Allergic AsthmaLCPUFANCT04109534
Effect of a Dietary Fatty Acid Supplementation on Symptoms and Bronchial Inflammation in Patients With Asthma
A study testing Bronchial allergen provocation (BAP), Nasal provocation test (NPT) and Methacholine test in people with Allergic Asthma and Allergy to House Dust Mite, run by Stefan Zielen at 1 site in Germany.
Trial summary
The proposed study will investigate the effect of a polyunsaturated fatty acid / lipid mixture (LCPUFAs) on the clinical symptoms, bronchial inflammation and lung function in allergic asthma in a bronchial allergen provocation (BAP) model. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Allergic Asthma, Allergy to House Dust Mite
- What is being tested?
- Bronchial allergen provocation (BAP), Nasal provocation test (NPT) and Methacholine test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2019to 30 Dec 2020
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent
- Patients: aged ≥18 and 45 years
- known allergen induced asthma and HDM-Allergy
- basic lung function FVC ≥ 80%, FEV1 ≥ 75%
- decrease in FEV1 after BAP ≥ 20%
- 30% increase of NO after BAP
Who cannot join
- lung function Forced vital capacity (FVC) <80% and Forced expiratory volume in 1 second (FEV1) <75%
- chronic diseases or infections (e.g. HIV, Tbc)
- pregnancy
- systemic corticosteroid-treatment
- inhalative corticosteroid therapy or leukotriene antagonists
- alcohol, substance or drug abuse
- current smokers
- inability to capture extend and consequences of the study
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Kinder- und Jugendmedizin Universitätsklinikum
Frankfurt am Main, Hesse, 60590
Stefan Zielen, Professor, +49 696301 ext. 83063, Stefan.zielen@kgu.de
Paola JE Gnago, MD, +4915780560152, Paola.Gnago@kgu.de
About this study
Official title: Investigation of the Effect of a Dietary Fatty Acid Supplementation on Symptoms and Bronchial Inflammation in Patients With Asthma and House Dust Mite Allergy After Repeated Allergen Challenge
The proposed study will investigate the effect of a polyunsaturated fatty acid / lipid mixture (LCPUFAs) on the clinical symptoms, bronchial inflammation and lung function in allergic asthma in a bronchial allergen provocation (BAP) model. For this purpose, patients with stable episodic asthma and dust mite allergy will underwent BAP before and after supplementation with LCPUFAs. The clinical symptoms, bronchial inflammation, exhaled NO increase and lung function decline (FEV1) will be analyzed.
Read the detailed description
Asthma is a chronic lung disease, which is characterized by recurrent obstruction, a hypersensitivity and a chronic inflammation of the airway. It is known that LCPUVAs could reduce the production of inflammatory mediators. In addition, LCPUVAs can improve pulmonary function, with a concurrent reduction in bronchodilator use in patients with asthma. Subjects suffering from episodic asthma and house dust mite (HDM) allergy usually have a normal lung function testing at rest and show a decrease in lung function when they are exposed to HDM. Bronchial allergen provocation models are well established in asthma research and allow the evaluation of anti-allergic and anti-asthmatic agents in relatively small sample sizes. In a previous study the investigators could show, that LCPUVAs could reduce exhaled NO after repeated BAP with HDM.
In this study the investigators will investigate the protective effect of LCPUVAs in a repeated BAP model. Clinical symptoms (nasal and bronchial), exhaled NO, decrease in lung function the early asthmatic reaction (EAR), the late asthmatic reaction (LAR) and blood parameters (Triglyceride and Cholesterin and mircro RNAs) will be measured before and after LCPUVA supplementation.
