Aspirin-exacerbated Respiratory DiseaseAERDNCT03973749
Effects of a High or Low Salycilate Diet on Urinary LTE4 and Clinical Features in AERD
A study testing Low salycilate diet in people with Aspirin-exacerbated Respiratory Disease and Aspirin-Sensitive Asthma With Nasal Polyps, run by Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.
Trial summary
On day one, two groups of nine patients each will respectively recieve the tree daily meals (breakfast, Lunch and dinner) in a controled clinical setting. Group 1 will recieve a low-salycilate diet, and group 2 a high-salycilate diet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspirin-exacerbated Respiratory Disease, Aspirin-Sensitive Asthma With Nasal Polyps, Samter's Syndrome
- What is being tested?
- Low salycilate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteMexico
- Study dates
- 2 Feb 2017to 31 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed Aspirin exacerbated respiratory disease.
- Controled asthma
- No actual systemic corticosteroid treatment
- No antileucotriene treatment.
Who cannot join
- Patients who do not complete both phases of the study
- Patients unable to perform adecuate spyrometric testing
- Patients who present severe asthmatic reactions with high salycilate foods
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Enfermedades Respiratorias
Mexico City, Mexico City, 14080
About this study
Official title: Effects of a High or Low Salycilate Diet on Urinary Leucotriene E4 Levels and Clinical Features in Patients With Aspirin Exacerbated Respiratory Disease
On day one, two groups of nine patients each will respectively recieve the tree daily meals (breakfast, Lunch and dinner) in a controled clinical setting. Group 1 will recieve a low-salycilate diet, and group 2 a high-salycilate diet. Two hours after each meal, urinary Leucotriene E4, FEV1, FVC, FEV1/FVC and total nasal resistance will be measured. On day 7, after clearance time, group 1 will recieve high-salycilate diet and group 2 low salycilate diet and the same measurements will be obtained.
- Conditions
- Aspirin-exacerbated Respiratory Disease, Aspirin-Sensitive Asthma With Nasal Polyps, Samter's Syndrome, Widal Syndrome
- Being tested
- Low salycilate diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low salycilate dietOther
Also called High salycilate diet
Each arm of the experimental group will be exposed to low and high concentrations of dietary salycilates and urinary LTE4, FEV1, FVC, FEV1/FVC and total inspiratory nasal resistance will be measured at basal level and then two hours after each of the 3 daily meals.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Low salycilate diet on day one and High salycilate diet on day 7 Receives: Other: Low salycilate diet |
| Group 2 | Experimental | High salycilate diet on day one and Low salycilate diet on day 7 Receives: Other: Low salycilate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Urinary concentration of Leucotriene E4 (LTE4)
pg/ml of creatinine
Measured: Baseline-4-8-12 hours in day one and Baseline-4-8-12 hours in day 7
Secondary outcomes (4)
Change from baseline in Expiratory Volume in 1 second (FEV-1)
Percentage of referenced value
Measured: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
Change from baseline in Vital Capacity (FVC)
Percentage of referenced value
Measured: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
Change from baseline in the Relationship between FEV1/FVC
Percentage of referenced value
Measured: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
Change from baseline in the total nasal resistance obtained by rhinometry
pascals/cm3/sec
Measured: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start2 Feb 2017
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspirin-exacerbated Respiratory DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Enfermedades Respiratorias
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marcos Alejandro Jimenez Chobillon, Instituto Nacional de Enfermedades Respiratorias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973749
- Sponsor's protocol ID
- C13-17
- Acronym
- AERD
- Status last verified
- Jun 2019
- First submitted
- 6 Feb 2019
- Last updated
- 4 Jun 2019
- 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 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a High or Low Salycilate Diet on Urinary Leucotriene E4 Levels and Clinical Features in Patients With Aspirin Exacerbated Respiratory Disease
- ClinicalTrials.gov ID
- NCT03973749
- Acronym / sponsor ID
- AERD / C13-17
- Conditions
- Aspirin-exacerbated Respiratory Disease, Aspirin-Sensitive Asthma With Nasal Polyps, Samter's Syndrome, Widal Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Instituto Nacional de Enfermedades RespiratoriasOther government
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 4 Jun 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.
On day one, two groups of nine patients each will respectively recieve the tree daily meals (breakfast, Lunch and dinner) in a controled clinical setting. Group 1 will recieve a low-salycilate diet, and group 2 a high-salycilate diet. Two hours after each meal, urinary Leucotriene E4, FEV1, FVC, FEV1/FVC and total nasal resistance will be measured. On day 7, after clearance time, group 1 will recieve high-salycilate diet and group 2 low salycilate diet and the same measurements will be obtained.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Low salycilate dietLow salycilate diet on day one and High salycilate diet on day 7 |
| Group 2 | Experimental | Other: Low salycilate dietHigh salycilate diet on day one and Low salycilate diet on day 7 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed Aspirin exacerbated respiratory disease.
- Controled asthma
- No actual systemic corticosteroid treatment
- No antileucotriene treatment.
Key exclusion criteria (3 listed)
- Patients who do not complete both phases of the study
- Patients unable to perform adecuate spyrometric testing
- Patients who present severe asthmatic reactions with high salycilate foods
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 |
|---|---|---|
| Low salycilate dietAlso: High salycilate dietEach arm of the experimental group will be exposed to low and high concentrations of dietary salycilates and urinary LTE4, FEV1, FVC, FEV1/FVC and total inspiratory nasal resistance will be measured at basal level and then two hours after each of the 3 daily meals. | Other | Group 1, Group 2 |
Primary outcome
Change from baseline in Urinary concentration of Leucotriene E4 (LTE4)
Time frame: Baseline-4-8-12 hours in day one and Baseline-4-8-12 hours in day 7
pg/ml of creatinine
4 secondary outcomes
Change from baseline in Expiratory Volume in 1 second (FEV-1)
Time frame: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
Change from baseline in Vital Capacity (FVC)
Time frame: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
Change from baseline in the Relationship between FEV1/FVC
Time frame: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
Change from baseline in the total nasal resistance obtained by rhinometry
Time frame: Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Aspirin-exacerbated Respiratory Disease
Active, not recruitingPhase 2
Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease
Nasal Polyps, Asthma, Aspirin-Induced
RecruitingObservational study
Prospective Registry of Eosinophilia With Respiratory Manifestations With Translational Research Identifying and Characterizing Eosinophils
Eosinophilic Asthma, EGPA - Eosinophilic Granulomatosis With Polyangiitis
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 Low salycilate diet in people with Aspirin-exacerbated Respiratory Disease and Aspirin-Sensitive Asthma With Nasal Polyps, run by Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.
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 4 inclusion and 3 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 4 Jun 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 Mexico. 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?
Results are not available in the source record.
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?
Change from baseline in Urinary concentration of Leucotriene E4 (LTE4) (time frame: Baseline-4-8-12 hours in day one and Baseline-4-8-12 hours in day 7). 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 4 Jun 2019.