Asthma, Aspirin-InducedPhase 2AspirinNCT01597375
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease (Aspirin)
A Phase 2 study testing Prasugrel Oral Tablet in people with Asthma, Aspirin-Induced and Aspirin Exacerbated Asthma, run by Elliot Israel, MD at 1 site in United States.
Trial summary
The investigators are doing this research study to find out if giving a drug called prasugrel, which is used to prevent blood clots, can reduce reactions to aspirin in people with aspirin exacerbated respiratory disease (AERD), and to learn why taking aspirin every day can work as a treatment for people with AERD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma, Aspirin-Induced, Aspirin Exacerbated Asthma
- What is being tested?
- Prasugrel Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2012to 14 Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- History of physician-diagnosed asthma
- History of nasal polyposis
- History of at least one clinical reaction to oral aspirin or other nonselective COX inhibitor with features of both lower (cough, chest tightness, wheezing, dyspnea) and upper (rhinorrhea, sneezing, nasal obstruction, conjunctival itching and discharge) airway involvement.
- Stable asthma (post-bronchodilator FEV1 of 70% or better, no increase in baseline dose of oral glucocorticoids for at least 3 months, and no history of hospitalization or emergency room visits for asthma for at least the prior 6 months).
- No current smoking, defined as no daily tobacco smoking for at least 6 months and not more than one instance of tobacco smoking in the last 3 months.
- Non-pregnant
Show all 23Show fewer
- Only those individuals who would otherwise meet clinical qualifications for aspirin desensitization and treatment with high-dose aspirin will be considered for enrollment in the study.
- Inclusion Criteria for Participants who are Aspirin Tolerant Asthmatics:
- History of physician-diagnosed asthma.
- No current nasal polyposis confirmed by nasal examination.
- No history of any adverse reaction to aspirin or a COX inhibitor.
- Stable asthma (post-bronchodilator FEV1 of 70% or better, no increase in baseline dose of oral glucocorticoids for at least 3 months, and no history of hospitalization or emergency room visits for asthma for at least the prior 6 months).
- No current smoking
- Non-pregnant
- Inclusion Criteria for Non Asthmatics with Allergic Rhinitis:
- No history of physician-diagnosed asthma.
- No current nasal polyposis confirmed by nasal examination.
- No history of any adverse reaction to aspirin or a COX inhibitor.
- No current smoking
- Non-pregnant
- Clinical history of symptoms consistent with allergic rhinitis and previously documented allergy to at least one environmental,immunoglobulin E (IgE) testing).
- Normal lung function (baseline FEV1 of 80% of predicted or better).
- A score of 4 or below on the Asthma Screening Questionnaire (33) and negative responses to asthma history questions
Who cannot join
- Current breastfeeding
- History of bleeding diathesis or current use of anticoagulant or antiplatelet drugs
- Hypersensitivity to montelukast or thienopyridines
- History of peptic ulcer disease or gastrointestinal bleed
- Current severe gastro-esophageal reflux disease (GERD), defined as patient currently requiring more than 2 total doses of medication per day to treat persistent symptoms: either more than 2 doses of any single medication type (antacid, proton pump inhibitor, or H2 receptor antagonist), or more than 2 types of medication per day to treat symptoms
- History of systemic or life-threatening respiratory reaction to aspirin requiring intubation or administration of adrenalin
Show all 17Show fewer
- Current use of any oral beta blocker (due to the risk of bronchospasm associated with beta blockers).
- History of transient ischemic attack or stroke, or diabetes.
- Current presence of uncontrolled hypertension.
- History of hepatic impairment or alcoholism, or evidence of abnormal liver function at Screening Visit. Aspartate transaminase (AST) and alanine transaminase (ALT) levels may not exceed 1.5x the upper limit of normal at Screening Visit (AST may not exceed 52 IU/L, ALT may not exceed 78 IU/L).
