AsthmaPhase 2NCT01087710
Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children
A Phase 2 study testing medical food with EPA and GLA, vitamins and minerals and medical food minus EPA and GLA, antioxidant vitamins/minerals in people with Asthma, run by Abbott Nutrition at 1 site in United States.
Trial summary
To determine the effect of medical food on reducing asthma symptoms in asthmatic children. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Asthma
- What is being tested?
- medical food with EPA and GLA, vitamins and minerals and medical food minus EPA and GLA, antioxidant vitamins/minerals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jan 2006
- Phase
- Phase 2
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female children who have had mild to moderate persistent asthma for at least 1 year and are between 6 and 14 years of age, and not currently being treated with steroids are eligible.
- Each subject also has to have:
- Subject is off of controller therapy 4 wks preceding visit 1.
- Mild to moderate persistent asthma
- Methacholine responsiveness with an FEV1 PC20
- Able to perform reproducible spirometry
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- Verbal assent in addition to consent
- History of prior clinical varicella or varicella vaccine.
- Nonsmoker in past year.
Who cannot join
- Asthma symptoms and/or albuterol use consistent with severe persistent asthma during the run-in period.
- Subject with FEV1 < 80% predicted at visit 1 or FEV1 < 70% predicted at visit 2.
- Two or more hospitalizations for asthma in the past year.
- Subject has received oral, nasal, inhaled, or IM corticosteroids during the preceding month.
- Subject has received leukotriene modifiers, theophylline derivatives, or mast cell stabilizers for asthma within 4 weeks before visit 1
- Subject is receiving one or more of the following medications:
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- Astemizole prior to 3 months of visit 1
- Oral, inhaled or parenteral corticosteroids prior to 4 weeks of visit 1
- Cromolyn, antimuscarinics, cimetidine, metoclopramide, phenobarbital, phenytion, terfenadine, loratadine, or anticholingeric agents prior to 2 weeks of visit 1.
- Theophylline prior to 4 weeks of visit 1
- Subject with active upper respiratory tract infection prior to 4 weeks before visit 1
- Subject with acute sinus disease requiring antibiotic treatment within 1 week before visit
- Subject with an emergency department treatment for asthma within 1 month, prior intubation for asthma, or hospitalization for asthma within 3 months
- Subject has known bleeding disorder and/or is on medication known to have significant anticoagulant effects.
- Subject has known hypersensitivity to any of the ingredients
- Subject is taking either pill, powder, or liquid forms of nutritional and/or health food supplements within the past 4 weeks prior to visit
- Subject unable to tolerate or unwilling to take the full dose of the nutritional study formulas
- Cystic fibrosis or any other chronic lung disease other than asthma.
- Subject having gastroesophogeal reflux undergoing medical treatment
- Significant medical illness other than asthma that could require oral corticosteroids during the study.
- Subject is receiving allergen hyposensitization therapy other than an established maintenance regimen
- Subject has received IV globulins or immunosuppressants.
- Subject is known to be human immunodeficiency virus (HIV) positive.
- Pregnancy or lactation.
- If of child bearing potential, failure to practice abstinence or use of an acceptable birth control method.
- Subject is morbidly obese
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Novel Medical Food on Reducing the Frequency and Severity of Asthma Symptoms and Airway Hyper-responsiveness in Children With Mild to Moderate Persistent Asthma
To determine the effect of medical food on reducing asthma symptoms in asthmatic children.
- Conditions
- Asthma
- Being tested
- medical food with EPA and GLA, vitamins and minerals, medical food minus EPA and GLA, antioxidant vitamins/minerals
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical food with EPA and GLA, vitamins and mineralsOther
1 8oz serving per day for 12 weeks
medical food minus EPA and GLA, antioxidant vitamins/mineralsOther
1 8oz serving a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| novel nutritional formula | Experimental | Not described Receives: Other: medical food with EPA and GLA, vitamins and minerals |
| Control nutritional product | Active comparator | 1 8oz serving per day for 12 weeks Receives: Other: medical food minus EPA and GLA, antioxidant vitamins/minerals |
What is being measured
The primary outcome is the main question the study is designed to answer.
