NCT00044824

Brief Summary

The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma

Trial Health

93
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Feb 2002

Geographic Reach
7 countries

7 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

February 1, 2002

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2002

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 17, 2002

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
Last Updated

August 21, 2008

Status Verified

August 1, 2008

Enrollment Period

1.7 years

First QC Date

September 5, 2002

Last Update Submit

August 20, 2008

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Forced Expiratory Volume FEV1

Secondary Outcomes (1)

  • Change in Daily Asthma Symptoms Score from baseline.

Interventions

FexofenadineDRUG

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males and non-pregnant, non-breastfeeding females 12 through 80 years of age
  • FEV1 in the context of this study is greater than 60% and not less or equal to 87% of predicted values at Visit 1 or Visit 2 (and no short-acting agent beta-agonist use within 6 hours prior to spirometry)
  • Improvement in FEV1 of at least 12% of predicted value and at least 200ml within 15 to 30 minutes of inhaling 2 puffs of albuterol 90mcg/actuation demonstrated at study entry OR documented during the previous 12 months at the study site.
  • Use of a short-acting, beta-agonist inhaler to treat asthma symptoms on an average of at least 2 days per week during the previous 2 weeks (greater than or equal to 4 days total during the previous 2 weeks, excluding prophylactic use).

You may not qualify if:

  • Otherwise healthy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Aventis Pharmaceuticals Inc.

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis Admnistrative Office

Costa Rica, Costa Rica

Location

Sanofi-Aventis Administrative Office

Guatemala City, Guatemala

Location

sanofi-aventis Hungaria

Budapest, Hungary

Location

Sanofi-Aventis Administrative Office

México, Mexico

Location

sanofi-aventis Poland

Warsaw, Poland

Location

Sanofi-Aventis Aministrative Office

Moscow, Russia

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

fexofenadine

Condition Hierarchy (Ancestors)

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

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 5, 2002

First Posted

September 17, 2002

Study Start

February 1, 2002

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

August 21, 2008

Record last verified: 2008-08

Locations

RU(1)GU(1)CO(1)ME(1)PL(1)US(1)HU(1)