- Exclusion Criteria for Participants with Aspirin Tolerant Asthma and Non Asthmatics with Allergic Rhinitis:
- Current breastfeeding
- History of bleeding diathesis or current use of anticoagulant or antiplatelet drugs
- Hypersensitivity to montelukast or thienopyridines
- History of peptic ulcer disease or gastrointestinal bleed
- Current severe GERD
- Current use of any oral beta blocker.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are doing this research study to find out if giving a drug called prasugrel, which is used to prevent blood clots, can reduce reactions to aspirin in people with aspirin exacerbated respiratory disease (AERD), and to learn why taking aspirin every day can work as a treatment for people with AERD. People with AERD have symptoms of asthma, severe runny nose, polyps in the nose, and develop allergic reactions if they take medications like aspirin.
People with AERD can be desensitized to aspirin in order to be able to safely use it daily, but the investigators do not know if prasugrel may prevent reactions to aspirin and provide a safer way for people with AERD to tolerate aspirin.
The investigators also want to understand what is different about the cells and urine from subjects who have AERD, in comparison to subjects who have asthma but do not have AERD and subjects who have allergic rhinitis but do not have asthma. Lastly, the investigators want to understand how aspirin acts differently in subjects who have AERD, in comparison to subjects who have asthma but do not have AERD.
- Being tested
- Placebo Oral Tablet, Prasugrel Oral Tablet
- Keywords
- Aspirin, Prasugrel, Asthma, AERD, Aspirin challenge, Aspirin desensitization, Aspirin induced asthma
- Medical subject headings
- Asthma, Aspirin-Induced, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Oral TabletDrug
Also called Placebo
Participants will take a 60 mg loading dose. After they will take 10 mg by mouth daily if they weigh >60kg or 5 mg by mouth daily if they weigh <60 kg. They will take the drug for 4 weeks prior to the aspirin challenge/desensitization.
Prasugrel Oral TabletDrug
Also called Effient
Participants will take a 60 mg loading dose. After they will take 10 mg by mouth daily if they weigh >60kg or 5 mg by mouth daily if they weigh <60 kg. They will take the drug for 4 weeks prior to the aspirin challenge/desensitization.
| Study group | Role | What they receive |
|---|---|---|
| Placebo then Prasugrel | Experimental | Subjects with AERD first received placebo oral tablet for 4 weeks prior to their aspirin challenge/desensitization. After aspirin challenge/desensitization subjects were discharged to home to washout the study drug from the first treatment phase. At the end of the 2-week washout period, subjects crossed over to the alternate treatment for 4 weeks of Prasugrel oral tablets [ (5 mg (for patients <60kg) or 10mg (> 60kg) daily, following a 60mg loading dose)] and returned for the second aspirin challenge.
Because no period effect was observed, data obtained from all subjects while on placebo from either visit 2 or 3 were combined. Receives: Drug: Placebo Oral Tablet; Drug: Prasugrel Oral Tablet |
| Prasugrel then Placebo | Experimental | Subjects with AERD first received prasugrel oral tablets [ (5 mg (for patients <60kg) or 10mg (> 60kg) daily, following a 60mg loading dose)] prior to their aspirin challenge/desensitization. After aspirin challenge/desensitization subjects were discharged to home to washout the study drug from the first treatment phase. At the end of the 2-week washout period, subjects crossed over to the alternate treatment for 4 weeks of Placebo oral tablet.
Because no period effect was observed, data obtained from all subjects while on Prasugrel from either visit 2 or 3 were combined. Receives: Drug: Placebo Oral Tablet; Drug: Prasugrel Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in PD2 (Provocative Dose of Aspirin That Elicits an Increase in Nasal Symptom Score of 2 During an Aspirin Challenge) on Prasugrel Versus Placebo
The PD2 is the provocative dose of aspirin that elicits an increase in nasal symptom score of 2 during an aspirin challenge. The PD2 is calculated by:
inverse〖log〗_10 (((2-(PrevTNSS-BaselineTNSS))×(〖log〗_10 ProvocDose-〖log〗_10 PrevDose))/((MaxTNSS-BaselineTNSS)-(PrevTNSS-BaselineTNSS) )+(〖log〗_10 PrevDose))
Measured: Difference in PD2 (provocative dose of aspirin that elicits an increase in nasal symptom score of 2 during an aspirin challenge) between Visits 2 and 3 (weeks 8 and 14), calculated at visit 3
Change From Baseline Expression Levels of COX-2 Transcript and Protein in Peripheral Blood Leukocytes of Subjects With AERD After 8 Weeks of Treatment With Aspirin.
