RSPR-007 Mannitol Challenge Trial

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609334
• Other study ID #: RSPR-007
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2015
• Last updated: November 15, 2016
• Start date: March 2015
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: RSPR Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CRD007
One single dose given 3 hours prior to Mannitol challenge

Other:
• Placebo
One single dose given 3 hours prior to Mannitol challenge

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Bisbebjerg Hospital	København NV

Sponsors (1)

Lead Sponsor	Collaborator
RSPR Pharma AB

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD15 for mannitol after treatment with CRD007 and placebo	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	No