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Interrelation Between Bronchial Asthma and Smoking

Interrelation Between Bronchial Asthma and Smoking

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03207620
Enrollment
117
Registered
2017-07-05
Start date
2018-08-09
Completion date
2021-08-10
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Asthma

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.

Interventions

DIAGNOSTIC_TESTusing 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.

DIAGNOSTIC_TESTairway 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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
serum periostinone daydetect its level in serum
Serum eotaxin-2One daydetect its level in serum

Secondary

MeasureTime frameDescription
Spirometryone daypre- and post bronchodilator FEV1 will be measured.
Sputum cytologyone daydetect proportion of eosinophils and neutrophils in sputum cytology.
airway corticosteroid sensitivityone monthAirway corticosteroid sensitivity will be assessed by change in pre-bronchodilator FEV1 (forced expiratory volume at one second) .

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026