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Safety and Efficacy of CRD007 in Adult Asthma Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02615080
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
RSPR Pharma AB

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: CRD007 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: CRD007
CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks
Drug: CRD007
Other Name: Pemirolast sodium

Placebo Comparator: Placebo
Matching placebo tablets given given twice daily for 14 weeks
Drug: Placebo



Primary Outcome Measures :
  1. Change in ICS dose [ Time Frame: Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
Show Show 24 study locations
Sponsors and Collaborators
RSPR Pharma AB
Investigators
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Principal Investigator: Vibeke Backer, MD Bispebjerg Hospital
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Responsible Party: RSPR Pharma AB
ClinicalTrials.gov Identifier: NCT02615080    
Other Study ID Numbers: RSPR-008
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pemirolast
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs