Am J Respir Crit Care Med. 2005 Aug 15;172(4):433-9. doi: 10.1164/rccm.200412-1621OC. Epub 2005 May 13. — View Citation

Guiso N, Gallais JL, Gavazzi G, Pinquier D, Gaillat J. Incidence of pertussis in subjects aged 50years and older in France in 2013-2014. Med Mal Infect. 2018 Feb;48(1):30-36. doi: 10.1016/j.medmal.2017.09.002. Epub 2017 Oct 13. — View Citation

Hancock GE, Scheuer CA, Sierzega R, Pryharski KS, McBride JT, Watelet LF, Tebbey PW, Smith JD. Adaptive immune responses of patients with asthma to the attachment (G) glycoprotein of respiratory synctial virus. J Infect Dis. 2001 Dec 15;184(12):1589-93. doi: 10.1086/324583. — View Citation

Harju TH, Leinonen M, Nokso-Koivisto J, Korhonen T, Raty R, He Q, Hovi T, Mertsola J, Bloigu A, Rytila P, Saikku P. Pathogenic bacteria and viruses in induced sputum or pharyngeal secretions of adults with stable asthma. Thorax. 2006 Jul;61(7):579-84. doi: 10.1136/thx.2005.056291. Epub 2006 Mar 3. — View Citation

Hirose H, Matsuse H, Tsuchida T, Fukahori S, Fukushima C, Mizuta Y, Kohno S. Cytokine production from peripheral blood mononuclear cells of mite allergen-sensitized atopic adults stimulated with respiratory syncytial virus and mite allergen. Int Arch Allergy Immunol. 2008;146(2):149-55. doi: 10.1159/000113518. Epub 2008 Jan 18. — View Citation

Jenkins VA, Savic M, Kandeil W. Pertussis in high-risk groups: an overview of the past quarter-century. Hum Vaccin Immunother. 2020 Nov 1;16(11):2609-2617. doi: 10.1080/21645515.2020.1738168. Epub 2020 Apr 16. — View Citation

Johnson TR, Parker RA, Johnson JE, Graham BS. IL-13 is sufficient for respiratory syncytial virus G glycoprotein-induced eosinophilia after respiratory syncytial virus challenge. J Immunol. 2003 Feb 15;170(4):2037-45. doi: 10.4049/jimmunol.170.4.2037. — View Citation

Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J. 1999 Jul;14(1):32-8. doi: 10.1034/j.1399-3003.1999.14a08.x. — View Citation

Kandeil W, Atanasov P, Avramioti D, Fu J, Demarteau N, Li X. The burden of pertussis in older adults: what is the role of vaccination? A systematic literature review. Expert Rev Vaccines. 2019 May;18(5):439-455. doi: 10.1080/14760584.2019.1588727. Epub 2019 Mar 25. — View Citation

Langsam D, Anis E, Haas EJ, Gosinov R, Yechezkel M, Grotto I, Shmueli E, Yamin D. Tdap vaccination during pregnancy interrupts a twenty-year increase in the incidence of pertussis. Vaccine. 2020 Mar 10;38(12):2700-2706. doi: 10.1016/j.vaccine.2020.01.095. Epub 2020 Feb 15. — View Citation

Lee N, Lui GC, Wong KT, Li TC, Tse EC, Chan JY, Yu J, Wong SS, Choi KW, Wong RY, Ngai KL, Hui DS, Chan PK. High morbidity and mortality in adults hospitalized for respiratory syncytial virus infections. Clin Infect Dis. 2013 Oct;57(8):1069-77. doi: 10.1093/cid/cit471. Epub 2013 Jul 21. — View Citation

Leong RNF, Wood JG, Liu B, McIntyre PB, Newall AT. High healthcare resource utilisation due to pertussis in Australian adults aged 65 years and over. Vaccine. 2020 Apr 23;38(19):3553-3559. doi: 10.1016/j.vaccine.2020.03.021. Epub 2020 Mar 24. — View Citation

Liu BC, McIntyre P, Kaldor JM, Quinn HE, Ridda I, Banks E. Pertussis in older adults: prospective study of risk factors and morbidity. Clin Infect Dis. 2012 Dec;55(11):1450-6. doi: 10.1093/cid/cis627. Epub 2012 Jul 17. — View Citation

Loubet P, Voiriot G, Houhou-Fidouh N, Neuville M, Bouadma L, Lescure FX, Descamps D, Timsit JF, Yazdanpanah Y, Visseaux B. Impact of respiratory viruses in hospital-acquired pneumonia in the intensive care unit: A single-center retrospective study. J Clin Virol. 2017 Jun;91:52-57. doi: 10.1016/j.jcv.2017.04.001. Epub 2017 Apr 22. — View Citation

