AsthmaESMAANCT02153411
Multicentric, Transversal, Descriptive, Epidemiological Study on the Management of Asthma in Asthmatic Middle East Adult Population
An observational study of Asthma, run by AstraZeneca at 98 sites in 11 countries.
Trial summary
Descriptive study on the management of asthma in asthmatic Middle East adult population : Algeria,Egypt, Irak,Iran, Jordan, Koweit, Lebanon, Qatar,Saudi,Tunisia, UAE Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Asthma
- How many people
- 7,294 participants
- Where
- 98 sitesin 11 countries
- Study dates
- Jun 2014to Dec 2015
- 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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asthmatic since at least one year before inclusion. Patient's informed consent obtained.
Who may be able to join
- Men and women, 18 years of age and older. Asthmatic since at least one year before inclusion. Patient's informed consent obtained.
Who cannot join
- Patient concurrently participating to another study. Patient with concomitant pulmonary disease. Patient with psychiatric disorders. Patient consulting for an asthma attack
Trial locations and contacts
98 sites in 11 countries.
98 sites in 11 countries
Algeria37 sites
Research Site
Aïn Beïda, Nis-rme-xxx-2014/1
Research Site
Ain Naadja, Nis-rme-xxx-2014/1
Research Site
Algiers, Nis-rme-xxx-2014/1
Research Site
Annaba, Nis-rme-xxx-2014/1
Research Site
Azzaba, Nis-rme-xxx-2014/1
Research Site
Bāb al-Wādī, Nis-rme-xxx-2014/1
Research Site
Bab Ezzouar, Nis-rme-xxx-2014/1
Research Site
Babez, Nis-rme-xxx-2014/1
Research Site
Batna City, Nis-rme-xxx-2014/1
Research Site
Béjaïa, Nis-rme-xxx-2014/1
Research Site
Birkhadem, Nis-rme-xxx-2014/1
Research Site
Blida, Nis-rme-xxx-2014/1
Research Site
Bordj Bou Arreridj, Nis-rme-xxx-2014/1
Research Site
Bordj Menail, Nis-rme-xxx-2014/1
Research Site
Bouïra, Nis-rme-xxx-2014/1
Research Site
Bouzarea, Nis-rme-xxx-2014/1
Research Site
Constantine, Nis-rme-xxx-2014/1
Research Site
El Eulma, Nis-rme-xxx-2014/1
Research Site
Essania, Nis-rme-xxx-2014/1
Research Site
Gouraya, Nis-rme-xxx-2014/1
Research Site
Lakhdaria, Nis-rme-xxx-2014/1
Research Site
Larbaâ, Nis-rme-xxx-2014/1
Research Site
M'Sila, Nis-rme-xxx-2014/1
Research Site
Mascara, Nis-rme-xxx-2014/1
Research Site
Meftah, Nis-rme-xxx-2014/1
Research Site
Mila, Nis-rme-xxx-2014/1
Research Site
Misserghin, Nis-rme-xxx-2014/1
Research Site
Mostaghanem, Nis-rme-xxx-2014/1
Research Site
Oran, Nis-rme-xxx-2014/1
Research Site
Ouled Beni Messous, Nis-rme-xxx-2014/1
Research Site
Rouiba, Nis-rme-xxx-2014/1
Research Site
Sétif, Nis-rme-xxx-2014/1
Research Site
Sidi Bel Abbes, Nis-rme-xxx-2014/1
Research Site
Tiaret, Nis-rme-xxx-2014/1
Research Site
Tipasa, Nis-rme-xxx-2014/1
Research Site
Tizi Ouzou, Nis-rme-xxx-2014/1
Research Site
Zeralda, Nis-rme-xxx-2014/1
Egypt11 sites
Research Site
Alexandria, Nis-rme-xxx-2014/1
Research Site
Cairo, Nis-rme-xxx-2014/1
Research Site
Domyat - Delta, Nis-rme-xxx-2014/1
Research Site
Giza - Cairo, Nis-rme-xxx-2014/1
Research Site
