AsthmaPhase 2CREWS01NCT02153541
Assessing the Efficacy of CREWS01 to Decrease Usage of Rescue Inhalers in Moderate to Severe Asthmatic Adults
A Phase 2 study testing Antipyrine-benzocaine otic solution and Glycerin with Oxyquinoline Sulfate in people with Asthma, run by Global United Pharmaceutical Corporation at 1 site in United States.
Trial summary
This is a double-blind, randomized, placebo-controlled, proof of concept, study in adults with poorly controlled moderate to severe asthma. The researchers believe that by using a local anesthetic to block a certain nerve in the ear, it will improve all aspects of asthma, such as decreasing the numbers of times… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Antipyrine-benzocaine otic solution and Glycerin with Oxyquinoline Sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 1 Aug 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Moderate to severe asthma
- Rescue inhaler 3 times per week
- Be able to give informed consent
- Must be on inhaled corticosteroid and long-acting beta agonist (LABA), (either individually or as a combination product) and report using a short-acting beta agonist (SABA) three or more times a week in at least 2 or 3 weeks prior to stud enrollment
- Moderate or severe persistent asthma according to the National Heart, Lung, and Blood Institute (NHLBI) Guidelines, (EPR 2007)
- At least one appointment scheduled with the asthma physician during the 4 weeks of participation.
- Must be able to complete questionnaires over the phone or in person
- Must be able to maintain a basic diary/log of inhaler use and any side effects for 30 days.
Who cannot join
- Severe psychiatric or cognitive problems
- Known or suspected sensitivity to the investigational medication
- Have a stenotic ear canal
- Have a perforated ear drum
- Active Otitis Media, Otitis Externa, or Mastoiditis
- Allergic to Benzocaine
Show all 13Show fewer
- Unable to communicate in English
- Any other significant cardiopulmonary disease
- Smokers
- Hospitalized in the last 6 months for pneumonia
- Long term or lingering side effects to COVID19
- Lack of telephone or mobile phone
- Subjects who have received any investigational drug for asthma in the past 60 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Augusta University
Augusta, Georgia, 30901
Carol Smith, 706-721-9680, csmith@augusta.edu
About this study
Official title: Assessing the Efficacy of Antipyrine Benzocaine Otic Solution in the Ear Canal to Decrease Usage of Rescue Inhalers in Moderate to Severe Asthmatic Adults.
This is a double-blind, randomized, placebo-controlled, proof of concept, study in adults with poorly controlled moderate to severe asthma. The researchers believe that by using a local anesthetic to block a certain nerve in the ear, it will improve all aspects of asthma, such as decreasing the numbers of times patients have to use a rescue inhaler, and improving asthma treatment assessment questionnaire scores, with no bad changes to lung function and inflammation.
Read the detailed description
The proposed four-week, double-blind, placebo controlled study is designed to test the hypothesis that topical auricular anesthesia of the vagus nerve decreases the need for the usage of rescue inhalers in moderate to severe asthma in adults.
We anticipate that up to 50 patients will be enrolled in the trial. Particularly severe risks are not anticipated based on the prior investigational experience with this drug. This trial will be used to generate experience and data to support the design of a larger, crossover, comparator trial investigating the efficacy of antipyrine-benzocaine in reducing the need for rescue inhalers and hospital admissions in moderate to severe asthmatic adults.
- Conditions
- Asthma
- Being tested
- Antipyrine-benzocaine otic solution, Glycerin with Oxyquinoline Sulfate
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antipyrine-benzocaine otic solutionDrug
Participants receiving antipyrine-benzocaine otic solution are expected to decrease usage of rescue inhalers.
Glycerin with Oxyquinoline SulfateOther
50% of participants will receive the glycerin with oxyquinoline sulfate. These participants will be randomly selected and unaware that they are receiving the placebo and are expected to have no change in usage of rescue inhalers.
| Study group | Role | What they receive |
|---|---|---|
| Glycerin with Oxyquinoline Sulfate | Placebo comparator | For those participants who receive glycerin with oxyquinoline sulfate placebo, we do not anticipate any change in the usage of rescue inhalers, spirometer scores, asthma diaries, and expired fractionated nitrous oxide levels. Receives: Other: Glycerin with Oxyquinoline Sulfate |
| Antipyrine-benzocaine otic solution | Active comparator | Will be used on 50% of participants, we anticipate reduction in the usage of rescue inhalers, spirometer scores, asthma diaries, and expired fractionated nitrous oxide levels. Receives: Drug: Antipyrine-benzocaine otic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of CREWS01 (topical auricular anesthesia of the vagus nerve) to decrease usage of rescue inhalers in moderate to severe asthmatic adults Change in usage of rescue inhalers in moderate to severe asthmatic adults in four weeks
We anticipate 50% of patients that receive the active ingredient will decrease the usage of rescue inhalers by 50%. If the test of the two-factor interaction in the repeated measures mixed model analysis is statistically significant, and the magnitude of the change in the Crews group is at least 50%, the Crews Maneuver will be considered effective.