Lukacs NW, Tekkanat KK, Berlin A, Hogaboam CM, Miller A, Evanoff H, Lincoln P, Maassab H. Respiratory syncytial virus predisposes mice to augmented allergic airway responses via IL-13-mediated mechanisms. J Immunol. 2001 Jul 15;167(2):1060-5. doi: 10.4049/jimmunol.167.2.1060. Erratum In: J Immunol. 2005 Dec 15;175(12):8442. — View Citation

Luyt CE. Virus diseases in ICU patients: a long time underestimated; but be aware of overestimation. Intensive Care Med. 2006 Jul;32(7):968-70. doi: 10.1007/s00134-006-0203-9. Epub 2006 May 24. No abstract available. — View Citation

Marchi S, Montomoli E, Remarque EJ, Monteverde Spencer GT, Azzarello A, Viviani S, Trombetta CM. Pertussis over two decades: seroepidemiological study in a large population of the Siena Province, Tuscany Region, Central Italy. BMJ Open. 2019 Oct 30;9(10):e032987. doi: 10.1136/bmjopen-2019-032987. — View Citation

Martini H, Rodeghiero C, VAN DEN Poel C, Vincent M, Pierard D, Huygen K. Pertussis diagnosis in Belgium: results of the National Reference Centre for Bordetella anno 2015. Epidemiol Infect. 2017 Aug;145(11):2366-2373. doi: 10.1017/S0950268817001108. Epub 2017 Jun 5. — View Citation

Martinon-Torres F, Heininger U, Thomson A, Wirsing von Konig CH. Controlling pertussis: how can we do it? A focus on immunization. Expert Rev Vaccines. 2018 Apr;17(4):289-297. doi: 10.1080/14760584.2018.1445530. Epub 2018 Mar 12. — View Citation

Martinón-Torres F. Expected and Unexpected Effects of Vaccination. In: Vesikari T, Van Damme P, editors. Pediatric Vaccines and Vaccinations, Cham (Switzerland): 2017, p. 3-13

Matsumoto K, Inoue H. Viral infections in asthma and COPD. Respir Investig. 2014 Mar;52(2):92-100. doi: 10.1016/j.resinv.2013.08.005. Epub 2013 Sep 27. — View Citation

Mbayei SA, Faulkner A, Miner C, Edge K, Cruz V, Pena SA, Kudish K, Coleman J, Pradhan E, Thomas S, Martin S, Skoff TH. Severe Pertussis Infections in the United States, 2011-2015. Clin Infect Dis. 2019 Jul 2;69(2):218-226. doi: 10.1093/cid/ciy889. — View Citation

McDonald KL, Huq SI, Lix LM, Becker AB, Kozyrskyj AL. Delay in diphtheria, pertussis, tetanus vaccination is associated with a reduced risk of childhood asthma. J Allergy Clin Immunol. 2008 Mar;121(3):626-31. doi: 10.1016/j.jaci.2007.11.034. Epub 2008 Jan 18. — View Citation

McKeever TM, Lewis SA, Smith C, Hubbard R. Vaccination and allergic disease: a birth cohort study. Am J Public Health. 2004 Jun;94(6):985-9. doi: 10.2105/ajph.94.6.985. — View Citation

McLaughlin JM, Khan F, Begier E, Swerdlow DL, Jodar L, Falsey AR. Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis. Open Forum Infect Dis. 2022 Jun 17;9(7):ofac300. doi: 10.1093/ofid/ofac300. eCollection 2022 Jul. — View Citation

Miyashita N, Akaike H, Teranishi H, Kawai Y, Ouchi K, Kato T, Hayashi T, Okimoto N. Diagnostic value of symptoms and laboratory data for pertussis in adolescent and adult patients. BMC Infect Dis. 2013 Mar 11;13:129. doi: 10.1186/1471-2334-13-129. — View Citation

Nagel G, Weinmayr G, Flohr C, Kleiner A, Strachan DP; ISAAC Phase Two Study Group. Association of pertussis and measles infections and immunizations with asthma and allergic sensitization in ISAAC Phase Two. Pediatr Allergy Immunol. 2012 Dec;23(8):737-46. doi: 10.1111/pai.12007. Epub 2012 Sep 24. — View Citation

O'Sullivan S, Cormican L, Faul JL, Ichinohe S, Johnston SL, Burke CM, Poulter LW. Activated, cytotoxic CD8(+) T lymphocytes contribute to the pathology of asthma death. Am J Respir Crit Care Med. 2001 Aug 15;164(4):560-4. doi: 10.1164/ajrccm.164.4.2102018. — View Citation

