AsthmaNCT01741805
The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa
An observational study of Asthma, run by Carmel Medical Center at 1 site in Israel.
Trial summary
Asthma is a chronic illness characterized by inflammation of the airways. Severe asthma is defined in the literature as asthma not controlled by medication. In recent years it has become known that severe asthma is a variable disease and has subtypes relating to the age of onset, type of inflammation and allergy… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Asthma
- What is being tested?
- Severe Asthma
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2012to Apr 2014
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population of petients with severe asthma, described by presence of symptoms despite adequate treatment as described in the following sections.
Who may be able to join
- Presence of Asthma- typical symptoms and signs accompanied by either: a. obstruction in Spirometry, OR- b. positive methacholine test
- Regular use of high dose of inhaled corticosteroids (1000 micrograms of fluticasone per day or equivalent) in addition to a long acting beta agonist (LABA).
- Lack of asthma control- 2 or more exacerbations in the past year- exacerbations defined by hospitalization or care in an emergency department or treatment with systemic glucocorticosteroids for exacerbation of asthma symptoms.
Who cannot join
- Presence of another relevant respiratory illness, such as chronic obstructive pulmonary disease (COPD)
- lack of adherence to medical therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa.
Asthma is a chronic illness characterized by inflammation of the airways. Severe asthma is defined in the literature as asthma not controlled by medication. In recent years it has become known that severe asthma is a variable disease and has subtypes relating to the age of onset, type of inflammation and allergy, obesity, etc.
Our aim is to characterize the phenotypes of severe asthma population in our clinic and compare the prevalent phenotypes to the phenotypes described before.
Read the detailed description
Study measures will include the following:
- asthma demographic and symptoms questionnaire
- Validation of proper inhaler technique
- Height, weight measurements
- Forced spirometry and reversibility testing
- DLCO
- Fractional excretion of NO in exhaled breath
- Chest and sinus CT
- Induced sputum analysis
- Complete blood count, electrolytes, immunoglobulin E, Aspergillus Specific IgE
- Skin allergy testing
- Conditions
- Asthma
- Being tested
- Severe Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Severe AsthmaOther
Demographic data, Spirometry, induced sputum, IgE, Aspergillus specific IgE
| Study group | Role | What they receive |
|---|---|---|
| Severe Asthma | Patients with severe asthma as specified under inclusion, exclusion criteria Receives: Other: Severe Asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 second (FEV1)
Measured: 1 year
Secondary outcomes (6)
Carbon Monoxide Diffusion Capacity (DLCO)
Measured: 1 year
Percent eosinophils in induced sputum sample
Measured: 1 year
Bronchiectasis on computerized tomography (CT)
Measured: 1 year)
Blood level of Total immunoglobulin E (IgE)
Measured: 1 year
Presence of blood antibody to Aspergillus Fumigatus
Measured: 1 year
Fraction of Nitric Oxide (NO) in expired air
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionNov 2013
- Study completionApr 2014 (estimated)
Why it stopped: Slow recruitment of patients
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.
- 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michal Shteinberg, MD,PhD, Principal investigator, Pulmonology Institute, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741805
- Sponsor's protocol ID
- CMC-12-0032-CTIL
- Status last verified
- Jul 2016
- First submitted
- 2 Dec 2012
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa.
- ClinicalTrials.gov ID
- NCT01741805
- Acronym / sponsor ID
- CMC-12-0032-CTIL
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Slow recruitment of patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Apr 2014 (estimated)
- First posted
- 5 Dec 2012 (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.
Asthma is a chronic illness characterized by inflammation of the airways. Severe asthma is defined in the literature as asthma not controlled by medication. In recent years it has become known that severe asthma is a variable disease and has subtypes relating to the age of onset, type of inflammation and allergy, obesity, etc.
Our aim is to characterize the phenotypes of severe asthma population in our clinic and compare the prevalent phenotypes to the phenotypes described before.
Detailed description
Study measures will include the following:
- asthma demographic and symptoms questionnaire
- Validation of proper inhaler technique
- Height, weight measurements
- Forced spirometry and reversibility testing
- DLCO
- Fractional excretion of NO in exhaled breath
- Chest and sinus CT
- Induced sputum analysis
- Complete blood count, electrolytes, immunoglobulin E, Aspergillus Specific IgE
- Skin allergy testing
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Asthma | – | Other: Severe AsthmaPatients with severe asthma as specified under inclusion, exclusion criteria |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population of petients with severe asthma, described by presence of symptoms despite adequate treatment as described in the following sections.
Key inclusion criteria (3 listed)
- Presence of Asthma- typical symptoms and signs accompanied by either: a. obstruction in Spirometry, OR- b. positive methacholine test
- Regular use of high dose of inhaled corticosteroids (1000 micrograms of fluticasone per day or equivalent) in addition to a long acting beta agonist (LABA).
- Lack of asthma control- 2 or more exacerbations in the past year- exacerbations defined by hospitalization or care in an emergency department or treatment with systemic glucocorticosteroids for exacerbation of asthma symptoms.
Key exclusion criteria (2 listed)
- Presence of another relevant respiratory illness, such as chronic obstructive pulmonary disease (COPD)
- lack of adherence to medical therapy
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 |
|---|---|---|
| Severe AsthmaDemographic data, Spirometry, induced sputum, IgE, Aspergillus specific IgE | Other | Severe Asthma |
Primary outcome
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 1 year
6 secondary outcomes
Carbon Monoxide Diffusion Capacity (DLCO)
Time frame: 1 year
Percent eosinophils in induced sputum sample
Time frame: 1 year
Bronchiectasis on computerized tomography (CT)
Time frame: 1 year)
Blood level of Total immunoglobulin E (IgE)
Time frame: 1 year
Presence of blood antibody to Aspergillus Fumigatus
Time frame: 1 year
Fraction of Nitric Oxide (NO) in expired air
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- 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.
Michal Shteinberg, MD,PhD principal investigator
Pulmonology Institute, Carmel Medical Center
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 Asthma, run by Carmel Medical Center at 1 site in Israel.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 29 Jul 2016. 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 Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
Forced Expiratory Volume in 1 second (FEV1) (time frame: 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 29 Jul 2016.