AsthmaPhase 1NCT04108377
Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma
A Phase 1 study testing Roflumilast in people with Asthma, run by University of California, Davis at 1 site in United States.
Trial summary
This study evaluates the effects of roflumilast on restoring response β2 adrenoreceptor agonists in low T2, obese asthmatics. One group of participants will receive roflumilast for 3 months, while the other will receive a placebo. 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?
- Roflumilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2019to 15 Aug 2023
- Phase
- Phase 1
- 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
- Have a physician diagnosis of asthma.
- Require treatment with moderate to high-dose >2500mcg/day of fluticasone or equivalent, or use of oral steroids
- Also two of the following:
- Requirement for additional daily treatment with other controller medication
- Daily Asthma symptoms
- Forced Expiratory Volume / Forced Vital Capacity (FEV1/FVC) < 70% and FEV1< 80% predicted
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- ≥1 urgent care visits/year
- ≥3 oral steroid bursts/year
- Near-fatal asthma event.
- Exhaled Nitric oxide (FeNO)<30 ppb
- Peripheral blood eosinophil count < 300 (x10-6/ul)
- Obesity, BMI≥30
Who cannot join
- Less than 18 years of age
- baseline FEV1 <30% predicted
- pregnant or nursing women
- current smokers or subject with >20 pack year history
- any history of intolerance of, or reaction to, Roflumilast.
- Prisoners
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- Patients with liver disease
- Subjects with Hepatic impairment (contraindicated in moderate-to-severe liver impairment: Child-Pugh Score Class B/C) for example.
- Patients with clinically significant psychiatric history (i.e., suicidality, etc.) and psychiatric illness
- Patients using strong CYP 450 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phosphodiesterase 4 Inhibitor, Roflumilast, Improves Beta Agonist Responsiveness Compared to Placebo in Low T2 Asthma Patients.
This study evaluates the effects of roflumilast on restoring response β2 adrenoreceptor agonists in low T2, obese asthmatics. One group of participants will receive roflumilast for 3 months, while the other will receive a placebo.
Read the detailed description
T2 low asthma is common in obese asthmatics. New evidence suggests that hyperinsulinemia and insulin resistance, both common in obesity, are associated with an increased risk of concurrent asthma.
Targeting Phosphodiesterase 4 inhibitors (PDE4) allows for examination of a mechanism potentially linking obesity and asthma as well as identification of readily available and safe options to treat hyperinsulinemic, overweight asthmatics.
It is hypothesized that obesity and hyperinsulinemia contribute to asthma by impairing β2 adrenoreceptor function and that this can be rescued the PDE4 inhibitor, roflumilast.
- Conditions
- Asthma
- Being tested
- Roflumilast, Placebo
- Keywords
- Hyperinsulinemia, Phosphodiesterase 4 Inhibitor
- Medical subject headings
- Asthma, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoflumilastDrug
Also called Daliresp
Roflumilast capsule
PlaceboDrug
Also called Placebo for Roflumilast
Sugar pill manufactured to mimic look of Roflumilast capsule
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast | Experimental | Roflumilast 500mcg by mouth, once daily, for 70 days (10 weeks). Receives: Drug: Roflumilast |
| Placebo | Placebo comparator | Placebo by mouth, once daily, for 70 days (10 weeks). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beta 2 Agonist response from Baseline
Determine whether β2 receptor responsiveness is improved in response to albuterol in Group 1 (Roflumilast) patients compared to Group 2 (Placebo) patients at the study entry.
Measured: 3 months
Secondary outcomes (2)
Exhaled nitric oxide
Determine where exhaled nitric oxide is lower in Group 1 vs Group 2
Measured: 3 months
Asthma Control Test score
The Asthma Control Test (TM © 2002 by QualityMetric) is a validated instrument to measure symptom control in asthma patients. There are 5 questions each with a score of 1-5 (25 total points). Poor asthma control is considered with a score less than 20 out of 25.