This study will compare this outcome within each participant between baseline (established at Visit 1, prior to initiation of prasugrel therapy) and at the completion of 8 weeks of aspirin therapy.
Measured: Evaluated at visits 1 and 4 (weeks 4 and 22)
Secondary outcomes (6)
Difference in Participant's Provocative Dose of Aspirin When Pretreated With Prasugrel Versus Placebo
We will monitor the dose of aspirin at which the participant shows symptoms (increased discomfort, 15% drop in FEV1) during the aspirin challenge/desensitization. We will compare the provocative aspirin dose obtained from the aspirin challenge occurring after pretreatment with prasugrel to the dose obtained after pretreatment with placebo.
Measured: Evaluated at visits 2 and 3 (weeks 8 and 14)
Change in Total Nasal Symptom Score(TNSS)From Baseline to Peak During Aspirin Challenge on Placebo Versus Prasugrel.
The primary outcome in Part 1 will be the maximum Total Nasal Symptom Score (TNSS) attained for subjects with AERD during the clinical reaction to aspirin challenge. The primary analysis will compare this outcome within each participant after treatment with prasugrel versus placebo. Nasal symptoms including congestion, rhinorrhea, runny nose, itchy nose, sneezing, itchy eyes, teary eyes, itchy ears/throat, and eye redness were assessed on a 0- to 5-point scale (0, none-5, very severe) in response to the provocative dose of aspirin during aspirin challenge/desensitization and summed together to generate the TNSS score (range 0-40).
Measured: Data obtained at visits 2 and 3 (weeks 8 and 14) and change calculated at visit 3
Change in Urinary LTE4 During Aspirin Challenge on Placebo Versus Prasugrel
We will compare the participant's Leukotriene E4 (LTE4) obtained from the aspirin challenge done after pretreatment with prasugrel, the aspirin challenge done after pretreatment with placebo.
Measured: Change from visits 2 at visit 3 (weeks 8, 14), calculated and reported at visit 3
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Measurement After Aspirin Desensitization and High Dose Aspirin Treatment at 8 Weeks
We will note difference in the fractional exhaled nitric oxide (FeNO) obtained before any treatment ( baseline ) and after one day Aspirin desensitization followed by 8 weeks Aspirin treatment ( 650 mg oral aspirin tablet twice daily )
Measured: Evaluated at baseline and reported at 8 weeks
Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Score After Aspirin Desensitization and High Dose Aspirin Treatment at 8 Weeks
We will note difference in the Asthma Control Questionnaire-7 (ACQ-7) score [ The ACQ has 7 questions on a 7-point scale (minimum score of 0=no impairment, maximum score of 6= maximum impairment)] obtained before any treatment ( baseline ) and after one day Aspirin desensitization followed by 8 weeks Aspirin treatment ( 650 mg oral aspirin tablet twice daily )
Measured: Evaluated at baseline and reported at 8 weeks
Change From Baseline in Prostaglandin Metabolites (PGD-M) Measurement After Aspirin Desensitization and High Dose Aspirin Treatment at 8 Weeks
We will note difference in the Prostaglandin metabolites (PGD-M) measurement obtained before any treatment ( baseline ) and after one day Aspirin desensitization followed by 8 weeks Aspirin treatment ( 650 mg oral aspirin tablet twice daily )
Measured: Evaluated at baseline and reported at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study start31 Aug 2012
- Primary completion14 Dec 2016
- Study completion14 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Asthma, Aspirin-InducedStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elliot Israel, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Sponsor-investigator, Elliot Israel, MD, Brigham and Women's Hospital
- Investigators
- Elliot Israel, MD, Principal investigator, Brigham and Women's HospitalJoshua Boyce, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597375
- Sponsor's protocol ID
- 2010P002961
- Acronym
- Aspirin
- Status last verified
- Sep 2019
- First submitted
- 30 Apr 2012
- Last updated
- 19 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Control of Aspirin-Exacerbated Respiratory Disease (Aspirin)
- ClinicalTrials.gov ID
- NCT01597375
- Acronym / sponsor ID
- Aspirin / 2010P002961
- Keywords
- Aspirin, Prasugrel, Asthma, AERD, Aspirin challenge, Aspirin desensitization, Aspirin induced asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Elliot Israel, MDUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 31 Aug 2012 (actual)
- Primary completion
- 14 Dec 2016 (actual)
- Study completion
- 14 Dec 2016 (actual)
- First posted
- 14 May 2012 (estimated)
- Results
- Posted 24 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are doing this research study to find out if giving a drug called prasugrel, which is used to prevent blood clots, can reduce reactions to aspirin in people with aspirin exacerbated respiratory disease (AERD), and to learn why taking aspirin every day can work as a treatment for people with AERD. People with AERD have symptoms of asthma, severe runny nose, polyps in the nose, and develop allergic reactions if they take medications like aspirin.
