NCT00214019

Brief Summary

This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or the combination treatment with fluticasone and salmeterol, is associated with a greater number of sputum eosinophils following antigen challenge and, under these circumstances, the migrating peripheral blood eosinophils are less adherent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2003

Longer than P75 for not_applicable

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

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

August 8, 2016

Completed
Last Updated

November 21, 2017

Status Verified

October 1, 2017

Enrollment Period

4.2 years

First QC Date

September 13, 2005

Results QC Date

August 17, 2011

Last Update Submit

October 17, 2017

Conditions

Allergic Asthma

Outcome Measures

Primary Outcomes (1)

  • Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge

    Sputum samples were collected from the participants. Cell counts were made from these samples after treatment with 0.1% dithiothreitol. Percentage of eosinophils were reported. Time frame measurement was 24 hours after the subject had an antigen challenge.

    Eosinophils are measured 24 hours after the subject has an antigen challenge

Study Arms (4)

Placebo Diskus

PLACEBO COMPARATOR

Placebo comparator

Drug: Placebo

Salmeterol Diskus 50 mcg twice per day

EXPERIMENTAL

Salmeterol Diskus 50 mcg twice per day

Drug: salmeterol

Placebo diskus, fluticasone

EXPERIMENTAL

placebo diskus, fluticasone MDI 88 mcg twice per day

Drug: Fluticasone

Salmeterol, Fluticasone

EXPERIMENTAL

Salmeterol diskus 50 mcg BID, fluticasone MDI 88 mcg twice per day

Drug: salmeterolDrug: Fluticasone

Interventions

salmeterolDRUG

salmeterol diskus 50 mcg twice per day

Also known as: Seravent, Advair
Salmeterol Diskus 50 mcg twice per daySalmeterol, Fluticasone
FluticasoneDRUG

placebo diskus, fluticasone MDI 88 mcg twice per day

Also known as: flovent, advair
Placebo diskus, fluticasoneSalmeterol, Fluticasone
PlaceboDRUG

placebo diskus

Also known as: no drug, comparator treatment
Placebo Diskus

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • history of asthma symptoms for the previous 6 months
  • Forced Expiratory Value (FEV1) \>75% of predicted
  • positive prick skin test to cat, house dust mite or ragweed

You may not qualify if:

  • history of life threatening asthma or anaphylaxis
  • current smoker
  • pregnant or breast-feeding
  • evidence of an upper respiratory infection within 4 weeks of screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Salmeterol XinafoateFluticasone-Salmeterol Drug CombinationFluticasone

Intervention Hierarchy (Ancestors)

AlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesAndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Limitations and Caveats

36 subjects were screened, identifying subjects with both a peripheral eosinophil count \>0.200x106 cells/ml and a LPR \>15% was more difficult than expected. Of the subjects screened, only 12 met criteria and 6 subjects completed.

Results Point of Contact

Title
Gina Crisafi
Organization
UW Madison
gmc@medicine.wisc.edu
6082654554

Study Officials

  • William Busse, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

November 1, 2003

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

November 21, 2017

Results First Posted

August 8, 2016

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)