Asthma
Conditions
Brief 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.
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.
Interventions
DRUGCRD007
One single dose given 3 hours prior to Mannitol challenge
OTHERPlacebo
One single dose given 3 hours prior to Mannitol challenge
Sponsors
RSPR Pharma AB
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Age ≥18 and \<50 years * Diagnosis of asthma
Exclusion criteria
* Clinical significant comorbidities * Lower respiratory tract infection \<6 weeks prior to Visit 1 * Others, as specified in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PD15 for mannitol after treatment with CRD007 and placebo | 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) |
Countries
Denmark
Outcome results
None listed