Interrelation Between Bronchial Asthma and Smoking

Completed

• Conditions: Bronchial Asthma
• Interventions: Diagnostic Test: using serum periostin and eotaxin-2 level; Diagnostic Test: airway corticosteroid sensitivity

• Registration Number: NCT03207620
• Lead Sponsor: Assiut University

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-05
• Study Start: 2018-08-09
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-10
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 117

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-smoker asthmatics	using serum periostin and eotaxin-2 level	* Asthma control questionnaire (ACQ) score * Spirometry * Sputum cytology
non-smoker asthmatics	airway corticosteroid sensitivity	* Asthma control questionnaire (ACQ) score * Spirometry * Sputum cytology
smoker asthmatics	using serum periostin and eotaxin-2 level	* Asthma control questionnaire (ACQ) score * Spirometry * Sputum cytology
smoker asthmatics	airway corticosteroid sensitivity	* Asthma control questionnaire (ACQ) score * Spirometry * Sputum cytology

Primary Outcome Measures

Name	Time	Method
serum periostin	one day	detect its level in serum
Serum eotaxin-2	One day	detect its level in serum

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assuit University Hospital; 🇪🇬 Assiut, Egypt