AsthmaPhase 2NCT02615080
Safety and Efficacy of CRD007 in Adult Asthma Subjects
A Phase 2 study testing CRD007 in people with Asthma, run by RSPR Pharma AB at 24 sites in 4 countries.
Trial summary
This is a double-blind, randomised, placebo-controlled, parallel group, Phase 2 trial evaluating CRD007 administered orally b.i.d for 14 weeks for the treatment of asthma. CRD007 will be given as add on to a background of commonly used controller medication, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- CRD007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 30 Nov 2015to 24 Feb 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age ≥18 years old
- Diagnosis of asthma according to Global Initiative for Asthma (GINA) Guidelines
- Atopic phenotype as assessed by the investigator
- Treated with ICS and LABA for at least 12 weeks prior to Visit 1with protocol defined daily doses
- Blood eosinophils ≥0.15*109/L at Visit 1
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- Demonstration of forced expiratory volume at one second (FEV1) >60% of the predicted value at Visit 1
- Demonstration of ACQ6 ≥ 0.5 and ≤1.5 at Visit 1
- Reversibility of at least 12% and 200 mL in FEV1
Who cannot join
- Lower respiratory tract infection <6 weeks prior to Visit 1
- Current smokers
- Significant concurrent, uncontrolled medical condition as defined by the protocol
- Others, as defined in the protocol
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
Poland8 sites
Centrum Badań Klinicznych PI-House Sp. Z O.O.
Gdansk, 80-546
Medica Pro Familia
Katowice, 40-954
NZOZ Centrum Medcyczne ProMiMed
Krakow, 31-637
Medica Pro Familia
Krákow, 30-002
Clinical Best Solution
Lublin, 20-045
NZOZ ALERGO-MED. Specjalistyczna Przychodnia Lekarska
Poznan, 60-823
Medica Pro Familia
Warsaw, 01-868
Centrum Medyczne Oporów
Wroclaw, 52-416
Bulgaria7 sites
MHAT St. Ivan Rilski-2003 Ltd., Department of Internal Medicine
Dupnitsa, 2600
SHATPPD - Pazardzhik EOOD, Department of phthisiatrics pneumonia and pulmonary functional diagnostics
Pazardzhik, 4400
Medical Center - Razgrad OOD, Office of Pneumonology and Phthisiatry
Razgrad, 7200
Medical Center Smolyan OOD, Office of Clinical Allergology
Smolyan, 4700
First MHAT - Sofia EAD, Third Department of Internal Medicine
Sofia, 1000
MHAT Lyulin EAD, Department of Internal Medicine
Sofia, 1336
SHATPPD Vratsa Ltd, Department of Pneumology
Vratsa, 3000
Denmark5 sites
Aalborg Universitetshospital
Aalborg, 9000
Hvidovre Hospital
Hvidovre, 2650
Bisbebjerg Hospital
København NV, 2400
Næstved Sygehus, Lungemedinsk afdeling
Næstved, 4700
Regionshospitalet Silkeborg
Silkeborg, 8600
United Kingdom4 sites
The Medicines Evaluation Unit (MEU) Ltd
Manchester, M23 9QZ
Medinova North London Clinical Studies Center
Northwood, HA6 2RN
Medinova East London Clinical Studies Centre
Romford, RM1 3LT
Medinova South London Clinical Studies Centre
Sidcup, DA14 6LT
About this study
Official title: A Double-Blind, Randomised, Placebo-controlled, Parallel Group, International, Multi-centre Phase 2 Trial Investigating the Safety and Efficacy of CRD007 in Adult Subjects With Asthma
This is a double-blind, randomised, placebo-controlled, parallel group, Phase 2 trial evaluating CRD007 administered orally b.i.d for 14 weeks for the treatment of asthma. CRD007 will be given as add on to a background of commonly used controller medication, i.e. inhaled corticosteroid (ICS) with or without long-acting beta2-agonist (LABA). By gradually reducing the background controller medication, the efficacy and safety of CRD007 will be evaluated on top of several dose levels of this medication.
Read the detailed description
The present trial will include subjects with diagnosed asthma. The trial involves a total of 11 visits (Visit 1-2 are screening visits, visit 3 randomisation visit, visits 4-10 treatment visits and visit 11 follow-up visit).
The subjects will be monitored by medically qualified staff every second week at clinic visits, where the reduction of their background controller medication will be reduced, if their asthma is controlled.
Between visits to the clinic the subjects have to complete a diary.
- 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CRD007 | Active comparator | CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks Receives: Drug: CRD007 |
| Placebo | Placebo comparator | Matching placebo tablets given given twice daily for 14 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ICS dose
Measured: Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study start30 Nov 2015
- Primary completion21 Feb 2017
- Study completion24 Feb 2017
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 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
- NCT02615080
- Sponsor's protocol ID
- RSPR-008
- Status last verified
- Feb 2017
- First submitted
- 17 Nov 2015
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomised, Placebo-controlled, Parallel Group, International, Multi-centre Phase 2 Trial Investigating the Safety and Efficacy of CRD007 in Adult Subjects With Asthma
- ClinicalTrials.gov ID
- NCT02615080
- Acronym / sponsor ID
- RSPR-008
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- RSPR Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 21 Feb 2017 (actual)
- Study completion
- 24 Feb 2017 (actual)
- First posted
- 25 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, parallel group, Phase 2 trial evaluating CRD007 administered orally b.i.d for 14 weeks for the treatment of asthma. CRD007 will be given as add on to a background of commonly used controller medication, i.e. inhaled corticosteroid (ICS) with or without long-acting beta2-agonist (LABA). By gradually reducing the background controller medication, the efficacy and safety of CRD007 will be evaluated on top of several dose levels of this medication.
Detailed description
The present trial will include subjects with diagnosed asthma. The trial involves a total of 11 visits (Visit 1-2 are screening visits, visit 3 randomisation visit, visits 4-10 treatment visits and visit 11 follow-up visit).
The subjects will be monitored by medically qualified staff every second week at clinic visits, where the reduction of their background controller medication will be reduced, if their asthma is controlled.
Between visits to the clinic the subjects have to complete a diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRD007 | Active comparator | Drug: CRD007CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo tablets given given twice daily for 14 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent
- Age ≥18 years old
- Diagnosis of asthma according to Global Initiative for Asthma (GINA) Guidelines
- Atopic phenotype as assessed by the investigator
- Treated with ICS and LABA for at least 12 weeks prior to Visit 1with protocol defined daily doses
Key exclusion criteria (4 listed)
- Lower respiratory tract infection <6 weeks prior to Visit 1
- Current smokers
- Significant concurrent, uncontrolled medical condition as defined by the protocol
- Others, as defined 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 sodium | Drug | CRD007 |
| Placebo | Drug | Placebo |
Primary outcome
Change in ICS dose
Time frame: Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18)
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 27 Feb 2017.
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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
24 sites in 4 countries: 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 24 sites in 4 countries.
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 9 inclusion and 4 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 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Poland, Bulgaria, Denmark, United Kingdom. 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?
Change in ICS dose (time frame: Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18)). 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 27 Feb 2017.