Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Fexofenadine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
- Change from baseline in Forced Expiratory Volume FEV1
- Change in Daily Asthma Symptoms Score from baseline.
| Estimated Enrollment: | 1000 |
| Study Start Date: | February 2002 |
| Study Completion Date: | October 2003 |
| Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
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 corticosteroids, 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| Ages Eligible for Study: | 12 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New Jersey | |
| Aventis Pharmaceuticals Inc. | |
| Bridgewater, New Jersey, United States, 08807 | |
| Costa Rica | |
| Sanofi-Aventis Admnistrative Office | |
| Costa Rica, Costa Rica | |
| Guatemala | |
| Sanofi-Aventis Administrative Office | |
| Guatemala City, Guatemala | |
| Hungary | |
| sanofi-aventis Hungaria | |
| Budapest, Hungary | |
| Mexico | |
| Sanofi-Aventis Administrative Office | |
| Mexico, Mexico | |
| Poland | |
| sanofi-aventis Poland | |
| Warszawa, Poland | |
| Russian Federation | |
| Sanofi-Aventis Aministrative Office | |
| Moscow, Russian Federation | |
| Study Director: | ICD CSD | Sanofi |
More Information
Additional Information:
No publications provided
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00044824 History of Changes |
| Other Study ID Numbers: | M016455P/3002, M016455 |
| Study First Received: | September 5, 2002 |
| Last Updated: | August 20, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fexofenadine Terfenadine |
Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013