AsthmaPhase 2NCT02609334
RSPR-007 Mannitol Challenge Trial
A Phase 2 study testing CRD007 in people with Asthma, run by RSPR Pharma AB at 2 sites in Denmark.
Trial summary
This is a double-blind, randomised, placebo-controlled, cross-over, Phase 2 trial evaluating two doses (a low and a high) of CRD007 for the treatment of asthmatic trial subjects with a positive asthma test (mannitol challenge) prior to enrolment. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- CRD007
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2015to Jul 2015
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent
- Age ≥18 and <50 years
- Diagnosis of asthma
Who cannot join
- Clinical significant comorbidities
- Lower respiratory tract infection <6 weeks prior to Visit 1
- Others, as specified in the protocol
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Hvidovre Hospital
Hvidovre, 2650
Bisbebjerg Hospital
København NV, 2400
About this study
Official title: A Double-Blind, Randomised, Placebo-controlled, Cross-over, Phase 2 Mannitol Challenge Trial, Investigating the Efficacy of CRD007 in Adult Subjects With Asthma
This is a double-blind, randomised, placebo-controlled, cross-over, Phase 2 trial evaluating two doses (a low and a high) of CRD007 for the treatment of asthmatic trial subjects with a positive asthma test (mannitol challenge) prior to enrolment.
Read the detailed description
The present trial will include subjects with diagnosed asthma in a provocation model which mimics assessments of asthma control. Mannitol challenge is an indirect asthma provocation test, which requires the presence of inflammatory cells, particularly mast cells, in the airways.
The trial involved in total 5 subject visits and will last for a maximum of 30 days for each subject from Visit 2 (Randomisation) to Visit 5 (Follow up).
Visit 2,3, and 4 will be treatment visits where Investigational Medicinal Product (IMP) is administrated 3 hours before the Mannitol challenge.
- Conditions
- Asthma
- Being tested
- CRD007, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRD007Drug
Also called Pemirolast sodium
One single dose given 3 hours prior to Mannitol challenge
PlaceboOther
One single dose given 3 hours prior to Mannitol challenge
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching placebo tables are given as a single dose Receives: Other: Placebo |
| CRD007 Low dose | Active comparator | "Low dose" of CRD007 (pemirolast sodium) given as a single dose Receives: Drug: CRD007 |
| CRD007 High dose | Active comparator | "High dose" CRD007 (pemirolast sodium) given as a single dose Receives: Drug: CRD007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD15 for mannitol after treatment with CRD007 and placebo
The FEV1 value taken after the 0 mg capsule is taken as pre-challenge FEV1 and used to calculate the percentage decrease in FEV1 in response to the mannitol challenge. The test ends when the FEV1 has fallen by 15% or more (PD15)
Measured: Forced expiratory volume at one second (FEV1) manoeuvres are performed 60 seconds after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- RSPR Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vibeke Backer, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609334
- Sponsor's protocol ID
- RSPR-007
- Status last verified
- Nov 2015
- First submitted
- 17 Nov 2015
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomised, Placebo-controlled, Cross-over, Phase 2 Mannitol Challenge Trial, Investigating the Efficacy of CRD007 in Adult Subjects With Asthma
- ClinicalTrials.gov ID
- NCT02609334
- Acronym / sponsor ID
- RSPR-007
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- RSPR Pharma ABIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 Nov 2015 (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, randomised, placebo-controlled, cross-over, Phase 2 trial evaluating two doses (a low and a high) of CRD007 for the treatment of asthmatic trial subjects with a positive asthma test (mannitol challenge) prior to enrolment.
Detailed description
The present trial will include subjects with diagnosed asthma in a provocation model which mimics assessments of asthma control. Mannitol challenge is an indirect asthma provocation test, which requires the presence of inflammatory cells, particularly mast cells, in the airways.
The trial involved in total 5 subject visits and will last for a maximum of 30 days for each subject from Visit 2 (Randomisation) to Visit 5 (Follow up).
Visit 2,3, and 4 will be treatment visits where Investigational Medicinal Product (IMP) is administrated 3 hours before the Mannitol challenge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboMatching placebo tables are given as a single dose |
| CRD007 Low dose | Active comparator | Drug: CRD007"Low dose" of CRD007 (pemirolast sodium) given as a single dose |
| CRD007 High dose | Active comparator | Drug: CRD007"High dose" CRD007 (pemirolast sodium) given as a single dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Written informed consent
- Age ≥18 and <50 years
- Diagnosis of asthma
Key exclusion criteria (3 listed)
- Clinical significant comorbidities
- Lower respiratory tract infection <6 weeks prior to Visit 1
- Others, as specified in the protocol
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 |
|---|---|---|
| CRD007Also: Pemirolast sodiumOne single dose given 3 hours prior to Mannitol challenge | Drug | CRD007 High dose, CRD007 Low dose |
| PlaceboOne single dose given 3 hours prior to Mannitol challenge | Other | Placebo |
Primary outcome
PD15 for mannitol after treatment with CRD007 and placebo
Time frame: Forced expiratory volume at one second (FEV1) manoeuvres are performed 60 seconds after each dose
The FEV1 value taken after the 0 mg capsule is taken as pre-challenge FEV1 and used to calculate the percentage decrease in FEV1 in response to the mannitol challenge. The test ends when the FEV1 has fallen by 15% or more (PD15)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
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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.
Vibeke Backer, MD principal investigator
Bispebjerg Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CRD007 in people with Asthma, run by RSPR Pharma AB at 2 sites in Denmark.
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 3 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: finished, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PD15 for mannitol after treatment with CRD007 and placebo (time frame: Forced expiratory volume at one second (FEV1) manoeuvres are performed 60 seconds after each dose). 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 16 Nov 2016.