Study Results
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Basic Information
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COMPLETED
117 participants
OBSERVATIONAL
2018-08-09
2021-08-10
Brief Summary
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Detailed Description
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Any form of tobacco use, especially cigarette smoking, plays an important role in this disease. Asthmatic smokers are prone to several negative outcomes. Cigarette smoking by itself is associated with airway inflammation and features of airway remodelling including increased epithelial proliferation, squamous cell metaplasia, goblet cell hyperplasia, smooth muscle hypertrophy, and increases in bronchial glands mass.
Corticosteroid insensitivity is an important clinical feature of asthma, particularly in patients with severe disease and smokers. The mechanisms of corticosteroid insensitivity in asthmatic patients are poorly understood.
One of the major problems in the treatment of smoking asthma patients is the lack of efficacy data in this group of patients as smokers have almost always been excluded from studies on asthma due to perceived concerns about recruiting patients with COPD. Therefore, there is a lack of specific information about the treatment of asthma in smokers. The asthmatic smoker is a special phenotype with important therapeutic and prognostic clinical implications.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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smoker asthmatics
* Asthma control questionnaire (ACQ) score
* Spirometry
* Sputum cytology
using serum periostin and eotaxin-2 level
collect serum sample from each group and detection of serum periostin and eotaxin-2 are using Eliza kits.
each group is divided into two groups (patients who are already using ICS and patients who do not use ICS) and we compare between to groups in airway hypersensitivity.
airway corticosteroid sensitivity
each group is divided into two groups (patients who are already using inhaled corticosteroid ICS and patients who do not use ICS) and we compare between to groups in airway hypersensitivity.
non-smoker asthmatics
* Asthma control questionnaire (ACQ) score
* Spirometry
* Sputum cytology
using serum periostin and eotaxin-2 level
collect serum sample from each group and detection of serum periostin and eotaxin-2 are using Eliza kits.
each group is divided into two groups (patients who are already using ICS and patients who do not use ICS) and we compare between to groups in airway hypersensitivity.
airway corticosteroid sensitivity
each group is divided into two groups (patients who are already using inhaled corticosteroid ICS and patients who do not use ICS) and we compare between to groups in airway hypersensitivity.
Interventions
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using serum periostin and eotaxin-2 level
collect serum sample from each group and detection of serum periostin and eotaxin-2 are using Eliza kits.
each group is divided into two groups (patients who are already using ICS and patients who do not use ICS) and we compare between to groups in airway hypersensitivity.
airway corticosteroid sensitivity
each group is divided into two groups (patients who are already using inhaled corticosteroid ICS and patients who do not use ICS) and we compare between to groups in airway hypersensitivity.
Eligibility Criteria
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Inclusion Criteria
2. Treatment with long-acting b2-agonists, and leukotriene receptor antagonists was allowed.
Exclusion Criteria
2. Causes of airway obstruction other than asthma as COPD patients, bronchiectasis……etc.
3. Age \<18 and \>45 years old.
4. Body mass index \>35.
5. Requirement for treatment with or the presence of conditions likely to be exacerbated by oral corticosteroids
6. The intention to stop smoking. Eligibility for the study required demonstration of reversible airflow obstruction (FEV1 bronchodilator response to b2 agonist of \>12% \[and \>200 mL\]) or a positive methacholine test result. All lung function assessments met relevant international consensus guidelines.
18 Years
45 Years
MALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Safaa Abd El-gayed Eid
principal investigator
Principal Investigators
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Safaa A Eid, master
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Locations
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Assuit University Hospital
Asyut, , Egypt
Countries
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References
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James AL, Palmer LJ, Kicic E, Maxwell PS, Lagan SE, Ryan GF, Musk AW. Decline in lung function in the Busselton Health Study: the effects of asthma and cigarette smoking. Am J Respir Crit Care Med. 2005 Jan 15;171(2):109-14. doi: 10.1164/rccm.200402-230OC. Epub 2004 Oct 14.
Lange P, Scharling H, Ulrik CS, Vestbo J. Inhaled corticosteroids and decline of lung function in community residents with asthma. Thorax. 2006 Feb;61(2):100-4. doi: 10.1136/thx.2004.037978.
O'Byrne PM, Lamm CJ, Busse WW, Tan WC, Pedersen S; START Investigators Group. The effects of inhaled budesonide on lung function in smokers and nonsmokers with mild persistent asthma. Chest. 2009 Dec;136(6):1514-1520. doi: 10.1378/chest.09-1049. Epub 2009 Aug 26.
