Interrelation Between Bronchial Asthma and Smoking

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03207620
Collaborator
(none)
117
1
36
3.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: using serum periostin and eotaxin-2 level
  • Diagnostic Test: airway corticosteroid sensitivity

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.

Study Design

Study Type:
Observational
Actual Enrollment :
117 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Interrelation Between Bronchial Asthma and Smoking
Actual Study Start Date :
Aug 9, 2018
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
Aug 10, 2021

Arms and Interventions

Arm Intervention/Treatment
smoker asthmatics

Asthma control questionnaire (ACQ) score Spirometry Sputum cytology

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.

Diagnostic Test: 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

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.

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

  1. serum periostin [one day]

    detect its level in serum

  2. Serum eotaxin-2 [One day]

    detect its level in serum

Secondary Outcome Measures

  1. Spirometry [one day]

    pre- and post bronchodilator FEV1 will be measured.

  2. Sputum cytology [one day]

    detect proportion of eosinophils and neutrophils in sputum cytology.

  3. airway corticosteroid sensitivity [one month]

    Airway corticosteroid sensitivity will be assessed by change in pre-bronchodilator FEV1 (forced expiratory volume at one second) .

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assuit University Hospital Assiut Egypt Assiut university 71515

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Safaa A Eid, master, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Safaa Abd El-gayed Eid, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03207620
Other Study ID Numbers:
  • IBBAAS
First Posted:
Jul 5, 2017
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022