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Completed

NCT Number: NCT02609334

RSPR-007 Mannitol Challenge Trial

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hvidovre Hospital, Hvidovre, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRD007

Drug

One single dose given 3 hours prior to Mannitol challenge

Other names: Pemirolast sodium

Placebo

Other

One single dose given 3 hours prior to Mannitol challenge

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

RSPR Pharma AB

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2015
Registry last updated
Nov 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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