Interrelation Between Bronchial Asthma and Smoking

Bronchial Asthma Clinical Trial

Official title:

Interrelation Between Bronchial Asthma and Smoking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207620
• Other study ID #: IBBAAS
• Status: Completed
• Start date: August 9, 2018
• Est. completion date: August 10, 2021

Study information

• Verified date: January 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Smoking occurs frequently in patients with asthma. Recent surveys on smoking prevalence report 21-26% current smokers in populations of patients with asthma. Detrimental effects of active smoking in asthma include worse asthma control, an impaired response to corticosteroids and accelerated lung function decline.

Description:

The mechanisms by which cigarette smoking contributes to disease severity in asthma are incompletely understood, but it has been suggested that cigarette smoking may change inflammation and airway remodelling in asthma to become more similar to that in COPD (chronic obstructive pulmonary disease).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: August 10, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria:

1. Stable asthmatic patients (however smokers, or non-smokers) will be included (stable asthmatic defined as no emergency clinic or hospital visit, oral corticosteroid prescription, or change in asthma treatment in the past month) and (Current smoking was defined as 5 or more cigarettes per day and a smoking history of 5 pack years or greater).

2. Treatment with long-acting b2-agonists, and leukotriene receptor antagonists was allowed.

Exclusion criteria:

1. Acute severe asthma.

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.

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Egypt	Assuit University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (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. — View Citation

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. — View Citation

Chatkin JM, Dullius CR. The management of asthmatic smokers. Asthma Res Pract. 2016 Jun 20;2:10. eCollection 2016. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2004 Oct 14. — View Citation

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. — View Citation

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. Epub 2007 Jan 4. — View Citation

Mathé 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum periostin	detect its level in serum	one day
Primary	Serum eotaxin-2	detect its level in serum	One day
Secondary	Spirometry	pre- and post bronchodilator FEV1 will be measured.	one day
Secondary	Sputum cytology	detect proportion of eosinophils and neutrophils in sputum cytology.	one day
Secondary	airway corticosteroid sensitivity	Airway corticosteroid sensitivity will be assessed by change in pre-bronchodilator FEV1 (forced expiratory volume at one second) .	one month