Exercise-induced AsthmaNCT02410096
Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation
A study testing Exercise challenge in a cold chamber, Methacholine challenge and Oil supplementation verum in people with Exercise-induced Asthma, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The purpose of this study is to investigate the bronchial inflammation and hyperresponsiveness after oil supplementation. Before and after oil supplementation the investigators measure decrease in lung function after exercise-challenge in a cold chamber and increase of inflammatory markers in the blood. Read more about this study
- Who is it for?
- Ages 12 to 44 years
- Conditions the study is for
- Exercise-induced Asthma
- What is being tested?
- Exercise challenge in a cold chamber, Methacholine challenge and Oil supplementation verum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to Jul 2016
- Phase
- Interventional
- 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 12 to 44 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed consent
- Patients: Age ≥12 and 44 years
- known exercise induced asthma
- basic lung function FVC ≥ 75%, FEV1 ≥ 70%
- decrease in FEV1 after exercise ≥ 15%
Who cannot join
- lung function Forced vital capacity (FVC) <75% and Forced expiratory volume in 1 second (FEV1) <70%
- chronic diseases or infections (e.g. HIV, Tbc)
- pregnancy
- systemic corticosteroid-treatment
- inhalative corticosteroid therapy or leukotriene antagonists
- alcohol, substance or drug abuse
- smokers
- inability to capture extend and consequences of the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Goethe University Hospital Frankfurt
Frankfurt am Main, Hesse, 60590
About this study
Official title: Examination of Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation With Middle-chain and Polyunsaturated Fatty Acids in an Exercise-induced Asthma Provocation Model
The purpose of this study is to investigate the bronchial inflammation and hyperresponsiveness after oil supplementation. Before and after oil supplementation the investigators measure decrease in lung function after exercise-challenge in a cold chamber and increase of inflammatory markers in the blood.
Read the detailed description
Subjects suffering form exercise-induced bronchoconstriction (EIB) usually have a normal lung function testing at rest and show a decrease in lung function when they do sports or an exercise-challenge. In a previous study the investigators could show, that the combination of exercise test and inhalation of cold air ist more sensitive and specific than exercise-challenge in ambient temperature.
It is known that omega - 3 -fatty acids could reduce the production of inflammatory mediators.
In this study the investigators will investigate the protective effect of oil supplementation with middle-chain and polyunsaturated fatty acids in an exercise-induced asthma provocation model.
Therefore the investigators will measure the decrease in lung function and a increase of inflammatory markers in the blood before and after oil supplementation.
Before and after the exercise-challenge the investigators will measure spirometry and body plethysmography. The investigators want to examine if the body plethysmography is more sensitive in the measurement of exercise induced bronchoconstriction than spirometry.
The investigators hypothesize that the oil supplementation can reduce bronchial inflammation and hyperresponsiveness.
- Conditions
- Exercise-induced Asthma
- Being tested
- Exercise challenge in a cold chamber, Methacholine challenge, Oil supplementation verum, Oil supplementation placebo
- Keywords
- exercise-induced asthma, cold chamber, exercise challenge, cold air challenge, oil supplementation, middle-chain and Polyunsaturated Fatty Acids
- Medical subject headings
- Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise challenge in a cold chamberOther
Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.
Methacholine challengeOther
Nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg
Oil supplementation verumDietary supplement
Patients and subjects will take double blind an oil supplementation with middle-chain and polyunsaturated fatty acids for four weeks
Oil supplementation placeboDietary supplement
Patients and subjects will take double blind sunflower oil for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Oil supplementation verum | Active comparator | 30 patients aged 12-44 years with a diagnosis of exercise induced asthma undergo a methacholine challenge and a prick test. After randomization patients will receive in double blind approach ones daily 1190 mg of middle-chain and polyunsaturated fatty acids for four weeks. Before and after supplementation an exercise challenge in a cold chamber will be performed. Receives: Other: Exercise challenge in a cold chamber; Other: Methacholine challenge; Dietary Supplement: Oil supplementation verum |
| Oil supplementation placebo | Placebo comparator | 30 patients aged 12-44 years with a diagnosis of exercise induced asthma undergo a methacholine challenge and a prick test. After randomization patients will receive in double blind approach placebo for four weeks. Before and after placebo treatment an exercise challenge in a cold chamber will be performed. Receives: Other: Exercise challenge in a cold chamber; Other: Methacholine challenge; Dietary Supplement: Oil supplementation placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in FEV1 after exercise challenge in cold air as measured by spirometry (FEV1, percent predicted) - comparison verum vs placebo
The exercise challenge in cold air will be done on two timepoints. Before and after oil supplementation versus placebo supplementation. After exercise challenge spirometry will be measured. Decrease in FEV1 in verum and control group will be compared with t-test and Wilcoxon-Mann-Whitney-Test.
