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Interrelation Between Bronchial Asthma and Smoking

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ClinicalTrials.gov Identifier: NCT03207620
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Safaa Abd El-gayed Eid, 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.

Condition or disease
Bronchial Asthma

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.


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Study Type : Observational
Estimated Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Interrelation Between Bronchial Asthma and Smoking
Actual Study Start Date : August 9, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Smoking

Group/Cohort
smoker asthmatics
  • Asthma control questionnaire (ACQ) score
  • Spirometry
  • Sputum cytology
  • Serum periostin and eotaxin-1 and eotaxin-2 level
  • Airway corticosteroid sensitivity
non-smoker asthmatics
  • Asthma control questionnaire (ACQ) score
  • Spirometry
  • Sputum cytology
  • Serum periostin and eotaxin-1 and eotaxin-2 level
  • Airway corticosteroid sensitivity



Primary Outcome Measures :
  1. serum periostin [ Time Frame: one day ]
    detect its level in serum

  2. Serum eotaxin [ Time Frame: One day ]
    detect its level in serum


Secondary Outcome Measures :
  1. Spirometry [ Time Frame: one day ]
    pre- and post bronchodilator FEV1 will be measured.

  2. Sputum cytology [ Time Frame: one day ]
    detect proportion of eosinophils and neutrophils in sputum cytology.

  3. airway corticosteroid sensitivity [ Time Frame: one month ]
    Airway corticosteroid sensitivity will be assessed by change in pre-bronchodilator FEV1 (forced expiratory volume at one second) .


Biospecimen Retention:   Samples With DNA
sputum and serum sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207620


Contacts
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Contact: Atef F Al-karn, MD 01006474200 afaroukeg@yahoo.com
Contact: Mohamed F Abd El-Ghany, MD 01006800525 mfawzy2013@hotmail.com

Locations
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Egypt
Assuit University Hospital Recruiting
Assiut, Egypt, Assiut university 71515
Contact: Safaa A Eid, master    01002569966    safaa_gayed@yahoo.com   
Contact: Atef F Al-karn, MD    01006474200    afaroukeg@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Safaa A Eid, master Assiut University

Publications:

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Responsible Party: Safaa Abd El-gayed Eid, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03207620     History of Changes
Other Study ID Numbers: IBBAAS
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases