A Phase 2 interventional study of CRD007 and Placebo in Asthma, sponsored by RSPR Pharma AB. Completed at 24 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-27.
Sponsored by RSPR Pharma AB · Phase 2, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 168 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →RSPR Pharma AB is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks
Drug: CRD007
Matching placebo tablets given given twice daily for 14 weeks
Drug: Placebo
Also known as: Pemirolast sodium
Change in ICS dose
Time frame: Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18)
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
RSPR Pharma AB