Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2015-03-31
2015-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Matching placebo tables are given as a single dose
Placebo
One single dose given 3 hours prior to Mannitol challenge
CRD007 Low dose
"Low dose" of CRD007 (pemirolast sodium) given as a single dose
CRD007
One single dose given 3 hours prior to Mannitol challenge
CRD007 High dose
"High dose" CRD007 (pemirolast sodium) given as a single dose
CRD007
One single dose given 3 hours prior to Mannitol challenge
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CRD007
One single dose given 3 hours prior to Mannitol challenge
Placebo
One single dose given 3 hours prior to Mannitol challenge
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥18 and \<50 years
* Diagnosis of asthma
Exclusion Criteria
* Lower respiratory tract infection \<6 weeks prior to Visit 1
* Others, as specified in the protocol
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RSPR Pharma AB
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vibeke Backer, MD
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hvidovre Hospital
Hvidovre, , Denmark
Bisbebjerg Hospital
København NV, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RSPR-007
Identifier Type: -
Identifier Source: org_study_id