AsthmaPhase 2ALMANCT03680976
Anti-Inflammatory Lipid Mediators in Asthma
A Phase 2 study testing CXA-10 in people with Asthma, run by Sally E. Wenzel MD at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the efficacy and safety of 10-nitro-9(E)-octadec-9-enoic acid (CXA-10) in obese adult asthmatics. The study's hypothesis is that 150 mg/day of CXA-10 for 12 weeks will alleviate obesity-related airway hyper-reactivity in obese adult asthmatics. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- CXA-10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Apr 2021
- Phase
- Phase 2
- 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
- Adequate completion of informed consent process with written documentation. Male and female patients, 18 to 65 yrs old female subjects should be either post-menopausal, surgically sterile, or women of child-bearing potential (WOCP) with a negative pregnancy test prior to entering the study and who agree to use an acceptable method of contraception, for the duration of the study.
- Diagnosis of asthma: based on previous physician diagnosis for > 6 months, and either baseline pre-bronchodilator (BD) FEV1 between 50 and 90% predicted with a 12% or greater bronchodilator response to 4 puffs of albuterol or PC20 methacholine (16 mg) if no BD response (<12% change), within 2 years of Visit 0. If no historical reversibility or historical PC20, and the participant does not reverse 12% at V0, the participant can return for V0a to meet this eligibility criteria.
- Daily treatment with inhaled corticosteroids and long acting beta agonists (ICS/LABA) combination medication for at least 3 months; on a stable dose for the 4 weeks prior to Visit 0
- Asthma control questionnaire ACQ > 1.5 \& ≤ 3
- Smoking history <10 pack years and no smoking in the last year
- Body Mass Index (BMI) ≥ 30 kg/m2
Show all 11Show fewer
- Hemoglobin A1c (HbA1c) <8%
- Average systolic blood pressure <160 or diastolic < 100 mmHg (average of three measurements))
- Resting HR ≥45 beats per minute (BPM) after 5 minute rest at screening
- QTcF interval (Fredericia's correction factor) must be ≤430 msec at screening and pre-dose for males and ≤450 msec for females.
- For randomization: No exacerbations or treatment failures during the run in. Patients, who exacerbate or experience treatment failure during the run-in, may re-enroll 4 weeks after the exacerbation has resolved (completed course of systemic corticosteroids).
Who cannot join
- Respiratory tract infection within the last 4 weeks
- Oral or systemic corticosteroid burst within the last 4 weeks
- Asthma-related hospitalization within the last 2 months
- Three or more asthma exacerbations requiring treatment with systemic corticosteroids in the past year consistent with severe asthma
- Asthma-related ER visit within the previous 4 weeks
- Significant or uncontrolled concomitant medical illness including (but not limited to) heart disease, cancer, or diabetes at the discretion of the investigator
Show all 37Show fewer
- History of ICU admission/intubation due to asthma in the past year
- Current statins use, patients may stop and re-enroll after 4 weeks of stopping statins
- Positive pregnancy test at screening and at pre-dose
- Women who are breastfeeding
- Women of childbearing potential who are unwilling to use an acceptable method of birth control.
