AsthmaPhase 2/3NOOANCT01027143
Obesity and Asthma: Nutrigenetic Response to Omega-3 Fatty Acids
A Phase 2/3 study testing omega-3 polyunsaturated fatty acids and Omega-3 Fatty Acid in people with Asthma and Obesity, run by Nemours Children's Clinic at 3 sites in United States.
Trial summary
This project will assess the effectiveness of omega-3 fatty acid supplementation in controlling asthma symptoms among obese asthmatics, and will assess if a person's genes influence response to treatment (personalized medicine). Read more about this study
- Who is it for?
- Ages 12 to 25 years
- What is being tested?
- omega-3 polyunsaturated fatty acids and Omega-3 Fatty Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2010to 22 Oct 2016
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 12-25
- BMI > 25 (age 18-25) or BMI%>85th (age 12-17) (BMI Liberalized)
- Physician diagnosis of persistent asthma
- Lung function responsiveness by bronchodilator reversibility or bronchoprovocation testing
Who cannot join
- pregnancy
- currently taking LTRA for asthma control
- other serious chronic medical condition
- bleeding diathesis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Nemours Children's Clinic
Jacksonville, Florida, 32207
Nemours Children's Hospital/Dept of Pulmonology
Orlando, Florida, 32827
University of South Florida, Morsani College of Medicine
Tampa, Florida, 33612
About this study
Official title: Obesity & Asthma: Nutrigenetic Response to Omega-3 Fatty Acids
This project will assess the effectiveness of omega-3 fatty acid supplementation in controlling asthma symptoms among obese asthmatics, and will assess if a person's genes influence response to treatment (personalized medicine). This project may improve our ability to treat asthma and our understanding of the link between obesity and asthma.
Read the detailed description
Obesity increases the risk for asthma diagnosis in children and adults. With obesity on the rise, a better understanding of this association may become critically important to public health. We will determine the impact of fish oil-derived Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) on asthma control among obese asthmatics. These omega-3 fatty acids have been shown to: reduce inflammation important to asthma and improve asthma outcomes in an inconsistent manner across previous smaller studies - results that are consistent with a pharmacogenetic influence. There exists evidence that omega-3 fatty acid response displays a pharmacogenetic response related to ALOX5 genotype. Preliminary data suggests that obese individuals are at greater risk for possessing this same ALOX5 variant and thus obese asthmatics may be more responsive to fish oil. We will determine (in a sub-aim) if there exists an ALOX5 genotype-related response effect with fish oil. This will be the largest clinical trial of omega-3 fatty acid for the treatment of asthma, and the first applying pharmacogenetic/nutrigenetic analysis.
- Being tested
- omega-3 polyunsaturated fatty acids, Omega-3 Fatty Acid
- Keywords
- Asthma, Obesity, Pharmacogenetics, Nutrigenetics
- Medical subject headings
- Asthma, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 polyunsaturated fatty acidsDietary supplement
Also called ProEPA Xtra 1000mg softgels
ProEPA Xtra 1000mg softgels: 3 softgels twice daily
Omega-3 Fatty AcidDrug
Also called Placebo Soybean oil 1000mg soft gels
Soybean oil: 3(age 12-25) matched softgel caps twice daily
| Study group | Role | What they receive |
|---|---|---|
| omega-3 fatty acids | Experimental | 3 softgels (EPA, DHA) twice daily Receives: Dietary Supplement: omega-3 polyunsaturated fatty acids |
| control | Placebo comparator | Soybean oil: 3 matched softgel caps twice daily Receives: Drug: Omega-3 Fatty Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Questionnaire (Juniper)
The ACQ ranges from 0 to 6 (higher values indicate worse asthma control). A score greater than 1.25 in children is considered poor asthma control, and a change of 0.4 or greater is considered clinical meaningful.
Measured: baseline, 3 months, 6 months
Secondary outcomes (7)
N3-to-n6 PUFA Ratio (Granulocytes)
Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from granulocytes in peripheral blood
Measured: Baseline, 3 and 6 months
N3-to-n6 PUFA Ratio (Monocytes)
Ratio of total omega-3 to total omega-6 polyunsaturated fatty acids from monocytes in peripheral blood
Measured: Baseline, 3 months, 6 months
Asthma Control Test
The asthma control test assesses patient reported symptoms from the prior month and has a range from 5 to 25 with a higher score suggesting better asthma control.
Measured: Baseline, 3 months, 6 months
Urinary Leukotriene-E4
Leukotriene E4 obtained from urine was measured using liquid chromatography tandem mass spectrometry.
Measured: Baseline, 3 months, 6 months
FEV1
Forced expiratory volume in 1 second is a validated spirometry measure.
