NCT05749536

Brief Summary

The purpose of the study is to find blood and urine concentrations of procaterol administrated either by inhalation or by tablets in asthmatic and non-asthmatics males. We hypotheis that the concentrations of procaterol in the blood and serum is higher after tablet intake versus inhalation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

August 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2013

Completed
9.3 years until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

November 5, 2013

Last Update Submit

February 27, 2023

Conditions

Asthma

Keywords

elite athletes

Outcome Measures

Primary Outcomes (2)

  • urine concentration of drug 0-24 h

    In healthy subjects to investigate drug farmakokenetic

    7 days

  • serum concentration of drug 0-24 h

    In healthy subjects to investigate drug farmakokenetic

    7 days

Study Arms (2)

Asthma

With positive asthma test

Healthy

With no signs of asthma

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Asthmatic and healthy volunteers

You may qualify if:

  • Doctor diagnosed asthma for the asthmatic group
  • GINA 1-3 for the asthmatic group
  • Use of beta2-agonist for at least 12 months for the asthmatic group
  • age 18-45
  • males
  • informed consent

You may not qualify if:

  • smoker or former smoker
  • airway infection to weeks prior to the study or during the study
  • other chronic diseaes than asthma and allergy
  • Use of beta2-agonist 6 days prior to the study
  • Allergy to the study medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, DK-2400, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

PK study

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
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 5, 2013

First Posted

March 1, 2023

Study Start

August 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

DK(1)