- Conditions
- Allergic Asthma, Allergy to House Dust Mite
- Being tested
- Bronchial allergen provocation (BAP), Nasal provocation test (NPT), Methacholine test, Peak nasal expiratory flow (PNIF)
- Keywords
- allergic asthma,, house dust mite allergy, bronchial allergen provocation, LCPUFAs
- Medical subject headings
- Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchial allergen provocation (BAP)Diagnostic test
Nebulized Dermatophagoides farina administered at following doses: 10AE, 20 AE, 40 AE, 80 160 AE, etc… until the FEV1 decreases 20% below the initial FEV1-value
Nasal provocation test (NPT)Diagnostic test
Dermatophagoides farina will be administered in both nostrils
Methacholine testDiagnostic test
Nebulized metacholine will be administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg until the FEV1 decreases 20% below the initial FEV1-value
Peak nasal expiratory flow (PNIF)Diagnostic test
Comparison of peak nasal expiratory flow (PNIF) after NPT between groups
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo comparator 20 patients aged 18-45 years with a diagnosis of HDM induced allergic asthma and an increase of exhaled NO of 30% after BAP will be randomized to the Placebo Comparator Receives: Diagnostic Test: Bronchial allergen provocation (BAP); Diagnostic Test: Nasal provocation test (NPT); Diagnostic Test: Methacholine test; Diagnostic Test: Peak nasal expiratory flow (PNIF) |
| Verum | Active comparator | PUFAS: 2640 mg of middle-chain and polyunsaturated fatty acids 20 patients aged 18-45 years with a diagnosis of HDM induced allergic asthma and an increase of exhaled NO of 30% after BAP will be randomized to the Active Comparator Receives: Diagnostic Test: Bronchial allergen provocation (BAP); Diagnostic Test: Nasal provocation test (NPT); Diagnostic Test: Methacholine test; Diagnostic Test: Peak nasal expiratory flow (PNIF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrase of exhaled NO (eNO) after BAP
After BAP with HDM the decrease of eNO will be compared between placebo and active comparator. A relevant decrease is defined as a drop of 30% of exhaled NO.
Measured: 4 weeks
Secondary outcomes (11)
Absolute levels eNO
Comparison of absolute levels eNO (ppb)at end of treatment between groups
Measured: 4 weeks
Magnitude of EAR
Comparison of EAR (maximum decrease of FEV1) at end of treatment between groups
Measured: 4 weeks
Magnitude of LAR
Comparison of LAR (maximum decrease of FEV1 in %) at end of treatment between groups
Measured: 4 weeks
FEV1 after BAP
Comparison of FEV1 Levels 24 hours after BAP between groups
Measured: 4 weeks
Comparison of methacholin levels
Comparison of methacholin (mg) Levels 24 hours after BAP between groups
Measured: 4 weeks
Asthma control test (ACT)
Comparison of ACT score between Groups at end of treatment
Measured: 4 weeks
Cumulative Salbutamol use
Cumulative Salbutamol use in the last 4 days of treatment during repetitive BAP between groups
Measured: 4 days
Lebel symptom score
Comparison of Lebel symptom score after nasal provocation test (NPT), before and after supplementation between groups. A lebel score of 0-4 is negative, a lebel score >5 positive, the maximum result is 12.
Measured: 4 weeks
Peak nasal expiratory flow
Comparison of peak nasal expiratory flow (PNIF) after NPT between groups
Measured: 4 weeks
Visual analog scala (VAS)-score after NPT
Comparison of VAS (mm) after NPT between groups
Measured: 4 weeks
Visual analog scala (VAS)-score for nasal symptoms
Comparison of cumulative VAS-score for 4 nasal symptoms (Total mm each symptom) in the last 5 days of treatment during repetitive BAP between groups
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled prospective study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stefan Zielen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefan Zielen, Johann Wolfgang Goethe University Hospital
- Investigators
- Stefan Zielen, Professor, Principal investigator, Klinik für Kinder- und Jugendmedizin Universitätsklinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109534
- Sponsor's protocol ID
- 19-263
- Acronym
- LCPUFA
- Status last verified
- Sep 2019
- First submitted
- 27 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be provided of the investigated cohort
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of a Dietary Fatty Acid Supplementation on Symptoms and Bronchial Inflammation in Patients With Asthma and House Dust Mite Allergy After Repeated Allergen Challenge
- ClinicalTrials.gov ID
- NCT04109534
- Acronym / sponsor ID
- LCPUFA / 19-263
- Conditions
- Allergic Asthma, Allergy to House Dust Mite
- Keywords
- allergic asthma,, house dust mite allergy, bronchial allergen provocation, LCPUFAs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Stefan ZielenUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 30 Sep 2019 (actual)
- 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 proposed study will investigate the effect of a polyunsaturated fatty acid / lipid mixture (LCPUFAs) on the clinical symptoms, bronchial inflammation and lung function in allergic asthma in a bronchial allergen provocation (BAP) model. For this purpose, patients with stable episodic asthma and dust mite allergy will underwent BAP before and after supplementation with LCPUFAs. The clinical symptoms, bronchial inflammation, exhaled NO increase and lung function decline (FEV1) will be analyzed.
