AsthmaABI/BALANCT00615706
Study to Evaluate the Impact of Obesity on Airway Inflammation and Mechanics in Asthmatics
An observational study of Asthma, run by Emory University at 1 site in United States.
Trial summary
In the United States there has been a dramatic increase in the number of people who are obese and in the number of people who have asthma. Both are considered serious public health concerns. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Sep 2008
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Asthmatics and healthy volunteers
Who may be able to join
- Adults 18 to 70 years of age
- If asthmatic, currently taking a short acting beta agonist and an inhaled corticosteroid
- Never smoked or limited smoking history
Who cannot join
- Current upper respiratory illness (other than asthma)
- Illegal drug use within past month
- Consumption of more than 6 alcoholic drinks per week
- Active, pronounced rhinitis or sinusitis
- Pregnancy
- Currently taking oral steroids or steroid injection over the past month
- Asthma exacerbation over the past month
- Certain medical illnesses
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University, Emory Crawford Long Hospital, Clinical Research Center
Atlanta, Georgia, 30308
About this study
In the United States there has been a dramatic increase in the number of people who are obese and in the number of people who have asthma. Both are considered serious public health concerns. Several studies have shown that becoming obese or overweight can increase the risk of developing asthma or can make asthma symptoms more severe and difficult to control. How obesity affects asthma is not fully understood. This research study will examine whether obesity affects the amount of inflammation that is present in the lungs of people with asthma, and will also examine whether obesity leads to narrow and stiff airways.
Participation in this study involves 2 visits in order to complete questionnaires, various pulmonary function tests, as well as the collection of blood, urine, and exhaled breath condensate specimens.
This research study includes optional genetic and bronchoscopy substudies.
- Conditions
- Asthma
- Being tested
- No intervention
- Keywords
- asthma, inhaled corticosteroids
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Asthmatics Receives: Other: No intervention | |
| 2 | Healthy volunteers (without asthma) Receives: Other: No intervention |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startJan 2005
- Primary completionSep 2008
- Study completionSep 2008
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 Emory 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
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Critical Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615706
- Sponsor's protocol ID
- 345-2004
- Other IDs
- Emory IRB ID 345-2004
- Acronym
- ABI/BALA
- Status last verified
- Sep 2008
- First submitted
- 4 Feb 2008
- Last updated
- 23 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Impact of Obesity on Airway Inflammation and Mechanics in Asthmatics
- ClinicalTrials.gov ID
- NCT00615706
- Acronym / sponsor ID
- ABI/BALA / 345-2004
- Conditions
- Asthma
- Keywords
- asthma, inhaled corticosteroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Critical Therapeutics
- Study start
- Jan 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 14 Feb 2008 (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.
In the United States there has been a dramatic increase in the number of people who are obese and in the number of people who have asthma. Both are considered serious public health concerns. Several studies have shown that becoming obese or overweight can increase the risk of developing asthma or can make asthma symptoms more severe and difficult to control. How obesity affects asthma is not fully understood. This research study will examine whether obesity affects the amount of inflammation that is present in the lungs of people with asthma, and will also examine whether obesity leads to narrow and stiff airways.
Participation in this study involves 2 visits in order to complete questionnaires, various pulmonary function tests, as well as the collection of blood, urine, and exhaled breath condensate specimens.
This research study includes optional genetic and bronchoscopy substudies.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: No interventionAsthmatics |
| 2 | – | Other: No interventionHealthy volunteers (without asthma) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Asthmatics and healthy volunteers
Key inclusion criteria (3 listed)
- Adults 18 to 70 years of age
- If asthmatic, currently taking a short acting beta agonist and an inhaled corticosteroid
- Never smoked or limited smoking history
Key exclusion criteria (8 listed)
- Current upper respiratory illness (other than asthma)
- Illegal drug use within past month
- Consumption of more than 6 alcoholic drinks per week
- Active, pronounced rhinitis or sinusitis
- Pregnancy
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 |
|---|---|---|
| No interventionno intervention | Other | 1, 2 |
Primary outcome
Not reported in the source record.
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 23 Sep 2008.
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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.
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 Emory University at 1 site in United States.
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 8 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 23 Sep 2008. 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 United States. 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.
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 23 Sep 2008; AzTrials last refreshed its copy on 7 Nov 2026.