Safety and Efficacy of CRD007 in Adult Asthma Subjects
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|ClinicalTrials.gov Identifier: NCT02615080|
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : February 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: CRD007 Drug: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||November 30, 2015|
|Actual Primary Completion Date :||February 21, 2017|
|Actual Study Completion Date :||February 24, 2017|
Active Comparator: CRD007
CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks
Other Name: Pemirolast sodium
Placebo Comparator: Placebo
Matching placebo tablets given given twice daily for 14 weeks
- Change in ICS dose [ Time Frame: Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615080
|Principal Investigator:||Vibeke Backer, MD||Bispebjerg Hospital|