NCT03207620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 9, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

3 years

First QC Date

June 27, 2017

Last Update Submit

January 6, 2022

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (2)

  • serum periostin

    detect its level in serum

    one day

  • Serum eotaxin-2

    detect its level in serum

    One day

Secondary Outcomes (3)

  • Spirometry

    one day

  • Sputum cytology

    one day

  • airway corticosteroid sensitivity

    one month

Study Arms (2)

smoker asthmatics

* Asthma control questionnaire (ACQ) score * Spirometry * Sputum cytology

Diagnostic Test: using serum periostin and eotaxin-2 levelDiagnostic Test: airway corticosteroid sensitivity

non-smoker asthmatics

* Asthma control questionnaire (ACQ) score * Spirometry * Sputum cytology

Diagnostic Test: using serum periostin and eotaxin-2 levelDiagnostic Test: airway corticosteroid sensitivity

Interventions

using serum periostin and eotaxin-2 levelDIAGNOSTIC_TEST

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.

non-smoker asthmaticssmoker asthmatics
airway corticosteroid sensitivityDIAGNOSTIC_TEST

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 asthmaticssmoker asthmatics

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit University Hospital

Asyut, Assiut university 71515, Egypt

Location

Related Publications (17)

  • Vozoris NT, Stanbrook MB. Smoking prevalence, behaviours, and cessation among individuals with COPD or asthma. Respir Med. 2011 Mar;105(3):477-84. doi: 10.1016/j.rmed.2010.08.011. Epub 2010 Sep 17.

    PMID: 20850288BACKGROUND

  • Cerveri I, Cazzoletti L, Corsico AG, Marcon A, Niniano R, Grosso A, Ronzoni V, Accordini S, Janson C, Pin I, Siroux V, de Marco R. The impact of cigarette smoking on asthma: a population-based international cohort study. Int Arch Allergy Immunol. 2012;158(2):175-83. doi: 10.1159/000330900. Epub 2012 Jan 26.

    PMID: 22286571BACKGROUND

  • Chaudhuri R, McSharry C, McCoard A, Livingston E, Hothersall E, Spears M, Lafferty J, Thomson NC. Role of symptoms and lung function in determining asthma control in smokers with asthma. Allergy. 2008 Jan;63(1):132-5. doi: 10.1111/j.1398-9995.2007.01538.x.

    PMID: 18053022BACKGROUND

  • Clatworthy J, Price D, Ryan D, Haughney J, Horne R. The value of self-report assessment of adherence, rhinitis and smoking in relation to asthma control. Prim Care Respir J. 2009 Dec;18(4):300-5. doi: 10.4104/pcrj.2009.00037.

    PMID: 19562233BACKGROUND

  • Chalmers GW, Macleod KJ, Little SA, Thomson LJ, McSharry CP, Thomson NC. Influence of cigarette smoking on inhaled corticosteroid treatment in mild asthma. Thorax. 2002 Mar;57(3):226-30. doi: 10.1136/thorax.57.3.226.

    PMID: 11867826BACKGROUND

  • Lazarus SC, Chinchilli VM, Rollings NJ, Boushey HA, Cherniack R, Craig TJ, Deykin A, DiMango E, Fish JE, Ford JG, Israel E, Kiley J, Kraft M, Lemanske RF Jr, Leone FT, Martin RJ, Pesola GR, Peters SP, Sorkness CA, Szefler SJ, Wechsler ME, Fahy JV; National Heart Lung and Blood Institute's Asthma Clinical Research Network. Smoking affects response to inhaled corticosteroids or leukotriene receptor antagonists in asthma. Am J Respir Crit Care Med. 2007 Apr 15;175(8):783-90. doi: 10.1164/rccm.200511-1746OC. Epub 2007 Jan 4.

