Bronchial AsthmaNCT03207620
Interrelation Between Bronchial Asthma and Smoking
An observational study of Bronchial Asthma, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- using serum periostin and eotaxin-2 level and airway corticosteroid sensitivity
- How many people
- 117 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Aug 2018to 10 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bronchial Asthma
- Being tested
- using serum periostin and eotaxin-2 level, airway corticosteroid sensitivity
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| smoker asthmatics | * Asthma control questionnaire (ACQ) score
* Spirometry
* Sputum cytology Receives: Diagnostic Test: using serum periostin and eotaxin-2 level; Diagnostic Test: airway corticosteroid sensitivity | |
| non-smoker asthmatics | * Asthma control questionnaire (ACQ) score
* Spirometry
* Sputum cytology Receives: Diagnostic Test: using serum periostin and eotaxin-2 level; Diagnostic Test: airway corticosteroid sensitivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum periostin
detect its level in serum
Measured: one day
Serum eotaxin-2
detect its level in serum
Measured: One day
Secondary outcomes (3)
Spirometry
pre- and post bronchodilator FEV1 will be measured.
Measured: one day
Sputum cytology
detect proportion of eosinophils and neutrophils in sputum cytology.
Measured: one day
airway corticosteroid sensitivity
Airway corticosteroid sensitivity will be assessed by change in pre-bronchodilator FEV1 (forced expiratory volume at one second) .
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start9 Aug 2018
- Primary completion1 Aug 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Abd El-gayed Eid, Assiut University
- Investigators
- Safaa A Eid, master, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207620
- Sponsor's protocol ID
- IBBAAS
- Status last verified
- Jan 2022
- First submitted
- 27 Jun 2017
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20850288Cerveri 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.
PubMed 22286571Chaudhuri 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.
PubMed 18053022Clatworthy 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.
PubMed 19562233Chalmers 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.
PubMed 11867826Lazarus 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.
PubMed 17204725James 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.
PubMed 15486340Lange 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.
PubMed 16443705O'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.
PubMed 19710291Tamimi 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.
PubMed 22196881Chatkin 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.
PubMed 27965778Hiroshima 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.
PubMed 12237923Mathe 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.
PubMed 3731197Niewoehner 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.
PubMed 4414996Cosio 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.
PubMed 7416603
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrelation Between Bronchial Asthma and Smoking
- ClinicalTrials.gov ID
- NCT03207620
- Acronym / sponsor ID
- IBBAAS
- Conditions
- Bronchial Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smoker asthmatics | – | Diagnostic Test: using serum periostin and eotaxin-2 level, Diagnostic Test: airway corticosteroid sensitivity* Asthma control questionnaire (ACQ) score * Spirometry * Sputum cytology |
| non-smoker asthmatics | – | Diagnostic Test: using serum periostin and eotaxin-2 level, Diagnostic Test: airway corticosteroid sensitivity* Asthma control questionnaire (ACQ) score * Spirometry * Sputum cytology |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| using serum periostin and eotaxin-2 levelcollect 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 | non-smoker asthmatics, smoker asthmatics |
| airway corticosteroid sensitivityeach 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. | Diagnostic test | non-smoker asthmatics, smoker asthmatics |
Primary outcome
serum periostin
Time frame: one day
detect its level in serum
Serum eotaxin-2
Time frame: One day
detect its level in serum
3 secondary outcomes
Spirometry
Time frame: one day
Sputum cytology
Time frame: one day
airway corticosteroid sensitivity
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 20850288Vozoris 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.
- Background: PubMed 22286571Cerveri 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.
- Background: PubMed 18053022Chaudhuri 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.
- Background: PubMed 19562233Clatworthy 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.
- Background: PubMed 11867826Chalmers 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.
- Background: PubMed 17204725Lazarus 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.
- Background: PubMed 15486340James 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.
- Background: PubMed 16443705Lange 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.
- Background: PubMed 19710291O'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.
- Background: PubMed 22196881Tamimi 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.
- Background: PubMed 27965778Chatkin 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.
- Background: PubMed 12237923Hiroshima 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safaa A Eid, master principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum periostin (time frame: one day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03207620, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.