Ismalia - Delta, Nis-rme-xxx-2014/1
Research Site
Mansoura - Delta, Nis-rme-xxx-2014/1
Research Site
Menofia - Delta, Nis-rme-xxx-2014/1
Research Site
Menoufia - Delta, Nis-rme-xxx-2014/1
Research Site
Portsaid - Delta, Nis-rme-xxx-2014/1
Research Site
Tanta - Delta, Nis-rme-xxx-2014/1
Research Site
Zagazig - Delta, Nis-rme-xxx-2014/1
Iran11 sites
Research Site
Ahvāz, Nis-rme-xxx-2014/1
Research Site
Isfahan, Nis-rme-xxx-2014/1
Research Site
Karaj, Nis-rme-xxx-2014/1
Research Site
Kerman, Nis-rme-xxx-2014/1
Research Site
Mashhad, Nis-rme-xxx-2014/1
Research Site
Rasht, Nis-rme-xxx-2014/1
Research Site
Sari, Nis-rme-xxx-2014/1
Research Site
Shiraz, Nis-rme-xxx-2014/1
Research Site
Tabriz, Nis-rme-xxx-2014/1
Research Site
Tehran, Nis-rme-xxx-2014/1
Research Site
Yazd, Nis-rme-xxx-2014/1
Lebanon10 sites
Research Site
Bkaa, Nis-rme-xxx-2014/1
Research Site
Chweifat, Nis-rme-xxx-2014/1
Research Site
Dahieh, Nis-rme-xxx-2014/1
Research Site
East Beirut, Nis-rme-xxx-2014/1
Research Site
Keserwen, Nis-rme-xxx-2014/1
Research Site
Maten, Nis-rme-xxx-2014/1
Research Site
North Beirut, Nis-rme-xxx-2014/1
Research Site
South Beirut, Nis-rme-xxx-2014/1
Research Site
South Metn, Nis-rme-xxx-2014/1
Research Site
West Beirut, Nis-rme-xxx-2014/1
Iraq7 sites
Research Site
Baghdad, Nis-rme-xxx-2014/1
Research Site
Basra, Nis-rme-xxx-2014/1
Research Site
Erbil, Nis-rme-xxx-2014/1
Research Site
Hillah, Nis-rme-xxx-2014/1
Research Site
Manşūrīyah, Nis-rme-xxx-2014/1
Research Site
Najaf, Nis-rme-xxx-2014/1
Research Site
Sulaimania, Nis-rme-xxx-2014/1
Jordan6 sites
Research Site
Amman, Nis-rme-xxx-2014/1
Research Site
Irbid, Nis-rme-xxx-2014/1
Research Site
Madaba, Nis-rme-xxx-2014/1
Research Site
Russeifa, Nis-rme-xxx-2014/1
Research Site
Salt, Nis-rme-xxx-2014/1
Research Site
Zarqa, Nis-rme-xxx-2014/1
Saudi Arabia5 sites
Research Site
Al Hadā, Nis-rme-xxx-2014/1
Research Site
Dammam, Nis-rme-xxx-2014/1
Research Site
Jeddah, Nis-rme-xxx-2014/1
Research Site
Khobar, Nis-rme-xxx-2014/1
Research Site
Riyadh, Nis-rme-xxx-2014/1
United Arab Emirates4 sites
Research Site
Abu Dhabi, Nis-rme-xxx-2014/1
Research Site
Al Ain City, Nis-rme-xxx-2014/1
Research Site
Dubai, Nis-rme-xxx-2014/1
Research Site
Sharjah city, Nis-rme-xxx-2014/1
Kuwait3 sites
Research Site
Kuwait City, Nis-rme-xxx-2014/1
Research Site
Kuwait City, Nis-rme-xxx-2014/2
Research Site
Kuwait City, Nis-rme-xxx-2014/5
Tunisia3 sites
Research Site
Sfax, Nis-rme-xxx-2014/1
Research Site
Sousse, Nis-rme-xxx-2014/1
Research Site
Tunis, Nis-rme-xxx-2014/1
About this study
Official title: Evaluation of aSthma Management in Middle EAst Adult Population
Descriptive study on the management of asthma in asthmatic Middle East adult population : Algeria,Egypt, Irak,Iran, Jordan, Koweit, Lebanon, Qatar,Saudi,Tunisia, UAE
Read the detailed description
Multicentric, transversal, descriptive, epidemiological study, conducted in a random sample of general practitioner and medical specialist (Pulmonologist and/or allergologist) in the public and the private sector.
