NCT00045955

Brief Summary

The purpose of this study is to assess the long-term safety performance of fexofenadine compared to montelukast in subjects with asthma

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Feb 2002

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

February 1, 2002

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
Last Updated

August 21, 2008

Status Verified

August 1, 2008

Enrollment Period

1.7 years

First QC Date

September 17, 2002

Last Update Submit

August 20, 2008

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Safety evaluation

Secondary Outcomes (1)

  • Pulmonary function tests.

Interventions

Fexofenadine, Comparator = MontelukastDRUG

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 40% and not less or equal to 87% of predicted values for subjects not currently taking ICS and greater than 40% and not less or equal to 95% for those subjects taking ICS at Visit 1 and/or Visit 2 (and no albuterol 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 (1)

Aventis Pharmaceutical Inc.

Bridgewater, New Jersey, 08807, United States

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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 17, 2002

First Posted

September 19, 2002

Study Start

February 1, 2002

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

August 21, 2008

Record last verified: 2008-08

Locations

US(1)