Safety and Efficacy of CRD007 in Adult Asthma Subjects

February 24, 2017 updated by: RSPR Pharma AB

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Dupnitsa, Bulgaria, 2600
        • MHAT St. Ivan Rilski-2003 Ltd., Department of Internal Medicine
      • Pazardzhik, Bulgaria, 4400
        • SHATPPD - Pazardzhik EOOD, Department of phthisiatrics pneumonia and pulmonary functional diagnostics
      • Razgrad, Bulgaria, 7200
        • Medical Center - Razgrad OOD, Office of Pneumonology and Phthisiatry
      • Smolyan, Bulgaria, 4700
        • Medical Center Smolyan OOD, Office of Clinical Allergology
      • Sofia, Bulgaria, 1000
        • First MHAT - Sofia EAD, Third Department of Internal Medicine
      • Sofia, Bulgaria, 1336
        • MHAT Lyulin EAD, Department of Internal Medicine
      • Vratza, Bulgaria, 3000
        • SHATPPD Vratsa Ltd, Department of Pneumology
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Universitetshospital
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
      • København NV, Denmark, 2400
        • Bisbebjerg Hospital
      • Næstved, Denmark, 4700
        • Næstved Sygehus, Lungemedinsk afdeling
      • Silkeborg, Denmark, 8600
        • Regionshospitalet Silkeborg
  • Poland
      • Gdańsk, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
      • Katowice, Poland, 40-954
        • Medica Pro Familia
      • Kraków, Poland, 31-637
        • NZOZ Centrum Medcyczne ProMiMed
      • Krákow, Poland, 30-002
        • Medica Pro Familia
      • Lublin, Poland, 20-045
        • Clinical Best Solution
      • Poznan, Poland, 60-823
        • NZOZ ALERGO-MED. Specjalistyczna Przychodnia Lekarska
      • Warszawa, Poland, 01-868
        • Medica Pro Familia
      • Wroclaw, Poland, 52-416
        • Centrum Medyczne Oporow
  • United Kingdom
      • Manchester, United Kingdom, M23 9QZ
        • The Medicines Evaluation Unit (MEU) Ltd
      • Northwood, United Kingdom, HA6 2RN
        • Medinova North London Clinical Studies Center
      • Romford, United Kingdom, RM1 3LT
        • Medinova East London Clinical Studies Centre
      • Sidcup, United Kingdom, DA14 6LT
        • Medinova South London Clinical Studies Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: CRD007
CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks
Drug: CRD007
Other Names:
  • Pemirolast sodium
Placebo Comparator: Placebo
Matching placebo tablets given given twice daily for 14 weeks
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in ICS dose
Time Frame: Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18)
Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RSPR Pharma AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vibeke Backer, MD, Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 21, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 24, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RSPR-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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