Determine whether Asthma Control Test score is improved in Group 1 vs Group 2
Asthma Control TestTM
- In the past 4 weeks, how much of the time did your asthma keep you from getting as much done at work, school or at home?
- During the past 4 weeks, how often have you had shortness of breath?
- During the past 4 weeks, how often did your asthma symptoms (wheezing, coughing, shortness of breath, chest tightness or pain) wake you up at night or earlier than usual in the morning?
- In the past 4 weeks, how often have you used your rescue inhaler or nebulizer medication (such as albuterol)?
- How would you rate your asthma control during the past 4 weeks?
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start21 Jan 2019
- Primary completion11 Dec 2022
- Study completion15 Aug 2023
Why it stopped: Enrollment stopped secondary to completion of funding
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.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Kenyon, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108377
- Sponsor's protocol ID
- 1406843
- Status last verified
- May 2023
- First submitted
- 26 Sep 2019
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phosphodiesterase 4 Inhibitor, Roflumilast, Improves Beta Agonist Responsiveness Compared to Placebo in Low T2 Asthma Patients.
- ClinicalTrials.gov ID
- NCT04108377
- Acronym / sponsor ID
- 1406843
- Conditions
- Asthma
- Keywords
- Hyperinsulinemia, Phosphodiesterase 4 Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment stopped secondary to completion of funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 11 Dec 2022 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 30 Sep 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.
This study evaluates the effects of roflumilast on restoring response β2 adrenoreceptor agonists in low T2, obese asthmatics. One group of participants will receive roflumilast for 3 months, while the other will receive a placebo.
Detailed description
T2 low asthma is common in obese asthmatics. New evidence suggests that hyperinsulinemia and insulin resistance, both common in obesity, are associated with an increased risk of concurrent asthma.
Targeting Phosphodiesterase 4 inhibitors (PDE4) allows for examination of a mechanism potentially linking obesity and asthma as well as identification of readily available and safe options to treat hyperinsulinemic, overweight asthmatics.
It is hypothesized that obesity and hyperinsulinemia contribute to asthma by impairing β2 adrenoreceptor function and that this can be rescued the PDE4 inhibitor, roflumilast.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roflumilast | Experimental | Drug: RoflumilastRoflumilast 500mcg by mouth, once daily, for 70 days (10 weeks). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo by mouth, once daily, for 70 days (10 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have a physician diagnosis of asthma.
- Require treatment with moderate to high-dose >2500mcg/day of fluticasone or equivalent, or use of oral steroids
- Requirement for additional daily treatment with other controller medication
- Daily Asthma symptoms
- Forced Expiratory Volume / Forced Vital Capacity (FEV1/FVC) < 70% and FEV1< 80% predicted
Key exclusion criteria (10 listed)
- Less than 18 years of age
- baseline FEV1 <30% predicted
- pregnant or nursing women
- current smokers or subject with >20 pack year history
- any history of intolerance of, or reaction to, Roflumilast.
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 |
|---|---|---|
| RoflumilastAlso: DalirespRoflumilast capsule | Drug | Roflumilast |
| PlaceboAlso: Placebo for RoflumilastSugar pill manufactured to mimic look of Roflumilast capsule | Drug | Placebo |
Primary outcome
Change in Beta 2 Agonist response from Baseline
Time frame: 3 months
Determine whether β2 receptor responsiveness is improved in response to albuterol in Group 1 (Roflumilast) patients compared to Group 2 (Placebo) patients at the study entry.
2 secondary outcomes
Exhaled nitric oxide
Time frame: 3 months
Asthma Control Test score
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Enrollment stopped secondary to completion of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Learn more or sign up for the study here!Link provided by the sponsor.
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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.
Nicholas Kenyon, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Roflumilast in people with Asthma, run by University of California, Davis 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 12 inclusion and 10 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: stopped early, as of the sponsor's last update on 24 Oct 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Enrollment stopped secondary to completion of funding). 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 in Beta 2 Agonist response from Baseline (time frame: 3 months). 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 24 Oct 2023.