Atopic Asthma18-03 EONOVNCT03665701
Characterization of the Inhibitory Effects of Fevipiprant (QAW039) on Activation of Eosinophils and ILC2 Cells by Prostaglandin D2 Metabolites
A study testing Blood Sampling in people with Atopic Asthma, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
The aim of this study is to draw blood from patients with well-defined atopic asthma that will be subsequently used in invitro experiments to investigate the activation potency of Prostaglandin D2 metabolites to the DP2 receptor in comparison to Prostaglandin D2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Asthma
- What is being tested?
- Blood Sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteGermany
- Study dates
- 16 Aug 2018to 16 Dec 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women will be considered for inclusion if they are:
- Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit).
- Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- Body weight ≥ 50 kg and BMI within the range 19-32 kg/m²
- History of allergic asthma since at least 12 months
- A concentration of at least 0,15 x 106/mL eosinophils in peripheral blood
Who cannot join
- History of an acute infection two weeks prior to the screening visit.
- Intake of oral steroids within 4 weeks prior to screening
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Participation in another clinical trial 30 days prior to enrollment.
- Donation of more than 100 ml of blood in the preceding 2 months before the screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to draw blood from patients with well-defined atopic asthma that will be subsequently used in invitro experiments to investigate the activation potency of Prostaglandin D2 metabolites to the DP2 receptor in comparison to Prostaglandin D2. The inhibitory activity of a potent DP2 receptor antagonist, Fevipripant, shall be determined.
Read the detailed description
The inhibitory activity of a potent DP2 receptor antagonist shall be determined. For these experiments eosinophil granulocytes and ILC2 cells will be isolated from the collected blood samples and used in specific assays in respect to their functional reactivity against the DP2 receptor antagonist Fevipiprant after respective stimulation using Prostaglandin D2 metabolites or Prostaglandin D2. Major rationale is to show and determine the EC70 of the effectivity of Fevipiprant against Prostaglandin D2 metabolite triggered activation of eosinophil granulocytes and ILC2 innate lymphoid cells.
- Conditions
- Atopic Asthma
- Being tested
- Blood Sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SamplingProcedure or surgery
Blood samples used within in vitro experiments to investigate the activation potency of Prostaglandin D2 metabolites to the DP2 receptor in comparison to Prostaglandin D2.
| Study group | Role | What they receive |
|---|---|---|
| Inhibitory effects of Fevipiprant | Experimental | in vitro experiments: The reaction of the innate lymphoid cells by cytokine secretion in response to the stimulation by Prostagalandin D2 metabolites and the measurement of a potential suppressive effect of Fevipiprant will be assessed. Receives: Procedure: Blood Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokinesecretion without presence of Fevipiprant
Cytokine release after exposure of ILC2 cells to prostaglandin D2
Measured: 4 hours after in-vitro exposure of ILC2 cells to prostaglandin D2
Cytokinesecretion with presence of Fevipiprant
Cytokine release after exposure of ILC2 cells to prostaglandin D2
Measured: 4 hours after in-vitro exposure of ILC2 cells to prostaglandin D2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start16 Aug 2018
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665701
- Sponsor's protocol ID
- 18-03 EONOV
- Acronym
- 18-03 EONOV
- Status last verified
- Jun 2020
- First submitted
- 28 Aug 2018
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Inhibitory Effects of Fevipiprant (QAW039) on Activation of Eosinophils and ILC2 Cells by Prostaglandin D2 Metabolites
- ClinicalTrials.gov ID
- NCT03665701
- Acronym / sponsor ID
- 18-03 EONOV / 18-03 EONOV
- Conditions
- Atopic Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 11 Sep 2018 (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 aim of this study is to draw blood from patients with well-defined atopic asthma that will be subsequently used in invitro experiments to investigate the activation potency of Prostaglandin D2 metabolites to the DP2 receptor in comparison to Prostaglandin D2. The inhibitory activity of a potent DP2 receptor antagonist, Fevipripant, shall be determined.
Detailed description
The inhibitory activity of a potent DP2 receptor antagonist shall be determined. For these experiments eosinophil granulocytes and ILC2 cells will be isolated from the collected blood samples and used in specific assays in respect to their functional reactivity against the DP2 receptor antagonist Fevipiprant after respective stimulation using Prostaglandin D2 metabolites or Prostaglandin D2. Major rationale is to show and determine the EC70 of the effectivity of Fevipiprant against Prostaglandin D2 metabolite triggered activation of eosinophil granulocytes and ILC2 innate lymphoid cells.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhibitory effects of Fevipiprant | Experimental | Procedure: Blood Samplingin vitro experiments: The reaction of the innate lymphoid cells by cytokine secretion in response to the stimulation by Prostagalandin D2 metabolites and the measurement of a potential suppressive effect of Fevipiprant will be assessed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women will be considered for inclusion if they are:
- Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit).
- Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- Body weight ≥ 50 kg and BMI within the range 19-32 kg/m²
- History of allergic asthma since at least 12 months
Key exclusion criteria (5 listed)
- History of an acute infection two weeks prior to the screening visit.
- Intake of oral steroids within 4 weeks prior to screening
- Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- Participation in another clinical trial 30 days prior to enrollment.
- Donation of more than 100 ml of blood in the preceding 2 months before the screening visit.
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 |
|---|---|---|
| Blood SamplingBlood samples used within in vitro experiments to investigate the activation potency of Prostaglandin D2 metabolites to the DP2 receptor in comparison to Prostaglandin D2. | Procedure or surgery | Inhibitory effects of Fevipiprant |
Primary outcome
Cytokinesecretion without presence of Fevipiprant
Time frame: 4 hours after in-vitro exposure of ILC2 cells to prostaglandin D2
Cytokine release after exposure of ILC2 cells to prostaglandin D2
Cytokinesecretion with presence of Fevipiprant
Time frame: 4 hours after in-vitro exposure of ILC2 cells to prostaglandin D2
Cytokine release after exposure of ILC2 cells to prostaglandin D2
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 17 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Sampling in people with Atopic Asthma, run by Fraunhofer-Institute of Toxicology and Experimental Medicine 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 5 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 17 Jun 2020. 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. 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?
Cytokinesecretion without presence of Fevipiprant (time frame: 4 hours after in-vitro exposure of ILC2 cells to prostaglandin D2). The study lists 2 primary outcomes in all. 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 17 Jun 2020.