NCT00250341

Brief Summary

This is a Phase 4, single center study conducted in mild-to moderate asthmatics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Sep 2005

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

September 30, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2007

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

2 years

First QC Date

November 4, 2005

Last Update Submit

November 19, 2021

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • High resolution Cat Scans

Study Arms (2)

Advair

ACTIVE COMPARATOR
Drug: Advair

QVAR

EXPERIMENTAL
Drug: QVARDrug: Servent Diskus

Interventions

QVARDRUG

480 mcg

Also known as: beclomethasone dipropionate HFA
QVAR
AdvairDRUG

250/50 mcg

Also known as: Advair Diskus
Advair
Servent DiskusDRUG

50 mcg

QVAR

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Currently using SABA prn or a low-to-moderate persistent asthma

You may not qualify if:

  • Tobacco use within 1 year or \>= 5 pack years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

BeclomethasoneFluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, ChlorinatedSalmeterol XinafoateAlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesFluticasoneAndrostadienesAndrostenesAndrostanesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Michelle Zeidler, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2005

First Posted

November 8, 2005

Study Start

September 30, 2005

Primary Completion

September 30, 2007

Study Completion

September 30, 2007

Last Updated

December 2, 2021

Record last verified: 2021-11

Locations

US(1)