People with AERD can be desensitized to aspirin in order to be able to safely use it daily, but the investigators do not know if prasugrel may prevent reactions to aspirin and provide a safer way for people with AERD to tolerate aspirin.
The investigators also want to understand what is different about the cells and urine from subjects who have AERD, in comparison to subjects who have asthma but do not have AERD and subjects who have allergic rhinitis but do not have asthma. Lastly, the investigators want to understand how aspirin acts differently in subjects who have AERD, in comparison to subjects who have asthma but do not have AERD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo then Prasugrel | Experimental | Drug: Placebo Oral Tablet, Drug: Prasugrel Oral TabletSubjects with AERD first received placebo oral tablet for 4 weeks prior to their aspirin challenge/desensitization. After aspirin challenge/desensitization subjects were discharged to home to washout the study drug from the first treatment phase. At the end of the 2-week washout period, subjects crossed over to the alternate treatment for 4 weeks of Prasugrel oral tablets [ (5 mg (for patients <60kg) or 10mg (> 60kg) daily, following a 60mg loading dose)] and returned for the second aspirin challenge. Because no period effect was observed, data obtained from all subjects while on placebo from either visit 2 or 3 were combined. |
| Prasugrel then Placebo | Experimental | Drug: Placebo Oral Tablet, Drug: Prasugrel Oral TabletSubjects with AERD first received prasugrel oral tablets [ (5 mg (for patients <60kg) or 10mg (> 60kg) daily, following a 60mg loading dose)] prior to their aspirin challenge/desensitization. After aspirin challenge/desensitization subjects were discharged to home to washout the study drug from the first treatment phase. At the end of the 2-week washout period, subjects crossed over to the alternate treatment for 4 weeks of Placebo oral tablet. Because no period effect was observed, data obtained from all subjects while on Prasugrel from either visit 2 or 3 were combined. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- History of physician-diagnosed asthma
- History of nasal polyposis
- History of at least one clinical reaction to oral aspirin or other nonselective COX inhibitor with features of both lower (cough, chest tightness, wheezing, dyspnea) and upper (rhinorrhea, sneezing, nasal obstruction, conjunctival itching and discharge) airway involvement.
- Stable asthma (post-bronchodilator FEV1 of 70% or better, no increase in baseline dose of oral glucocorticoids for at least 3 months, and no history of hospitalization or emergency room visits for asthma for at least the prior 6 months).
- No current smoking, defined as no daily tobacco smoking for at least 6 months and not more than one instance of tobacco smoking in the last 3 months.
