RSPR-007 Mannitol Challenge Trial

November 15, 2016 updated by: RSPR Pharma AB

A Double-Blind, Randomised, Placebo-controlled, Cross-over, Phase 2 Mannitol Challenge Trial, Investigating the Efficacy of CRD007 in Adult Subjects With Asthma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • 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

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
      • København NV, Denmark, 2400
        • Bisbebjerg Hospital

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

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo tables are given as a single dose
Other: Placebo
One single dose given 3 hours prior to Mannitol challenge
Active Comparator: CRD007 Low dose
"Low dose" of CRD007 (pemirolast sodium) given as a single dose
Drug: CRD007
One single dose given 3 hours prior to Mannitol challenge
Other Names:
  • Pemirolast sodium
Active Comparator: CRD007 High dose
"High dose" CRD007 (pemirolast sodium) given as a single dose
Drug: CRD007
One single dose given 3 hours prior to Mannitol challenge
Other Names:
  • Pemirolast sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PD15 for mannitol after treatment with CRD007 and placebo
Time Frame: 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)
Forced expiratory volume at one second (FEV1) manoeuvres are performed 60 seconds after each dose

Collaborators and Investigators

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

Sponsor

RSPR Pharma AB

Investigators

  • 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

March 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Estimate)

November 16, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSPR-007

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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