Measured: Baseline, 3 months, 6 months
Exacerbations
Exacerbations of asthma were defined by the need for urgent medical care (emergency room or urgent care clinic) or systemic corticosteroids to avoid severe worsening of asthma determined by study physician or local provider
Measured: 6 months
Phone Contacts
Phone contact was defined as an urgent or unscheduled phone contact to a medical provider for asthma
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startJul 2010
- Primary completion22 Oct 2016
- Study completion22 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Office of Dietary Supplements (ODS)
- Responsible party
- Sponsor
- Investigators
- Jason E. Lang, M.D., Principal investigator, Duke Children's Hospital and Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027143
- Sponsor's protocol ID
- NCCJELK23
- Acronym
- NOOA
- Status last verified
- Mar 2016
- First submitted
- 3 Dec 2009
- Last updated
- 8 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lang JE, Mougey EB, Hossain MJ, Livingston F, Balagopal PB, Langdon S, Lima JJ. Fish Oil Supplementation in Overweight/Obese Patients with Uncontrolled Asthma. A Randomized Trial. Ann Am Thorac Soc. 2019 May;16(5):554-562. doi: 10.1513/AnnalsATS.201807-446OC.
PubMed 30678465
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity & Asthma: Nutrigenetic Response to Omega-3 Fatty Acids
- ClinicalTrials.gov ID
- NCT01027143
- Acronym / sponsor ID
- NOOA / NCCJELK23
- Keywords
- Asthma, Obesity, Pharmacogenetics, Nutrigenetics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Office of Dietary Supplements (ODS)
- Study start
- Jul 2010
- Primary completion
- 22 Oct 2016 (actual)
- Study completion
- 22 Oct 2016 (actual)
- First posted
- 7 Dec 2009 (estimated)
- Results
- Posted 8 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will assess the effectiveness of omega-3 fatty acid supplementation in controlling asthma symptoms among obese asthmatics, and will assess if a person's genes influence response to treatment (personalized medicine). This project may improve our ability to treat asthma and our understanding of the link between obesity and asthma.
Detailed description
Obesity increases the risk for asthma diagnosis in children and adults. With obesity on the rise, a better understanding of this association may become critically important to public health. We will determine the impact of fish oil-derived Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) on asthma control among obese asthmatics. These omega-3 fatty acids have been shown to: reduce inflammation important to asthma and improve asthma outcomes in an inconsistent manner across previous smaller studies - results that are consistent with a pharmacogenetic influence. There exists evidence that omega-3 fatty acid response displays a pharmacogenetic response related to ALOX5 genotype. Preliminary data suggests that obese individuals are at greater risk for possessing this same ALOX5 variant and thus obese asthmatics may be more responsive to fish oil. We will determine (in a sub-aim) if there exists an ALOX5 genotype-related response effect with fish oil. This will be the largest clinical trial of omega-3 fatty acid for the treatment of asthma, and the first applying pharmacogenetic/nutrigenetic analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omega-3 fatty acids | Experimental | Dietary Supplement: omega-3 polyunsaturated fatty acids3 softgels (EPA, DHA) twice daily |
| control | Placebo comparator | Drug: Omega-3 Fatty AcidSoybean oil: 3 matched softgel caps twice daily |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- age 12-25
- BMI > 25 (age 18-25) or BMI%>85th (age 12-17) (BMI Liberalized)
- Physician diagnosis of persistent asthma
- Lung function responsiveness by bronchodilator reversibility or bronchoprovocation testing
Key exclusion criteria (4 listed)
- pregnancy
- currently taking LTRA for asthma control
- other serious chronic medical condition
- bleeding diathesis
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 |
|---|---|---|
| omega-3 polyunsaturated fatty acidsAlso: ProEPA Xtra 1000mg softgelsProEPA Xtra 1000mg softgels: 3 softgels twice daily | Dietary supplement | omega-3 fatty acids |
| Omega-3 Fatty AcidAlso: Placebo Soybean oil 1000mg soft gelsSoybean oil: 3(age 12-25) matched softgel caps twice daily | Drug | control |
Primary outcome
Asthma Control Questionnaire (Juniper)
Time frame: baseline, 3 months, 6 months
The ACQ ranges from 0 to 6 (higher values indicate worse asthma control). A score greater than 1.25 in children is considered poor asthma control, and a change of 0.4 or greater is considered clinical meaningful.
7 secondary outcomes
N3-to-n6 PUFA Ratio (Granulocytes)
Time frame: Baseline, 3 and 6 months
N3-to-n6 PUFA Ratio (Monocytes)
Time frame: Baseline, 3 months, 6 months
Asthma Control Test
Time frame: Baseline, 3 months, 6 months
Urinary Leukotriene-E4
Time frame: Baseline, 3 months, 6 months
FEV1
Time frame: Baseline, 3 months, 6 months
Exacerbations
Time frame: 6 months
Phone Contacts
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30678465Lang JE, Mougey EB, Hossain MJ, Livingston F, Balagopal PB, Langdon S, Lima JJ. Fish Oil Supplementation in Overweight/Obese Patients with Uncontrolled Asthma. A Randomized Trial. Ann Am Thorac Soc. 2019 May;16(5):554-562. doi: 10.1513/AnnalsATS.201807-446OC.
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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.
Jason E. Lang, M.D. principal investigator
Duke Children's Hospital and Health Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing omega-3 polyunsaturated fatty acids and Omega-3 Fatty Acid in people with Asthma and Obesity, run by Nemours Children's Clinic at 3 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 4 inclusion and 4 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 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Questionnaire (Juniper) (time frame: baseline, 3 months, 6 months). 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 NCT01027143, 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 8 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.