AsthmaNCT00557180
Examining the Link Between Obesity, Inflammation, and Response to Asthma Medications
An observational study of Asthma and Obesity, run by National Jewish Health at 10 sites in United States.
Trial summary
Asthma is a common, long-term disease that is caused by inflammation of the airways. Inflammation also plays a role in obesity and may affect the way a person responds to asthma medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Beclomethasone dipropionate HFA, Tiotropium bromide and Salmeterol xinafoate
- How many people
- 33 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2007to Feb 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in the BASALT and TALC studies. Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancilary to those trials and observational only and does not have any control over study drug allocation
Who may be able to join
- Participation in either the BASALT or TALC studies of the Asthma Clinical Research Network. Inclusion and exclusion criteria are as determined by those studies, NCT00495157, NCT00565266.
Who cannot join
None listed.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
National Jewish Medical & Research Center
Denver, Colorado, 80206
Duke University Medical Center
Durham, North Carolina, 27710
University of Texas Medical Branch
Galveston, Texas, 77555
University of Wisconsin
Madison, Wisconsin, 53706
Columbia University Medical Center
New York, New York, 10032
University of California, San Diego
San Diego, California, 92093
University of California, San Francisco
San Francisco, California, 94143
Washington University
St Louis, Missouri, 63130
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Obesity, Inflammation and Response to Therapy in Asthma - Ancillary to Asthma Clinical Research Network (ACRN) Trials
Asthma is a common, long-term disease that is caused by inflammation of the airways. Inflammation also plays a role in obesity and may affect the way a person responds to asthma medication. This study will examine the relationship between obesity and inflammation and the effect they have on response to corticosteroid asthma medications.
Read the detailed description
Asthma affects 20 million people in the United States. It can be caused by many factors, including exposure to tobacco smoke, infections, and other allergens. Recent research suggests that there may be a relationship between obesity and asthma. It is not fully understood how these two conditions are linked, but inflammation may play a role. Obesity-related inflammation may increase the risk of airway inflammation, thereby elevating the risk of developing asthma. Increased inflammation related to obesity may also reduce the effectiveness of inhaled steroid asthma medications, including glucocorticoids. Compared with people of normal weight, people who are overweight or obese may have a higher risk of developing glucocorticoid insensitivity, resulting in intolerance to glucocorticoid medications. The purpose of this study is to examine the effect that obesity has on glucocorticoid insensitivity and inflammation. This study will also examine differences in the response to asthma steroid medications between people who are overweight or obese and those who are not.
This study will use previously collected data from participants in two clinical trials of the NHLBI-funded Asthma Clinical Research Network (ACRN): the Best Adjustment Strategy for Asthma in Long Term (BASALT) study (NCT00495157) and the Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC) study. There will be no additional study visits specifically for this study. Researchers will examine blood samples collected at participants' first BASALT or TALC study visit to analyze levels of inflammation biomarkers (including tumor necrosis factor-alpha [TNF-α], interleukin-6 [IL-6], and leptin) and proinflammatory cytokines levels, which influence glucocorticoid insensitivity. Additional BASALT and TALC study data, including lung function, asthma symptoms, and asthma exacerbations, will also be analyzed.
- Being tested
- Beclomethasone dipropionate HFA, Tiotropium bromide, Salmeterol xinafoate
- Keywords
- Steroid Resistance, Inflammation
- Medical subject headings
- Asthma, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclomethasone dipropionate HFADrug
Also called QVAR® 40 mcg or QVAR® 80 mcg
Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
Tiotropium bromideDrug
Also called Spiriva®
Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
Salmeterol xinafoateDrug
Also called Serevent®
Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
| Study group | Role | What they receive |
|---|---|---|
| BASALT | Participants in the ACRN BASALT study Receives: Drug: Beclomethasone dipropionate HFA | |
| TALC | Participants in the ACRN TALC study Receives: Drug: Tiotropium bromide; Drug: Salmeterol xinafoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of lung function; asthma symptoms and exacerbations; quality of life; rescue medication usage; inflammation and oxidative stress biomarkers; and the effect these factors have on glucocorticoid insensitivity
Measured: Measured at Week 36 for BASALT participants and Week 46 for TALC participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- E. R. Sutherland, MD, MPH, Principal investigator, National Jewish Medical & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557180
- Sponsor's protocol ID
- 1423
- Other IDs
- R01HL090982
- Status last verified
- Oct 2020
- First submitted
- 9 Nov 2007
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sutherland ER, Goleva E, Jackson LP, Stevens AD, Leung DY. Vitamin D levels, lung function, and steroid response in adult asthma. Am J Respir Crit Care Med. 2010 Apr 1;181(7):699-704. doi: 10.1164/rccm.200911-1710OC. Epub 2010 Jan 14.