Measured: Each participant is studied for four weeks
Secondary outcomes (1)
Improvement of spirometry scores in moderate to severe asthmatic adults
We anticipate 50% of patients that receive the active ingredient will not show a significant decline in spirometry scores and eNO results that do not show a significant increase in subjects on the active drug compared to the placebo, and improvement in both ACT and ATAQ scores of at least 25% over the 4 weeks of study.
Measured: Each participant is studied for four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study start1 Apr 2023 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global United Pharmaceutical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John D Prosser, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153541
- Sponsor's protocol ID
- CREWS01
- Acronym
- CREWS01
- Status last verified
- Feb 2023
- First submitted
- 21 May 2014
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing after phase 3 clinical trial completed
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Antipyrine Benzocaine Otic Solution in the Ear Canal to Decrease Usage of Rescue Inhalers in Moderate to Severe Asthmatic Adults.
- ClinicalTrials.gov ID
- NCT02153541
- Acronym / sponsor ID
- CREWS01 / CREWS01
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Global United Pharmaceutical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 3 Jun 2014 (estimated)
- 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.
This is a double-blind, randomized, placebo-controlled, proof of concept, study in adults with poorly controlled moderate to severe asthma. The researchers believe that by using a local anesthetic to block a certain nerve in the ear, it will improve all aspects of asthma, such as decreasing the numbers of times patients have to use a rescue inhaler, and improving asthma treatment assessment questionnaire scores, with no bad changes to lung function and inflammation.
Detailed description
The proposed four-week, double-blind, placebo controlled study is designed to test the hypothesis that topical auricular anesthesia of the vagus nerve decreases the need for the usage of rescue inhalers in moderate to severe asthma in adults.
We anticipate that up to 50 patients will be enrolled in the trial. Particularly severe risks are not anticipated based on the prior investigational experience with this drug. This trial will be used to generate experience and data to support the design of a larger, crossover, comparator trial investigating the efficacy of antipyrine-benzocaine in reducing the need for rescue inhalers and hospital admissions in moderate to severe asthmatic adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glycerin with Oxyquinoline Sulfate | Placebo comparator | Other: Glycerin with Oxyquinoline SulfateFor those participants who receive glycerin with oxyquinoline sulfate placebo, we do not anticipate any change in the usage of rescue inhalers, spirometer scores, asthma diaries, and expired fractionated nitrous oxide levels. |
| Antipyrine-benzocaine otic solution | Active comparator | Drug: Antipyrine-benzocaine otic solutionWill be used on 50% of participants, we anticipate reduction in the usage of rescue inhalers, spirometer scores, asthma diaries, and expired fractionated nitrous oxide levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Moderate to severe asthma
- Rescue inhaler 3 times per week
- Be able to give informed consent
- Must be on inhaled corticosteroid and long-acting beta agonist (LABA), (either individually or as a combination product) and report using a short-acting beta agonist (SABA) three or more times a week in at least 2 or 3 weeks prior to stud enrollment
- Moderate or severe persistent asthma according to the National Heart, Lung, and Blood Institute (NHLBI) Guidelines, (EPR 2007)
Key exclusion criteria (13 listed)
- Severe psychiatric or cognitive problems
- Known or suspected sensitivity to the investigational medication
- Have a stenotic ear canal
- Have a perforated ear drum
- Active Otitis Media, Otitis Externa, or Mastoiditis
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 |
|---|---|---|
| Antipyrine-benzocaine otic solutionParticipants receiving antipyrine-benzocaine otic solution are expected to decrease usage of rescue inhalers. | Drug | Antipyrine-benzocaine otic solution |
| Glycerin with Oxyquinoline Sulfate50% of participants will receive the glycerin with oxyquinoline sulfate. These participants will be randomly selected and unaware that they are receiving the placebo and are expected to have no change in usage of rescue inhalers. | Other | Glycerin with Oxyquinoline Sulfate |
Primary outcome
Efficacy of CREWS01 (topical auricular anesthesia of the vagus nerve) to decrease usage of rescue inhalers in moderate to severe asthmatic adults Change in usage of rescue inhalers in moderate to severe asthmatic adults in four weeks
Time frame: Each participant is studied for four weeks
We anticipate 50% of patients that receive the active ingredient will decrease the usage of rescue inhalers by 50%. If the test of the two-factor interaction in the repeated measures mixed model analysis is statistically significant, and the magnitude of the change in the Crews group is at least 50%, the Crews Maneuver will be considered effective.
1 secondary outcome
Improvement of spirometry scores in moderate to severe asthmatic adults
Time frame: Each participant is studied for four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Yes. Data sharing after phase 3 clinical trial completed
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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.
John D Prosser, MD principal investigator
Augusta University
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 Antipyrine-benzocaine otic solution and Glycerin with Oxyquinoline Sulfate in people with Asthma, run by Global United Pharmaceutical Corporation 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 8 inclusion and 13 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 8 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carol Smith (7067219680, csmith@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of CREWS01 (topical auricular anesthesia of the vagus nerve) to decrease usage of rescue inhalers in moderate to severe asthmatic adults Change in usage of rescue inhalers in moderate to severe asthmatic adults in four weeks (time frame: Each participant is studied for four 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 8 Feb 2023.