Pneumonia Etiology Research for Child Health (PERCH) Study Group. Causes of severe pneumonia requiring hospital admission in children without HIV infection from Africa and Asia: the PERCH multi-country case-control study. Lancet. 2019 Aug 31;394(10200):757-779. doi: 10.1016/S0140-6736(19)30721-4. Epub 2019 Jun 27. Erratum In: Lancet. 2019 Aug 31;394(10200):736. — View Citation

Randi BA, Sejas ONE, Miyaji KT, Infante V, Lara AN, Ibrahim KY, Lopes MH, Sartori AMC. A systematic review of adult tetanus-diphtheria-acellular (Tdap) coverage among healthcare workers. Vaccine. 2019 Feb 14;37(8):1030-1037. doi: 10.1016/j.vaccine.2018.12.046. Epub 2019 Jan 7. — View Citation

Redondo E, Rivero-Calle I, Mascaros E, Yuste JE, Fernandez-Prada M, Ocana D, Jimeno I, Gil A, Molina J, Diaz-Maroto JL, Linares M, Martinon-Torres F; en nombre de Neumoexpertos en Prevencion. [Vaccination against community acquired pneumonia in adults. Update 2021 of the position paper by Neumoexpertos en Prevencion Group]. Semergen. 2021 Sep;47(6):411-425. doi: 10.1016/j.semerg.2021.06.005. Epub 2021 Jul 29. Spanish. — View Citation

Ristic M, Radosavljevic B, Stojanovic VD, Dilas M, Petrovic V. Performance of the new clinical case definitions of pertussis in pertussis suspected infection and other diagnoses similar to pertussis. PLoS One. 2018 Sep 20;13(9):e0204103. doi: 10.1371/journal.pone.0204103. eCollection 2018. — View Citation

Rubin K, Glazer S. The pertussis hypothesis: Bordetella pertussis colonization in the etiology of asthma and diseases of allergic sensitization. Med Hypotheses. 2018 Nov;120:101-115. doi: 10.1016/j.mehy.2018.08.006. Epub 2018 Aug 10. — View Citation

Schlaud M, Schmitz R, Poethko-Muller C, Kuhnert R. Vaccinations in the first year of life and risk of atopic disease - Results from the KiGGS study. Vaccine. 2017 Sep 12;35(38):5156-5162. doi: 10.1016/j.vaccine.2017.07.111. Epub 2017 Aug 8. — View Citation

Sigurs N, Gustafsson PM, Bjarnason R, Lundberg F, Schmidt S, Sigurbergsson F, Kjellman B. Severe respiratory syncytial virus bronchiolitis in infancy and asthma and allergy at age 13. Am J Respir Crit Care Med. 2005 Jan 15;171(2):137-41. doi: 10.1164/rccm.200406-730OC. Epub 2004 Oct 29. — View Citation

Stein RT, Sherrill D, Morgan WJ, Holberg CJ, Halonen M, Taussig LM, Wright AL, Martinez FD. Respiratory syncytial virus in early life and risk of wheeze and allergy by age 13 years. Lancet. 1999 Aug 14;354(9178):541-5. doi: 10.1016/S0140-6736(98)10321-5. — View Citation

Sundaram ME, Meece JK, Sifakis F, Gasser RA Jr, Belongia EA. Medically attended respiratory syncytial virus infections in adults aged >/= 50 years: clinical characteristics and outcomes. Clin Infect Dis. 2014 Feb;58(3):342-9. doi: 10.1093/cid/cit767. Epub 2013 Nov 21. — View Citation

van Scott MR, Justice JP, Bradfield JF, Enright E, Sigounas A, Sur S. IL-10 reduces Th2 cytokine production and eosinophilia but augments airway reactivity in allergic mice. Am J Physiol Lung Cell Mol Physiol. 2000 Apr;278(4):L667-74. doi: 10.1152/ajplung.2000.278.4.L667. — View Citation

Vega JM, Badia X, Badiola C, Lopez-Vina A, Olaguibel JM, Picado C, Sastre J, Dal-Re R; Covalair Investigator Group. Validation of the Spanish version of the Asthma Control Test (ACT). J Asthma. 2007 Dec;44(10):867-72. doi: 10.1080/02770900701752615. — View Citation

Vogt H, Braback L, Kling AM, Grunewald M, Nilsson L. Pertussis immunization in infancy and adolescent asthma medication. Pediatrics. 2014 Oct;134(4):721-8. doi: 10.1542/peds.2014-0723. Epub 2014 Sep 22. — View Citation