Key exclusion criteria (17 listed)
- Current breastfeeding
- History of bleeding diathesis or current use of anticoagulant or antiplatelet drugs
- Hypersensitivity to montelukast or thienopyridines
- History of peptic ulcer disease or gastrointestinal bleed
- Current severe gastro-esophageal reflux disease (GERD), defined as patient currently requiring more than 2 total doses of medication per day to treat persistent symptoms: either more than 2 doses of any single medication type (antacid, proton pump inhibitor, or H2 receptor antagonist), or more than 2 types of medication per day to treat symptoms
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 |
|---|---|---|
| Placebo Oral TabletAlso: PlaceboParticipants will take a 60 mg loading dose. After they will take 10 mg by mouth daily if they weigh >60kg or 5 mg by mouth daily if they weigh <60 kg. They will take the drug for 4 weeks prior to the aspirin challenge/desensitization. | Drug | Placebo then Prasugrel, Prasugrel then Placebo |
| Prasugrel Oral TabletAlso: EffientParticipants will take a 60 mg loading dose. After they will take 10 mg by mouth daily if they weigh >60kg or 5 mg by mouth daily if they weigh <60 kg. They will take the drug for 4 weeks prior to the aspirin challenge/desensitization. | Drug | Placebo then Prasugrel, Prasugrel then Placebo |
Primary outcome
Difference in PD2 (Provocative Dose of Aspirin That Elicits an Increase in Nasal Symptom Score of 2 During an Aspirin Challenge) on Prasugrel Versus Placebo
Time frame: Difference in PD2 (provocative dose of aspirin that elicits an increase in nasal symptom score of 2 during an aspirin challenge) between Visits 2 and 3 (weeks 8 and 14), calculated at visit 3
The PD2 is the provocative dose of aspirin that elicits an increase in nasal symptom score of 2 during an aspirin challenge. The PD2 is calculated by: inverse〖log〗_10 (((2-(PrevTNSS-BaselineTNSS))×(〖log〗_10 ProvocDose-〖log〗_10 PrevDose))/((MaxTNSS-BaselineTNSS)-(PrevTNSS-BaselineTNSS) )+(〖log〗_10 PrevDose))
Change From Baseline Expression Levels of COX-2 Transcript and Protein in Peripheral Blood Leukocytes of Subjects With AERD After 8 Weeks of Treatment With Aspirin.
Time frame: Evaluated at visits 1 and 4 (weeks 4 and 22)
This study will compare this outcome within each participant between baseline (established at Visit 1, prior to initiation of prasugrel therapy) and at the completion of 8 weeks of aspirin therapy.
6 secondary outcomes
Difference in Participant's Provocative Dose of Aspirin When Pretreated With Prasugrel Versus Placebo
Time frame: Evaluated at visits 2 and 3 (weeks 8 and 14)
Change in Total Nasal Symptom Score(TNSS)From Baseline to Peak During Aspirin Challenge on Placebo Versus Prasugrel.
Time frame: Data obtained at visits 2 and 3 (weeks 8 and 14) and change calculated at visit 3
Change in Urinary LTE4 During Aspirin Challenge on Placebo Versus Prasugrel
Time frame: Change from visits 2 at visit 3 (weeks 8, 14), calculated and reported at visit 3
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Measurement After Aspirin Desensitization and High Dose Aspirin Treatment at 8 Weeks
Time frame: Evaluated at baseline and reported at 8 weeks
Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Score After Aspirin Desensitization and High Dose Aspirin Treatment at 8 Weeks
Time frame: Evaluated at baseline and reported at 8 weeks
Change From Baseline in Prostaglandin Metabolites (PGD-M) Measurement After Aspirin Desensitization and High Dose Aspirin Treatment at 8 Weeks
Time frame: Evaluated at baseline and reported at 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Asthma, Aspirin-Induced
Active, not recruitingPhase 2
Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease
Nasal Polyps, Asthma, Aspirin-Induced
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.
Elliot Israel, MD principal investigator
Brigham and Women's Hospital
Joshua Boyce, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prasugrel Oral Tablet in people with Asthma, Aspirin-Induced and Aspirin Exacerbated Asthma, run by Elliot Israel, MD at 1 site in United States.
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 23 inclusion and 17 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 19 Sep 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in PD2 (Provocative Dose of Aspirin That Elicits an Increase in Nasal Symptom Score of 2 During an Aspirin Challenge) on Prasugrel Versus Placebo (time frame: Difference in PD2 (provocative dose of aspirin that elicits an increase in nasal symptom score of 2 during an aspirin challenge) between Visits 2 and 3 (weeks 8 and 14), calculated at visit 3). 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 19 Sep 2019.