Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation

NCT02410096 | Completed

• 1 other identifier: KGU-360/14
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exercise-induced Asthma

Keywords

exercise-induced asthma; cold chamber; exercise challenge; cold air challenge; oil supplementation; middle-chain and Polyunsaturated Fatty Acids

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (2)

• Comparison of decrease in exhaled nitric oxide (eNO) as measured by Niox Mino (parts per billion, ppb)

  4 weeks

• Comparison of change in lipids in serum as measured by capillary gas chromatography (weight percent, wt%)

  4 weeks

Other Outcomes (1)

• Comparison of two methods of lung function testing as measured by spirometry (FEV1, percent predicted) and body plethysmography (specific airway resistance, sRAW, kPa*sec)

  4 weeks

Study Arms (2)

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.

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.

Other: Exercise challenge in a cold chamber; Other: Methacholine challenge; Dietary Supplement: Oil supplementation placebo

Interventions

Exercise challenge in a cold chamber OTHER

Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.

Oil supplementation placebo; Oil supplementation verum

Methacholine challenge OTHER

Nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg

Oil supplementation placebo; Oil supplementation verum

Oil supplementation verum DIETARY_SUPPLEMENT

Patients and subjects will take double blind an oil supplementation with middle-chain and polyunsaturated fatty acids for four weeks

Oil supplementation verum

Oil supplementation placebo DIETARY_SUPPLEMENT

Patients and subjects will take double blind sunflower oil for four weeks

Oil supplementation placebo

Eligibility Criteria

• Age: 12 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

Goethe University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (9)

• 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.

  PMID: 19001792 BACKGROUND

• Schulze 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.

  PMID: 22326606 BACKGROUND

• Nensa 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.

  PMID: 22826043 BACKGROUND

• Schulze 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.

  PMID: 19596563 BACKGROUND

• Dyerberg 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.

  PMID: 511010 BACKGROUND

• Endres 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.

  PMID: 2783477 BACKGROUND

• Mickleborough 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.

  PMID: 12904324 BACKGROUND

• Parsons 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.

  PMID: 23634861 BACKGROUND

• Dressler 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.

  PMID: 32660564 DERIVED

MeSH Terms

Conditions

Asthma, Exercise-Induced

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Johannes Schulze, MD

  Johann Wolfgang Goethe University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Pediatric Allergy and Pneumology

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: April 7, 2015
• Study Start: April 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 5, 2016

Record last verified: 2016-09

Locations

DE (1)