NCT00914654

Brief Summary

The purpose of the study is to assess the blood and urine concentrations of inhaled formoterol.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 5, 2009

Status Verified

June 1, 2009

Enrollment Period

1.4 years

First QC Date

June 4, 2009

Last Update Submit

June 4, 2009

Conditions

Asthma

Keywords

AsthmaDopingFormoterolUrinary concentrationsBeta-agonists

Outcome Measures

Primary Outcomes (1)

  • Serum and urine concentrations of formoterol

    baseline, 4, 8, and 12 hours after medicine administration

Study Arms (3)

Healthty

OTHER

10 healthy men

Drug: inhaled formoterol

Asthmatics

OTHER

10 male asthmatic subjects

Drug: inhaled formoterol

Elite asthmatics

OTHER

10 male elite athletes with asthma

Drug: inhaled formoterol

Interventions

inhaled formoterolDRUG

Inhalation of 18 microgram formoterol as one dose. Oxis Turbohaler 9 microg/dose, MA no. 30072.

Also known as: Oxis Turbohaler 9 microg/dose, MA no. 30072.
AsthmaticsElite asthmaticsHealthty

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physician-diagnosed asthma with positive reversibility or challenge test.
  • Informed consent.
  • Age between 18-45 years.
  • Sex: male.
  • Asthma classified as mild to moderate according to GINA guidelines.
  • Used beta-2-agonist in minimum 12 months.

You may not qualify if:

  • Smokers or ex-smokers with a smoking history of 10 pack years or more.
  • Respiratory tract infections within the last 2 weeks prior to study day.
  • Subjects with other chronic diseases than asthma and allergy.
  • Allergy towards the study medicine.
  • Use of beta-2-agonist 10 days prior to study day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital, Respiratory Research Unit

København NV, DK-2400, Denmark

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jimmi Elers, MD

    Bispebjerg Hospital, Respiratory Research Unit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jimmi Elers, MD

CONTACT

+45 35313208jele0004@bbh.regionh.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 5, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 5, 2009

Record last verified: 2009-06

Locations

DK(1)