Detailed description
Asthma is a chronic lung disease, which is characterized by recurrent obstruction, a hypersensitivity and a chronic inflammation of the airway. It is known that LCPUVAs could reduce the production of inflammatory mediators. In addition, LCPUVAs can improve pulmonary function, with a concurrent reduction in bronchodilator use in patients with asthma. Subjects suffering from episodic asthma and house dust mite (HDM) allergy usually have a normal lung function testing at rest and show a decrease in lung function when they are exposed to HDM. Bronchial allergen provocation models are well established in asthma research and allow the evaluation of anti-allergic and anti-asthmatic agents in relatively small sample sizes. In a previous study the investigators could show, that LCPUVAs could reduce exhaled NO after repeated BAP with HDM.
In this study the investigators will investigate the protective effect of LCPUVAs in a repeated BAP model. Clinical symptoms (nasal and bronchial), exhaled NO, decrease in lung function the early asthmatic reaction (EAR), the late asthmatic reaction (LAR) and blood parameters (Triglyceride and Cholesterin and mircro RNAs) will be measured before and after LCPUVA supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Placebo-controlled prospective study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Diagnostic Test: Bronchial allergen provocation (BAP), Diagnostic Test: Nasal provocation test (NPT), Diagnostic Test: Methacholine test, Diagnostic Test: Peak nasal expiratory flow (PNIF)Placebo comparator 20 patients aged 18-45 years with a diagnosis of HDM induced allergic asthma and an increase of exhaled NO of 30% after BAP will be randomized to the Placebo Comparator |
| Verum | Active comparator | Diagnostic Test: Bronchial allergen provocation (BAP), Diagnostic Test: Nasal provocation test (NPT), Diagnostic Test: Methacholine test, Diagnostic Test: Peak nasal expiratory flow (PNIF)PUFAS: 2640 mg of middle-chain and polyunsaturated fatty acids 20 patients aged 18-45 years with a diagnosis of HDM induced allergic asthma and an increase of exhaled NO of 30% after BAP will be randomized to the Active Comparator |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed consent
Key exclusion criteria (8 listed)
- lung function Forced vital capacity (FVC) <80% and Forced expiratory volume in 1 second (FEV1) <75%
- 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 |
|---|---|---|
| Bronchial allergen provocation (BAP)Nebulized Dermatophagoides farina administered at following doses: 10AE, 20 AE, 40 AE, 80 160 AE, etc… until the FEV1 decreases 20% below the initial FEV1-value | Diagnostic test | Placebo, Verum |
| Nasal provocation test (NPT)Dermatophagoides farina will be administered in both nostrils | Diagnostic test | Placebo, Verum |
| Methacholine testNebulized metacholine will be administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg until the FEV1 decreases 20% below the initial FEV1-value | Diagnostic test | Placebo, Verum |
| Peak nasal expiratory flow (PNIF)Comparison of peak nasal expiratory flow (PNIF) after NPT between groups | Diagnostic test | Placebo, Verum |
Primary outcome
Decrase of exhaled NO (eNO) after BAP
Time frame: 4 weeks
After BAP with HDM the decrease of eNO will be compared between placebo and active comparator. A relevant decrease is defined as a drop of 30% of exhaled NO.
11 secondary outcomes
Absolute levels eNO
Time frame: 4 weeks
Magnitude of EAR
Time frame: 4 weeks
Magnitude of LAR
Time frame: 4 weeks
FEV1 after BAP
Time frame: 4 weeks
Comparison of methacholin levels
Time frame: 4 weeks
Asthma control test (ACT)
Time frame: 4 weeks
Cumulative Salbutamol use
Time frame: 4 days
Lebel symptom score
Time frame: 4 weeks
Peak nasal expiratory flow
Time frame: 4 weeks
Visual analog scala (VAS)-score after NPT
Time frame: 4 weeks
Visual analog scala (VAS)-score for nasal symptoms
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Individual participant dataSharing planned: Yes. Anonymized data will be provided of the investigated cohort
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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.
Stefan Zielen, Professor principal investigator
Klinik für Kinder- und Jugendmedizin Universitätsklinikum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchial allergen provocation (BAP), Nasal provocation test (NPT) and Methacholine test in people with Allergic Asthma and Allergy to House Dust Mite, run by Stefan Zielen 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 6 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: status not confirmed, as of the sponsor's last update on 1 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Zielen, Professor (+496301 ext. 83349, Stefan.Zielen@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrase of exhaled NO (eNO) after BAP (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2019.