Measured: 4 weeks
Secondary outcomes (2)
Comparison of decrease in exhaled nitric oxide (eNO) as measured by Niox Mino (parts per billion, ppb)
Comparison of decrease in eNO before and after supplementation in verum and placebo group
Measured: 4 weeks
Comparison of change in lipids in serum as measured by capillary gas chromatography (weight percent, wt%)
Comparison of increase eicosapentaenoic acid and docosahexaenoic acid and decrease of triglycerides before and after supplementation in verum and placebo group
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Exercise-induced 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Schulze MD, Johann Wolfgang Goethe University Hospital
- Investigators
- Johannes Schulze, MD, Principal investigator, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410096
- Sponsor's protocol ID
- KGU-360/14
- Status last verified
- Sep 2016
- First submitted
- 18 Mar 2015
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Schubert R, Kitz R, Beermann C, Rose MA, Lieb A, Sommerer PC, Moskovits J, Alberternst H, Bohles HJ, Schulze J, Zielen S. Effect of n-3 polyunsaturated fatty acids in asthma after low-dose allergen challenge. Int Arch Allergy Immunol. 2009;148(4):321-9. doi: 10.1159/000170386. Epub 2008 Nov 11.
PubMed 19001792Schulze J, Smith HJ, Fuchs J, Herrmann E, Dressler M, Rose MA, Zielen S. Methacholine challenge in young children as evaluated by spirometry and impulse oscillometry. Respir Med. 2012 May;106(5):627-34. doi: 10.1016/j.rmed.2012.01.007. Epub 2012 Feb 10.
PubMed 22326606Nensa F, Kotschy-Lang N, Smith HJ, Marek W, Merget R. Assessment of airway hyperresponsiveness: comparison of spirometry and body plethysmography. Adv Exp Med Biol. 2013;755:1-9. doi: 10.1007/978-94-007-4546-9_1.
PubMed 22826043Schulze J, Rosewich M, Riemer C, Dressler M, Rose MA, Zielen S. Methacholine challenge--comparison of an ATS protocol to a new rapid single concentration technique. Respir Med. 2009 Dec;103(12):1898-903. doi: 10.1016/j.rmed.2009.06.007. Epub 2009 Jul 10.
PubMed 19596563Dyerberg J, Bang HO. Lipid metabolism, atherogenesis, and haemostasis in Eskimos: the role of the prostaglandin-3 family. Haemostasis. 1979;8(3-5):227-33. doi: 10.1159/000214314.
PubMed 511010Endres S, Ghorbani R, Kelley VE, Georgilis K, Lonnemann G, van der Meer JW, Cannon JG, Rogers TS, Klempner MS, Weber PC, et al. The effect of dietary supplementation with n-3 polyunsaturated fatty acids on the synthesis of interleukin-1 and tumor necrosis factor by mononuclear cells. N Engl J Med. 1989 Feb 2;320(5):265-71. doi: 10.1056/NEJM198902023200501.
PubMed 2783477Mickleborough TD, Murray RL, Ionescu AA, Lindley MR. Fish oil supplementation reduces severity of exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Nov 15;168(10):1181-9. doi: 10.1164/rccm.200303-373OC. Epub 2003 Aug 6.
PubMed 12904324Parsons JP, Hallstrand TS, Mastronarde JG, Kaminsky DA, Rundell KW, Hull JH, Storms WW, Weiler JM, Cheek FM, Wilson KC, Anderson SD; American Thoracic Society Subcommittee on Exercise-induced Bronchoconstriction. An official American Thoracic Society clinical practice guideline: exercise-induced bronchoconstriction. Am J Respir Crit Care Med. 2013 May 1;187(9):1016-27. doi: 10.1164/rccm.201303-0437ST.
PubMed 23634861Dressler M, Fussbroich D, Bohler L, Herrmann E, Benker N, Tytyk M, Schulze J, Schubert R, Beermann C, Zielen S. Oil supplementation with a special combination of n-3 and n-6 long-chain polyunsaturated fatty acids does not protect for exercise induced asthma: a double-blind placebo-controlled trial. Lipids Health Dis. 2020 Jul 13;19(1):167. doi: 10.1186/s12944-020-01343-2.