Walsh EE. Respiratory Syncytial Virus Infection: An Illness for All Ages. Clin Chest Med. 2017 Mar;38(1):29-36. doi: 10.1016/j.ccm.2016.11.010. Epub 2016 Dec 27. — View Citation

Weinberger R, Riffelmann M, Kennerknecht N, Hulsse C, Littmann M, O'Brien J, von Kries R, von Konig CHW. Long-lasting cough in an adult German population: incidence, symptoms, and related pathogens. Eur J Clin Microbiol Infect Dis. 2018 Apr;37(4):665-672. doi: 10.1007/s10096-017-3158-6. Epub 2018 Jan 4. — View Citation

Westerly BD, Peebles RS Jr. Respiratory syncytial virus infections in the adult asthmatic--mechanisms of host susceptibility and viral subversion. Immunol Allergy Clin North Am. 2010 Nov;30(4):523-39, vi-vii. doi: 10.1016/j.iac.2010.08.006. Epub 2010 Sep 22. — View Citation

Widmer K, Griffin MR, Zhu Y, Williams JV, Talbot HK. Respiratory syncytial virus- and human metapneumovirus-associated emergency department and hospital burden in adults. Influenza Other Respir Viruses. 2014 May;8(3):347-52. doi: 10.1111/irv.12234. Epub 2014 Feb 7. — View Citation

Wilkinson TMA, Van den Steen P, Cheuvart B, Baudson N, Dodet M, Turriani E, Harrington L, Meyer N, Rondini S, Taddei L, Mukherjee P. Seroprevalence of Bordetella pertussis Infection in Patients With Chronic Obstructive Pulmonary Disease in England: Analysis of the AERIS Cohort. COPD. 2021 Jun;18(3):341-348. doi: 10.1080/15412555.2021.1920904. Epub 2021 May 6. — View Citation

Zambon MC, Stockton JD, Clewley JP, Fleming DM. Contribution of influenza and respiratory syncytial virus to community cases of influenza-like illness: an observational study. Lancet. 2001 Oct 27;358(9291):1410-6. doi: 10.1016/s0140-6736(01)06528-x. — View Citation

Zeevat F, Luttjeboer J, Paulissen JHJ, van der Schans J, Beutels P, Boersma C, Postma MJ; RESCEU Investigators. Exploratory Analysis of the Economically Justifiable Price of a Hypothetical RSV Vaccine for Older Adults in the Netherlands and the United Kingdom. J Infect Dis. 2022 Aug 12;226(Suppl 1):S102-S109. doi: 10.1093/infdis/jiab118. — View Citation

Zhang Y, Sakthivel SK, Bramley A, Jain S, Haynes A, Chappell JD, Hymas W, Lenny N, Patel A, Qi C, Ampofo K, Arnold SR, Self WH, Williams DJ, Hillyard D, Anderson EJ, Grijalva CG, Zhu Y, Wunderink RG, Edwards KM, Pavia AT, McCullers JA, Erdman DD. Serology Enhances Molecular Diagnosis of Respiratory Virus Infections Other than Influenza in Children and Adults Hospitalized with Community-Acquired Pneumonia. J Clin Microbiol. 2016 Dec 28;55(1):79-89. doi: 10.1128/JCM.01701-16. Print 2017 Jan. — View Citation

* Note: There are 71 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Bordetella pertussis and RSV infections in adult patients with asthma,	Incidence of Bordetella pertussis and RSV infections in adult patients with asthma,using PCR test	2 years
Secondary	To describe the seroprevalence of Bordetella pertussis in adult patients with asthma	To describe the seroprevalence of Bordetella pertussis in adult patients aged with asthma, at the time of inclusion, at 12 months, and at the end of two years follow-up, in all the patients that are still included in the study, using serological test	2 years
Secondary	To describe the seroprevalence of RSV in adult patients with asthma	To describe the seroprevalence RSV in adult patients with asthma, at the time of inclusion, at 12 months, and at the end of two years follow-up, in all the patients that are still included in the study, using serological test	2 years
Secondary	To evaluate the severity and control of the asthma caused by either BP or RSV infection	To evaluate, on an annual basis, the severity and control of the asthma, with regards to acute laboratory-confirmed respiratory illness caused by either BP or RSV infection during the study, using Asthma Control Test (ACT) questionnaire	2 years

External Links

•   2022
•   Access in June 2021
•   Access in June 2021
•   Access in June 2021
•   Access in June 2021
•   Access in June 2021
•   June 2022