    PMID: 17204725BACKGROUND

  • James AL, Palmer LJ, Kicic E, Maxwell PS, Lagan SE, Ryan GF, Musk AW. Decline in lung function in the Busselton Health Study: the effects of asthma and cigarette smoking. Am J Respir Crit Care Med. 2005 Jan 15;171(2):109-14. doi: 10.1164/rccm.200402-230OC. Epub 2004 Oct 14.

    PMID: 15486340BACKGROUND

  • Lange P, Scharling H, Ulrik CS, Vestbo J. Inhaled corticosteroids and decline of lung function in community residents with asthma. Thorax. 2006 Feb;61(2):100-4. doi: 10.1136/thx.2004.037978.

    PMID: 16443705BACKGROUND

  • O'Byrne PM, Lamm CJ, Busse WW, Tan WC, Pedersen S; START Investigators Group. The effects of inhaled budesonide on lung function in smokers and nonsmokers with mild persistent asthma. Chest. 2009 Dec;136(6):1514-1520. doi: 10.1378/chest.09-1049. Epub 2009 Aug 26.

    PMID: 19710291BACKGROUND

  • Tamimi A, Serdarevic D, Hanania NA. The effects of cigarette smoke on airway inflammation in asthma and COPD: therapeutic implications. Respir Med. 2012 Mar;106(3):319-28. doi: 10.1016/j.rmed.2011.11.003. Epub 2011 Dec 22.

    PMID: 22196881BACKGROUND

  • Chatkin JM, Dullius CR. The management of asthmatic smokers. Asthma Res Pract. 2016 Jun 20;2:10. doi: 10.1186/s40733-016-0025-7. eCollection 2016.

    PMID: 27965778BACKGROUND

  • Hiroshima K, Iyoda A, Shibuya K, Hoshino H, Haga Y, Toyozaki T, Shiba M, Baba M, Fujisawa T, Ohwada H. Evidence of neoangiogenesis and an increase in the number of proliferating cells within the bronchial epithelium of smokers. Cancer. 2002 Oct 1;95(7):1539-45. doi: 10.1002/cncr.10850.

    PMID: 12237923BACKGROUND

  • Mathe G, Santelli G, Gouveia J, Lemaigre G, Misset JL, Gros F, Homasson JP, Kim B, Sudre MC, Gaget H. Correlation of bronchial epidermoid metaplasia with level of tobacco consumption in heavy smokers. Cancer Detect Prev. 1986;9(1-2):79-81.

    PMID: 3731197BACKGROUND

  • Niewoehner DE, Kleinerman J, Rice DB. Pathologic changes in the peripheral airways of young cigarette smokers. N Engl J Med. 1974 Oct 10;291(15):755-8. doi: 10.1056/NEJM197410102911503. No abstract available.

    PMID: 4414996BACKGROUND

  • Cosio MG, Hale KA, Niewoehner DE. Morphologic and morphometric effects of prolonged cigarette smoking on the small airways. Am Rev Respir Dis. 1980 Aug;122(2):265-21. doi: 10.1164/arrd.1980.122.2.265.

    PMID: 7416603BACKGROUND

  • McSharry C, Spears M, Chaudhuri R, Cameron EJ, Husi H, Thomson NC. Increased sputum endotoxin levels are associated with an impaired lung function response to oral steroids in asthmatic patients. J Allergy Clin Immunol. 2014 Nov;134(5):1068-75. doi: 10.1016/j.jaci.2014.08.022. Epub 2014 Sep 26.

    PMID: 25262463BACKGROUND

  • Decramer M, Louis R, Joos G, De Vuyst P, Mast B, Mehuys A; Pulmonary Advisory Board. (Ex-)smoking asthma patients in general and specialized Belgian practice. Respir Med. 2011 Aug;105(8):1203-10. doi: 10.1016/j.rmed.2011.02.017. Epub 2011 Mar 16.

    PMID: 21414762BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

sputum and serum sample

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Safaa A Eid, master

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 27, 2017

First Posted

July 5, 2017

Study Start

August 9, 2018

Primary Completion

August 1, 2021

Study Completion

August 10, 2021

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)