- Conditions
- Asthma
- Keywords
- Asthma control
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 8645 asthmatic patients | Men and women, 18 years of age and older. Asthmatic since at least one year before inclusion. Patient's informed consent obtained. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control
Daytime symptoms Limitation of activities Nocturnal symptoms / awakening Need for reliever /rescue treatment Lung function (PEF or FEV)
Measured: Up to 1 year
Secondary outcomes (3)
general and sociodemographic patient's characteristics
sex, age, BMI, educational level, occupation, comorbidities, smoking status, and social security coverage.
Measured: up to 1 year
Identify predictive factors of asthma control,
such as age, sex, BMI, smoking status, adherence to treatment, asthma history, comorbidity.
Measured: UP to 1 year
asthma control level
Asthma control test questionnaire : activities at work,breathless,asthma symptoms (wheezing, coughing, chest tightness, shortness of breath;use of rescue inhaler or taken a nebulizer treatment ,asthma assessment
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 7,294 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153411
- Sponsor's protocol ID
- NIS-RME-XXX-2014/1
- Other IDs
- NIS-RME-XXX-2014/1
- Acronym
- ESMAA
- Status last verified
- Nov 2016
- First submitted
- 30 May 2014
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of aSthma Management in Middle EAst Adult Population
- ClinicalTrials.gov ID
- NCT02153411
- Acronym / sponsor ID
- ESMAA / NIS-RME-XXX-2014/1
- Conditions
- Asthma
- Keywords
- Asthma control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,294 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Jun 2014 (estimated)
- 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.
Descriptive study on the management of asthma in asthmatic Middle East adult population : Algeria,Egypt, Irak,Iran, Jordan, Koweit, Lebanon, Qatar,Saudi,Tunisia, UAE
Detailed description
Multicentric, transversal, descriptive, epidemiological study, conducted in a random sample of general practitioner and medical specialist (Pulmonologist and/or allergologist) in the public and the private sector.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 8645 asthmatic patients | – | –Men and women, 18 years of age and older. Asthmatic since at least one year before inclusion. Patient's informed consent obtained. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthmatic since at least one year before inclusion. Patient's informed consent obtained.
Key inclusion criteria (1 listed)
- Men and women, 18 years of age and older. Asthmatic since at least one year before inclusion. Patient's informed consent obtained.
Key exclusion criteria (1 listed)
- Patient concurrently participating to another study. Patient with concomitant pulmonary disease. Patient with psychiatric disorders. Patient consulting for an asthma attack
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asthma control
Time frame: Up to 1 year
Daytime symptoms Limitation of activities Nocturnal symptoms / awakening Need for reliever /rescue treatment Lung function (PEF or FEV)
3 secondary outcomes
general and sociodemographic patient's characteristics
Time frame: up to 1 year
Identify predictive factors of asthma control,
Time frame: UP to 1 year
asthma control level
Time frame: Up to 4 weeks
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 8 Nov 2016.
- CSR SynopsisLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
98 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 98 sites in 11 countries.
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 1 inclusion and 1 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in Algeria, Egypt, Iran, Lebanon, Iraq and 6 more countries. 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?
Asthma control (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2016.