PubMed 20075384
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity, Inflammation and Response to Therapy in Asthma - Ancillary to Asthma Clinical Research Network (ACRN) Trials
- ClinicalTrials.gov ID
- NCT00557180
- Acronym / sponsor ID
- 1423
- Keywords
- Steroid Resistance, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2007 (actual)
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 12 Nov 2007 (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 common, long-term disease that is caused by inflammation of the airways. Inflammation also plays a role in obesity and may affect the way a person responds to asthma medication. This study will examine the relationship between obesity and inflammation and the effect they have on response to corticosteroid asthma medications.
Detailed description
Asthma affects 20 million people in the United States. It can be caused by many factors, including exposure to tobacco smoke, infections, and other allergens. Recent research suggests that there may be a relationship between obesity and asthma. It is not fully understood how these two conditions are linked, but inflammation may play a role. Obesity-related inflammation may increase the risk of airway inflammation, thereby elevating the risk of developing asthma. Increased inflammation related to obesity may also reduce the effectiveness of inhaled steroid asthma medications, including glucocorticoids. Compared with people of normal weight, people who are overweight or obese may have a higher risk of developing glucocorticoid insensitivity, resulting in intolerance to glucocorticoid medications. The purpose of this study is to examine the effect that obesity has on glucocorticoid insensitivity and inflammation. This study will also examine differences in the response to asthma steroid medications between people who are overweight or obese and those who are not.
This study will use previously collected data from participants in two clinical trials of the NHLBI-funded Asthma Clinical Research Network (ACRN): the Best Adjustment Strategy for Asthma in Long Term (BASALT) study (NCT00495157) and the Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC) study. There will be no additional study visits specifically for this study. Researchers will examine blood samples collected at participants' first BASALT or TALC study visit to analyze levels of inflammation biomarkers (including tumor necrosis factor-alpha [TNF-α], interleukin-6 [IL-6], and leptin) and proinflammatory cytokines levels, which influence glucocorticoid insensitivity. Additional BASALT and TALC study data, including lung function, asthma symptoms, and asthma exacerbations, will also be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BASALT | – | Drug: Beclomethasone dipropionate HFAParticipants in the ACRN BASALT study |
| TALC | – | Drug: Tiotropium bromide, Drug: Salmeterol xinafoateParticipants in the ACRN TALC study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in the BASALT and TALC studies. Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancilary to those trials and observational only and does not have any control over study drug allocation
Key inclusion criteria (1 listed)
- Participation in either the BASALT or TALC studies of the Asthma Clinical Research Network. Inclusion and exclusion criteria are as determined by those studies, NCT00495157, NCT00565266.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Beclomethasone dipropionate HFAAlso: QVAR® 40 mcg or QVAR® 80 mcgParticipants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation | Drug | BASALT |
| Tiotropium bromideAlso: Spiriva®Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation | Drug | TALC |
| Salmeterol xinafoateAlso: Serevent®Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation | Drug | TALC |
Primary outcome
Measures of lung function; asthma symptoms and exacerbations; quality of life; rescue medication usage; inflammation and oxidative stress biomarkers; and the effect these factors have on glucocorticoid insensitivity
Time frame: Measured at Week 36 for BASALT participants and Week 46 for TALC participants
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 22 Oct 2020.
- Derived from this study: PubMed 20075384Sutherland ER, Goleva E, Jackson LP, Stevens AD, Leung DY. Vitamin D levels, lung function, and steroid response in adult asthma. Am J Respir Crit Care Med. 2010 Apr 1;181(7):699-704. doi: 10.1164/rccm.200911-1710OC. Epub 2010 Jan 14.
- Click here for the Asthma Clinical Research Network (ACRN) Web site.Link 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.
E. R. Sutherland, MD, MPH principal investigator
National Jewish Medical & Research Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Obesity, run by National Jewish Health at 10 sites 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 1 inclusion and 0 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does the primary outcome measure?
Measures of lung function; asthma symptoms and exacerbations; quality of life; rescue medication usage; inflammation and oxidative stress biomarkers; and the effect these factors have on glucocorticoid insensitivity (time frame: Measured at Week 36 for BASALT participants and Week 46 for TALC participants). 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 NCT00557180, which also lists 1 linked publication.
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 22 Oct 2020.