Interrelation Between Bronchial Asthma and Smoking

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Interrelation Between Bronchial Asthma and Smoking

Conditions
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Bronchial Asthma

Intervention / Treatment
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* Diagnostic Test: using serum periostin and eotaxin-2 level
* Diagnostic Test: airway corticosteroid sensitivity


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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). Treatment with long-acting b2-agonists, and leukotriene receptor antagonists was allowed. Exclusion criteria: Acute severe asthma. Causes of airway obstruction other than asthma as COPD patients, bronchiectasis……etc. Age <18 and >45 years old. Body mass index >35. Requirement for treatment with or the presence of conditions likely to be exacerbated by oral corticosteroids 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| smoker asthmatics<br>Asthma control questionnaire (ACQ) score Spirometry Sputum cytology | Diagnostic Test: using serum periostin and eotaxin-2 level<br>* 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.<br>Diagnostic Test: airway corticosteroid sensitivity<br>* 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.<br>|
| non-smoker asthmatics<br>Asthma control questionnaire (ACQ) score Spirometry Sputum cytology | Diagnostic Test: using serum periostin and eotaxin-2 level<br>* 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.<br>Diagnostic Test: airway corticosteroid sensitivity<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum periostin | detect its level in serum | one day | 
| Serum eotaxin-2 | detect its level in serum | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry | pre- and post bronchodilator FEV1 will be measured. | one day | 
| Sputum cytology | detect proportion of eosinophils and neutrophils in sputum cytology. | one day | 
| airway corticosteroid sensitivity | Airway corticosteroid sensitivity will be assessed by change in pre-bronchodilator FEV1 (forced expiratory volume at one second) . | one month |