Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Fexofenadine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sanofi-Aventis
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
Clinical Details
Official title: A Multicenter, Double-Blind, Randomized, Parallel Groups Placebo-Controlled Study to Assess the Efficacy and Safety of Fexofenadine 120mg BID in Subjects With Mild to Moderate Persistent Asthma
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed description:
The incidence of respiratory allergy in the US has increased gradually over the past several
years, and current estimates suggest that allergic rhinitis and bronchial asthma affect
approximately 20% and 5% of the population, respectively. Rhinitis and asthma frequently
coexist, and large-scale population surveys indicate that up to 38% of subjects with rhinitis
have asthma, and up to 78% of subjects with asthma have chronic nasal symptoms. Safety
concerns with the increased use of inhaled corticosterioids, the heterogeneity of the
disease, and poor compliance with asthma medication regimens, point to the need for the
development of safe and convenient oral therapies for asthma. Histamine is an important
chemical mediator of inflammation in asthma. The benefits of antihistamine treatment in
patients with mild to moderate asthma have been well documented, however their clinical use
has been previously limited due to the high doses required for efficacy and their associated
side effects including sedation and cognitive impairment.
Recent evidence indicates that in addition to H1-receptor antagonism, some of the newer
nonsedating, non-impairing antihistamines appear to possess various anti-inflammatory
properties at concentrations achieved at therapeutic dosages suggesting an additional benefit
of these drugs in the management of allergic diseases and asthma. 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.
Eligibility
Minimum age: 12 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
- 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).
Exclusion criteria:
- Otherwise healthy
Locations and Contacts
Aventis Pharmaceuticals Inc., Bridgewater, New Jersey 08807, United States
Additional Information
Starting date: January 2002
Last updated: April 4, 2006
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