PubMed 32660564
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation With Middle-chain and Polyunsaturated Fatty Acids in an Exercise-induced Asthma Provocation Model
- ClinicalTrials.gov ID
- NCT02410096
- Acronym / sponsor ID
- KGU-360/14
- Conditions
- Exercise-induced Asthma
- Keywords
- exercise-induced asthma, cold chamber, exercise challenge, cold air challenge, oil supplementation, middle-chain and Polyunsaturated Fatty Acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Apr 2015 (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.
The purpose of this study is to investigate the bronchial inflammation and hyperresponsiveness after oil supplementation. Before and after oil supplementation the investigators measure decrease in lung function after exercise-challenge in a cold chamber and increase of inflammatory markers in the blood.
Detailed description
Subjects suffering form exercise-induced bronchoconstriction (EIB) usually have a normal lung function testing at rest and show a decrease in lung function when they do sports or an exercise-challenge. In a previous study the investigators could show, that the combination of exercise test and inhalation of cold air ist more sensitive and specific than exercise-challenge in ambient temperature.
It is known that omega - 3 -fatty acids could reduce the production of inflammatory mediators.
In this study the investigators will investigate the protective effect of oil supplementation with middle-chain and polyunsaturated fatty acids in an exercise-induced asthma provocation model.
Therefore the investigators will measure the decrease in lung function and a increase of inflammatory markers in the blood before and after oil supplementation.
Before and after the exercise-challenge the investigators will measure spirometry and body plethysmography. The investigators want to examine if the body plethysmography is more sensitive in the measurement of exercise induced bronchoconstriction than spirometry.
The investigators hypothesize that the oil supplementation can reduce bronchial inflammation and hyperresponsiveness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oil supplementation verum | Active comparator | Other: Exercise challenge in a cold chamber, Other: Methacholine challenge, Dietary Supplement: Oil supplementation verum30 patients aged 12-44 years with a diagnosis of exercise induced asthma undergo a methacholine challenge and a prick test. After randomization patients will receive in double blind approach ones daily 1190 mg of middle-chain and polyunsaturated fatty acids for four weeks. Before and after supplementation an exercise challenge in a cold chamber will be performed. |
| Oil supplementation placebo | Placebo comparator | Other: Exercise challenge in a cold chamber, Other: Methacholine challenge, Dietary Supplement: Oil supplementation placebo30 patients aged 12-44 years with a diagnosis of exercise induced asthma undergo a methacholine challenge and a prick test. After randomization patients will receive in double blind approach placebo for four weeks. Before and after placebo treatment an exercise challenge in a cold chamber will be performed. |
Who may qualify
- Ages
- 12 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Informed consent
- Patients: Age ≥12 and 44 years
- known exercise induced asthma
- basic lung function FVC ≥ 75%, FEV1 ≥ 70%
- decrease in FEV1 after exercise ≥ 15%
Key exclusion criteria (8 listed)
- lung function Forced vital capacity (FVC) <75% and Forced expiratory volume in 1 second (FEV1) <70%
- chronic diseases or infections (e.g. HIV, Tbc)
- pregnancy
- systemic corticosteroid-treatment
- inhalative corticosteroid therapy or leukotriene antagonists
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 |
|---|---|---|
| Exercise challenge in a cold chamberExercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber. | Other | Oil supplementation placebo, Oil supplementation verum |
| Methacholine challengeNebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg | Other | Oil supplementation placebo, Oil supplementation verum |
| Oil supplementation verumPatients and subjects will take double blind an oil supplementation with middle-chain and polyunsaturated fatty acids for four weeks | Dietary supplement | Oil supplementation verum |
| Oil supplementation placeboPatients and subjects will take double blind sunflower oil for four weeks | Dietary supplement | Oil supplementation placebo |
Primary outcome
Decrease in FEV1 after exercise challenge in cold air as measured by spirometry (FEV1, percent predicted) - comparison verum vs placebo
Time frame: 4 weeks
The exercise challenge in cold air will be done on two timepoints. Before and after oil supplementation versus placebo supplementation. After exercise challenge spirometry will be measured. Decrease in FEV1 in verum and control group will be compared with t-test and Wilcoxon-Mann-Whitney-Test.