- Intolerance or hypersensitivity to the CXA-10 or it's excipients
- Treatment with any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of dosing (this includes investigational formulations of marketed products, inhaled and topical drugs
- Unable or unlikely to complete study assessments or the study intervention (i.e. bronchoscopy) poses undue risk to patient in the opinion of the Investigator;
- Any kind of oral nitrates such as nitroglycerin
- Any clinical history of cardiovascular events, arrhythmias, fainting, palpitations within the previous 3 years
- Personal or family history of congenital prolonged QT syndromes or sudden unexpected death due to a cardiac reason
- History of any primary malignancy, including a history of melanoma or suspicious undiagnosed skin lesions, with the exception of basal cell or squamous cell carcinomas of the skin
- Cervical carcinoma in situ or other malignancies curatively treated and with no evidence of disease for at least 5 years
- History of alcohol or drug abuse in the 6 month period prior to enrollment
- Treatment with vitamins, herbal and dietary supplements within 7 days or 5 - ½ lives whichever is longer prior to dosing until the final study visit, whichever is longer prior to dosing until the final study visit. (may rescreen after a washout)
- Resting heart rate ≥100 BPM after 5 minutes rest at screening
- Subjects with any other clinically relevant ECG parameter abnormality (e.g., PR interval, QRS deviation) or any clinically significant ECG abnormality will be excluded from the study. Any clinically significant abnormalities on 12-lead ECG at screening including, but not limited to any of the following:
- PR interval >200 msec or <120 msec
- Non-specific intra-ventricular conduction delay (IVCD) with QRS duration ≥110 msec and where the morphology does NOT meet criteria for left (LBBB) or right bundle branch block (RBBB)
- Incomplete RBBB as defined by QRS duration ≥110 msec but <120 msec with RBBB pattern
- Complete RBBB and LBBB
- Evidence of second- or third- degree AV block
- Pathological Q-waves (Q-wave wider than 0.04 sec or depth greater than 0.4-0.5 mV)
- Evidence of ventricular pre-excitation
- Evidence of left axis deviation (left axis deviation is -30 to -90 degrees) but not normal leftward axis, ST-T wave abnormalities, LBBB and/or RBBB
- Any clinically significant murmurs evident on auscultation of the heart (including evidence of mitral valve prolapse)
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3.0X upper limit of normal (ULN), gamma-glutamyl transferase (GGT) >3X ULN, and total bilirubin >2X ULN. If all liver function tests (LFTs) are within normal limits (WNL) and total bilirubin is elevated, examination of direct and indirect bilirubin may be conducted. Subjects with indirect total bilirubin up to 3X ULN are presumed to have Gilbert's syndrome and may be enrolled if all other LFTs are WNL
- Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)
- Diagnosis of HIV
- Patients with multiple sclerosis on dimethyl fumarate (tecfidera)
- Patients with asthma on biological therapy (i.e. mepolizumab, omalizumab)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Pittsburgh Asthma Institute at UPMC
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of this study is to demonstrate the efficacy and safety of 10-nitro-9(E)-octadec-9-enoic acid (CXA-10) in obese adult asthmatics. The study's hypothesis is that 150 mg/day of CXA-10 for 12 weeks will alleviate obesity-related airway hyper-reactivity in obese adult asthmatics.
- Conditions
- Asthma
- Being tested
- CXA-10, Placebo
- Keywords
- Asthma, Obesity, Nitrated fatty acids
- Medical subject headings
- Asthma, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXA-10Drug
Also called 10-nitro-octadeca-9-enoic acid
Liquid-filled capsule containing 150 mg CXA-10 in super refined olive oil.
PlaceboDrug
Liquid-filled capsule containing olive oil manufactured to mimic CXA-10 150 mg capsule
| Study group | Role | What they receive |
|---|---|---|
| 10-nitro-octadeca-9-enoic acid (CXA-10) | Experimental | CXA-10 150 mg tablet taken orally once a day for 12 weeks Receives: Drug: CXA-10 |
| Placebo | Placebo comparator | Placebo 150 mg tablet taken orally once a day for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in airway responsiveness after treatment with CXA-10 using a methacholine challenge test
Measured by the response to administration of methacholine. The PC20 is a calculated value of the amount of methacholine required to cause a 20% fall in the subject's FEV1.
Measured: 12 weeks
Secondary outcomes (3)
Treatment with CXA-10 compared to baseline: Change in the concentration of Nitrite/Nitrate (NO2/NO3). and NO2-Conjugated Linoleic Acid (CLA) in plasma and urine
Measured using analysis of plasma and urine at baseline and after treatment with CXA-10.
Measured: 12 weeks
Treatment with CXA-10 compared to baseline: Characterization of the pharmacokinetic (PK) profile of CXA-10 in plasma and urine
Measured using analysis of plasma and urine at baseline and after treatment with CXA-10.