Tamimi A, Serdarevic D, Hanania NA. The effects of cigarette smoke on airway inflammation in asthma and COPD: therapeutic implications. Respir Med. 2012 Mar;106(3):319-28. doi: 10.1016/j.rmed.2011.11.003. Epub 2011 Dec 22.
Chatkin JM, Dullius CR. The management of asthmatic smokers. Asthma Res Pract. 2016 Jun 20;2:10. doi: 10.1186/s40733-016-0025-7. eCollection 2016.
Hiroshima K, Iyoda A, Shibuya K, Hoshino H, Haga Y, Toyozaki T, Shiba M, Baba M, Fujisawa T, Ohwada H. Evidence of neoangiogenesis and an increase in the number of proliferating cells within the bronchial epithelium of smokers. Cancer. 2002 Oct 1;95(7):1539-45. doi: 10.1002/cncr.10850.
Mathe G, Santelli G, Gouveia J, Lemaigre G, Misset JL, Gros F, Homasson JP, Kim B, Sudre MC, Gaget H. Correlation of bronchial epidermoid metaplasia with level of tobacco consumption in heavy smokers. Cancer Detect Prev. 1986;9(1-2):79-81.
Niewoehner DE, Kleinerman J, Rice DB. Pathologic changes in the peripheral airways of young cigarette smokers. N Engl J Med. 1974 Oct 10;291(15):755-8. doi: 10.1056/NEJM197410102911503. No abstract available.
Cosio MG, Hale KA, Niewoehner DE. Morphologic and morphometric effects of prolonged cigarette smoking on the small airways. Am Rev Respir Dis. 1980 Aug;122(2):265-21. doi: 10.1164/arrd.1980.122.2.265.
McSharry C, Spears M, Chaudhuri R, Cameron EJ, Husi H, Thomson NC. Increased sputum endotoxin levels are associated with an impaired lung function response to oral steroids in asthmatic patients. J Allergy Clin Immunol. 2014 Nov;134(5):1068-75. doi: 10.1016/j.jaci.2014.08.022. Epub 2014 Sep 26.
Decramer M, Louis R, Joos G, De Vuyst P, Mast B, Mehuys A; Pulmonary Advisory Board. (Ex-)smoking asthma patients in general and specialized Belgian practice. Respir Med. 2011 Aug;105(8):1203-10. doi: 10.1016/j.rmed.2011.02.017. Epub 2011 Mar 16.
Vozoris NT, Stanbrook MB. Smoking prevalence, behaviours, and cessation among individuals with COPD or asthma. Respir Med. 2011 Mar;105(3):477-84. doi: 10.1016/j.rmed.2010.08.011. Epub 2010 Sep 17.
Cerveri I, Cazzoletti L, Corsico AG, Marcon A, Niniano R, Grosso A, Ronzoni V, Accordini S, Janson C, Pin I, Siroux V, de Marco R. The impact of cigarette smoking on asthma: a population-based international cohort study. Int Arch Allergy Immunol. 2012;158(2):175-83. doi: 10.1159/000330900. Epub 2012 Jan 26.
Chaudhuri R, McSharry C, McCoard A, Livingston E, Hothersall E, Spears M, Lafferty J, Thomson NC. Role of symptoms and lung function in determining asthma control in smokers with asthma. Allergy. 2008 Jan;63(1):132-5. doi: 10.1111/j.1398-9995.2007.01538.x.
Clatworthy J, Price D, Ryan D, Haughney J, Horne R. The value of self-report assessment of adherence, rhinitis and smoking in relation to asthma control. Prim Care Respir J. 2009 Dec;18(4):300-5. doi: 10.4104/pcrj.2009.00037.
Chalmers GW, Macleod KJ, Little SA, Thomson LJ, McSharry CP, Thomson NC. Influence of cigarette smoking on inhaled corticosteroid treatment in mild asthma. Thorax. 2002 Mar;57(3):226-30. doi: 10.1136/thorax.57.3.226.
Lazarus SC, Chinchilli VM, Rollings NJ, Boushey HA, Cherniack R, Craig TJ, Deykin A, DiMango E, Fish JE, Ford JG, Israel E, Kiley J, Kraft M, Lemanske RF Jr, Leone FT, Martin RJ, Pesola GR, Peters SP, Sorkness CA, Szefler SJ, Wechsler ME, Fahy JV; National Heart Lung and Blood Institute's Asthma Clinical Research Network. Smoking affects response to inhaled corticosteroids or leukotriene receptor antagonists in asthma. Am J Respir Crit Care Med. 2007 Apr 15;175(8):783-90. doi: 10.1164/rccm.200511-1746OC. Epub 2007 Jan 4.
Other Identifiers
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IBBAAS
Identifier Type: -
Identifier Source: org_study_id
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