2 secondary outcomes
Comparison of decrease in exhaled nitric oxide (eNO) as measured by Niox Mino (parts per billion, ppb)
Time frame: 4 weeks
Comparison of change in lipids in serum as measured by capillary gas chromatography (weight percent, wt%)
Time frame: 4 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 5 Sep 2016.
- Background: PubMed 19001792Schubert R, Kitz R, Beermann C, Rose MA, Lieb A, Sommerer PC, Moskovits J, Alberternst H, Bohles HJ, Schulze J, Zielen S. Effect of n-3 polyunsaturated fatty acids in asthma after low-dose allergen challenge. Int Arch Allergy Immunol. 2009;148(4):321-9. doi: 10.1159/000170386. Epub 2008 Nov 11.
- Background: PubMed 22326606Schulze J, Smith HJ, Fuchs J, Herrmann E, Dressler M, Rose MA, Zielen S. Methacholine challenge in young children as evaluated by spirometry and impulse oscillometry. Respir Med. 2012 May;106(5):627-34. doi: 10.1016/j.rmed.2012.01.007. Epub 2012 Feb 10.
- Background: PubMed 22826043Nensa F, Kotschy-Lang N, Smith HJ, Marek W, Merget R. Assessment of airway hyperresponsiveness: comparison of spirometry and body plethysmography. Adv Exp Med Biol. 2013;755:1-9. doi: 10.1007/978-94-007-4546-9_1.
- Background: PubMed 19596563Schulze J, Rosewich M, Riemer C, Dressler M, Rose MA, Zielen S. Methacholine challenge--comparison of an ATS protocol to a new rapid single concentration technique. Respir Med. 2009 Dec;103(12):1898-903. doi: 10.1016/j.rmed.2009.06.007. Epub 2009 Jul 10.
- Background: PubMed 511010Dyerberg J, Bang HO. Lipid metabolism, atherogenesis, and haemostasis in Eskimos: the role of the prostaglandin-3 family. Haemostasis. 1979;8(3-5):227-33. doi: 10.1159/000214314.
- Background: PubMed 2783477Endres S, Ghorbani R, Kelley VE, Georgilis K, Lonnemann G, van der Meer JW, Cannon JG, Rogers TS, Klempner MS, Weber PC, et al. The effect of dietary supplementation with n-3 polyunsaturated fatty acids on the synthesis of interleukin-1 and tumor necrosis factor by mononuclear cells. N Engl J Med. 1989 Feb 2;320(5):265-71. doi: 10.1056/NEJM198902023200501.
- Background: PubMed 12904324Mickleborough TD, Murray RL, Ionescu AA, Lindley MR. Fish oil supplementation reduces severity of exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Nov 15;168(10):1181-9. doi: 10.1164/rccm.200303-373OC. Epub 2003 Aug 6.
- Background: PubMed 23634861Parsons JP, Hallstrand TS, Mastronarde JG, Kaminsky DA, Rundell KW, Hull JH, Storms WW, Weiler JM, Cheek FM, Wilson KC, Anderson SD; American Thoracic Society Subcommittee on Exercise-induced Bronchoconstriction. An official American Thoracic Society clinical practice guideline: exercise-induced bronchoconstriction. Am J Respir Crit Care Med. 2013 May 1;187(9):1016-27. doi: 10.1164/rccm.201303-0437ST.
- Derived from this study: PubMed 32660564Dressler M, Fussbroich D, Bohler L, Herrmann E, Benker N, Tytyk M, Schulze J, Schubert R, Beermann C, Zielen S. Oil supplementation with a special combination of n-3 and n-6 long-chain polyunsaturated fatty acids does not protect for exercise induced asthma: a double-blind placebo-controlled trial. Lipids Health Dis. 2020 Jul 13;19(1):167. doi: 10.1186/s12944-020-01343-2.
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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.
Johannes Schulze, MD principal investigator
Johann Wolfgang Goethe University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise challenge in a cold chamber, Methacholine challenge and Oil supplementation verum in people with Exercise-induced Asthma, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 5 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 5 Sep 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 Germany. 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.
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?
Decrease in FEV1 after exercise challenge in cold air as measured by spirometry (FEV1, percent predicted) - comparison verum vs placebo (time frame: 4 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 NCT02410096, which also lists 9 linked publications.
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 5 Sep 2016; AzTrials last refreshed its copy on 30 Oct 2026.