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RSPR-007 Mannitol Challenge Trial

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ClinicalTrials.gov Identifier: NCT02609334
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
RSPR Pharma AB

Brief Summary:
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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomised, Placebo-controlled, Cross-over, Phase 2 Mannitol Challenge Trial, Investigating the Efficacy of CRD007 in Adult Subjects With Asthma
Study Start Date : March 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Mannitol

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 Name: 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 Name: Pemirolast sodium




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02609334


Locations
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Denmark
Hvidovre Hospital
Hvidovre, Denmark, 2650
Bisbebjerg Hospital
København NV, Denmark, 2400
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: NCT02609334    
Other Study ID Numbers: RSPR-007
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2015
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
Mannitol
Pemirolast
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action