Measured: 12 weeks
Treatment with CXA-10 compared to baseline: Changes in airway epithelial gene expression
Measured using bronchial samples from the subjects randomized to undergo a bronchoscopy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Why it stopped: The study will not take place at the University of Pittsburgh
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sally E. Wenzel MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sally E. Wenzel MD, University of Pittsburgh
- Investigators
- Sally E Wenzel, MD, Principal investigator, The University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680976
- Sponsor's protocol ID
- PRO16020149
- Acronym
- ALMA
- Status last verified
- Sep 2018
- First submitted
- 9 Mar 2016
- Last updated
- 21 Sep 2018
- Results posted
- No
- 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 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammatory Lipid Mediators in Asthma
- ClinicalTrials.gov ID
- NCT03680976
- Acronym / sponsor ID
- ALMA / PRO16020149
- Conditions
- Asthma
- Keywords
- Asthma, Obesity, Nitrated fatty acids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study will not take place at the University of Pittsburgh
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sally E. Wenzel MDUniversity, hospital or other
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 21 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 purpose of this study is to demonstrate the efficacy and safety of 10-nitro-9(E)-octadec-9-enoic acid (CXA-10) in obese adult asthmatics. The study's hypothesis is that 150 mg/day of CXA-10 for 12 weeks will alleviate obesity-related airway hyper-reactivity in obese adult asthmatics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10-nitro-octadeca-9-enoic acid (CXA-10) | Experimental | Drug: CXA-10CXA-10 150 mg tablet taken orally once a day for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 150 mg tablet taken orally once a day for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adequate completion of informed consent process with written documentation. Male and female patients, 18 to 65 yrs old female subjects should be either post-menopausal, surgically sterile, or women of child-bearing potential (WOCP) with a negative pregnancy test prior to entering the study and who agree to use an acceptable method of contraception, for the duration of the study.
- Diagnosis of asthma: based on previous physician diagnosis for > 6 months, and either baseline pre-bronchodilator (BD) FEV1 between 50 and 90% predicted with a 12% or greater bronchodilator response to 4 puffs of albuterol or PC20 methacholine (16 mg) if no BD response (<12% change), within 2 years of Visit 0. If no historical reversibility or historical PC20, and the participant does not reverse 12% at V0, the participant can return for V0a to meet this eligibility criteria.
- Daily treatment with inhaled corticosteroids and long acting beta agonists (ICS/LABA) combination medication for at least 3 months; on a stable dose for the 4 weeks prior to Visit 0
- Asthma control questionnaire ACQ > 1.5 \& ≤ 3
- Smoking history <10 pack years and no smoking in the last year
Key exclusion criteria (37 listed)
- Respiratory tract infection within the last 4 weeks
- Oral or systemic corticosteroid burst within the last 4 weeks
- Asthma-related hospitalization within the last 2 months
- Three or more asthma exacerbations requiring treatment with systemic corticosteroids in the past year consistent with severe asthma
- Asthma-related ER visit within the previous 4 weeks
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 |
|---|---|---|
| CXA-10Also: 10-nitro-octadeca-9-enoic acidLiquid-filled capsule containing 150 mg CXA-10 in super refined olive oil. | Drug | 10-nitro-octadeca-9-enoic acid (CXA-10) |
| PlaceboLiquid-filled capsule containing olive oil manufactured to mimic CXA-10 150 mg capsule | Drug | Placebo |
Primary outcome
Change in airway responsiveness after treatment with CXA-10 using a methacholine challenge test
Time frame: 12 weeks
Measured by the response to administration of methacholine. The PC20 is a calculated value of the amount of methacholine required to cause a 20% fall in the subject's FEV1.
3 secondary outcomes
Treatment with CXA-10 compared to baseline: Change in the concentration of Nitrite/Nitrate (NO2/NO3). and NO2-Conjugated Linoleic Acid (CLA) in plasma and urine
Time frame: 12 weeks
Treatment with CXA-10 compared to baseline: Characterization of the pharmacokinetic (PK) profile of CXA-10 in plasma and urine
Time frame: 12 weeks
Treatment with CXA-10 compared to baseline: Changes in airway epithelial gene expression
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
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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.
Sally E Wenzel, MD principal investigator
The University of Pittsburgh
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 CXA-10 in people with Asthma, run by Sally E. Wenzel 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 11 inclusion and 37 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: withdrawn, as of the sponsor's last update on 21 Sep 2018. 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. 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 in airway responsiveness after treatment with CXA-10 using a methacholine challenge test (time frame: 12 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 21 Sep 2018.