NCT02609334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 asthma

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2 asthma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

November 17, 2015

Last Update Submit

November 15, 2016

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Matching placebo tables are given as a single dose

Other: Placebo

CRD007 Low dose

ACTIVE COMPARATOR

"Low dose" of CRD007 (pemirolast sodium) given as a single dose

Drug: CRD007

CRD007 High dose

ACTIVE COMPARATOR

"High dose" CRD007 (pemirolast sodium) given as a single dose

Drug: CRD007

Interventions

CRD007DRUG

One single dose given 3 hours prior to Mannitol challenge

Also known as: Pemirolast sodium
CRD007 High doseCRD007 Low dose
PlaceboOTHER

One single dose given 3 hours prior to Mannitol challenge

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent
  • Age ≥18 and \<50 years
  • Diagnosis of asthma

You may not qualify if:

  • Clinical significant comorbidities
  • Lower respiratory tract infection \<6 weeks prior to Visit 1
  • Others, as specified in the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Bisbebjerg Hospital

København NV, 2400, Denmark

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Vibeke Backer, MD

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 20, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

November 16, 2016

Record last verified: 2015-11

Locations

DK(2)