asthma free days
Measured: 12 weeks
Secondary outcomes (4)
reduction of airway hyper-responsiveness
Measured: 12 weeks
time to the first asthma exacerbation
Measured: 12 weeks
respiratory function (spirometry)
Measured: 12 weeks
need for rescue for exacerbations of asthma symptoms.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startJul 2004
- Primary completionDec 2005
- Study completionJan 2006
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stehen DeMichele, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087710
- Sponsor's protocol ID
- AK22
- Status last verified
- Mar 2010
- First submitted
- 8 Mar 2010
- Last updated
- 16 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Covar R, Gleason M, Macomber B, Stewart L, Szefler P, Engelhardt K, Murphy J, Liu A, Wood S, DeMichele S, Gelfand EW, Szefler SJ. Impact of a novel nutritional formula on asthma control and biomarkers of allergic airway inflammation in children. Clin Exp Allergy. 2010 Aug;40(8):1163-74. doi: 10.1111/j.1365-2222.2010.03523.x. Epub 2010 Jun 7.
PubMed 20545703
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Novel Medical Food on Reducing the Frequency and Severity of Asthma Symptoms and Airway Hyper-responsiveness in Children With Mild to Moderate Persistent Asthma
- ClinicalTrials.gov ID
- NCT01087710
- Acronym / sponsor ID
- AK22
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 16 Mar 2010 (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.
To determine the effect of medical food on reducing asthma symptoms in asthmatic children.
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 |
|---|---|---|
| novel nutritional formula | Experimental | Other: medical food with EPA and GLA, vitamins and minerals |
| Control nutritional product | Active comparator | Other: medical food minus EPA and GLA, antioxidant vitamins/minerals1 8oz serving per day for 12 weeks |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Male and female children who have had mild to moderate persistent asthma for at least 1 year and are between 6 and 14 years of age, and not currently being treated with steroids are eligible.
- Subject is off of controller therapy 4 wks preceding visit 1.
- Mild to moderate persistent asthma
- Methacholine responsiveness with an FEV1 PC20
- Able to perform reproducible spirometry
Key exclusion criteria (26 listed)
- Asthma symptoms and/or albuterol use consistent with severe persistent asthma during the run-in period.
- Subject with FEV1 < 80% predicted at visit 1 or FEV1 < 70% predicted at visit 2.
- Two or more hospitalizations for asthma in the past year.
- Subject has received oral, nasal, inhaled, or IM corticosteroids during the preceding month.
- Subject has received leukotriene modifiers, theophylline derivatives, or mast cell stabilizers for asthma within 4 weeks before visit 1
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 |
|---|---|---|
| medical food with EPA and GLA, vitamins and minerals1 8oz serving per day for 12 weeks | Other | novel nutritional formula |
| medical food minus EPA and GLA, antioxidant vitamins/minerals1 8oz serving a day for 12 weeks | Other | Control nutritional product |
Primary outcome
asthma free days
Time frame: 12 weeks
4 secondary outcomes
reduction of airway hyper-responsiveness
Time frame: 12 weeks
time to the first asthma exacerbation
Time frame: 12 weeks
respiratory function (spirometry)
Time frame: 12 weeks
need for rescue for exacerbations of asthma symptoms.
Time frame: 12 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 16 Mar 2010.
- Derived from this study: PubMed 20545703Covar R, Gleason M, Macomber B, Stewart L, Szefler P, Engelhardt K, Murphy J, Liu A, Wood S, DeMichele S, Gelfand EW, Szefler SJ. Impact of a novel nutritional formula on asthma control and biomarkers of allergic airway inflammation in children. Clin Exp Allergy. 2010 Aug;40(8):1163-74. doi: 10.1111/j.1365-2222.2010.03523.x. Epub 2010 Jun 7.
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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.
Stehen DeMichele, PhD study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing medical food with EPA and GLA, vitamins and minerals and medical food minus EPA and GLA, antioxidant vitamins/minerals in people with Asthma, run by Abbott Nutrition 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 9 inclusion and 26 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 16 Mar 2010. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 free days (time frame: 12 weeks). 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 NCT01087710, 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 16 Mar 2010.