CLINICAL TRIALS PROFILE FOR ALLEGRA

All Clinical Trials for Allegra

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00103012 ↗	Drug Interactions of Echinacea, Ginseng, and Ginkgo Biloba Taken With Lopinavir/Ritonavir in Healthy Volunteers	Completed	National Institutes of Health Clinical Center (CC)	Phase 4	2005-01-01	This study will examine the interaction of the HIV combination medication lopinavir/ritonavir with the herbal products echinacea, ginseng, and ginkgo biloba. Patients with HIV infection often take herbal products and dietary supplements in addition to their doctor-prescribed medicines to treat the disease, lessen the side effects of anti-viral drugs, and improve their overall well being. Alternative medicines such as these may, however, interfere with the elimination of lopinavir/ritonavir from the body, causing either higher or lower blood levels of these drugs than would be expected. This study will assess in healthy subjects any potential harms of taking echinacea, ginseng, or ginkgo biloba together with lopinavir/ritonavir. Healthy normal volunteers between 18 and 50 years of age may be eligible for this study. Candidates are screened with a history, physical examination, and blood tests, including an HIV test and a pregnancy test for women. Pregnant women are excluded from the study. Participants come to the NIH Clinical Center after fasting overnight for the following procedures: Visits 1 and 2: A catheter (plastic tube) is placed in an arm vein to collect blood samples. After the first sample is drawn, the subject takes 8 mg of midazolam syrup and two fexofenadine tablets. Midazolam is a sedative, and fexofenadine (Allegra) is a medicine used to treat allergies. Subjects are given breakfast an hour after taking the drugs. Blood samples are collected at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8 and 24 hours after taking the drugs to measure blood levels of fexofenadine. An extra sample is collected at the 4-hour mark to measure the midazolam level. The catheter is removed after the 8-hour blood draw and subjects are dismissed home. They return the following morning (visit 2) for the 24-hour blood draw. Visit 3: From 7 to 28 days after visit 1, subjects begin taking lopinavir/ritonavir capsules twice a day by mouth for a total of 29.5 days. On day 15 they return to the clinic for lopinavir/ritonavir blood levels as were done for fexofenadine, except that samples are collected once before breakfast and then at 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after the lopinavir/ritonavir dose. An extra sample is collected for routine tests. The catheter is removed after the 12-hour draw and the subject is dismissed home. The next morning, subjects begin taking one of the following: echinacea 500 mg 3 times a day; ginkgo biloba 120 mg twice a day; or ginseng 500 mg 3 times a day for 28 days. Visit 4: On the last day of taking lopinavir/ritonavir, subjects return to the clinic again for blood level measurements of these drugs as on visit 3, except that the catheter is removed and the subject dismissed home after the 8-hour blood draw. Visits 5 and 6: On the last day of taking the herbal supplement, subjects return to the clinic for repeat measurement of fexofenadine and midazolam levels, as described in visits 1 and 2. At the final visit (visit 6) an additional blood sample is collected for repeat laboratory testing. ...
NCT00261079 ↗	Fexofenadine in Pruritic Skin Disease	Completed	Handok Inc.	Phase 4	2005-04-01	Primary objective: - To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease Secondary objective: - To evaluate patient's satisfaction of Allegra treatment
NCT00261079 ↗	Fexofenadine in Pruritic Skin Disease	Completed	Handok Pharmaceuticals Co., Ltd.	Phase 4	2005-04-01	Primary objective: - To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease Secondary objective: - To evaluate patient's satisfaction of Allegra treatment
NCT00420082 ↗	A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber	Completed	Faes Farma, S.A.	Phase 2	2006-10-01	This is a randomized, double blind, active and placebo controlled, 4 way crossover study in patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20 mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber.
NCT00562120 ↗	A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge	Completed	Pfizer	Phase 2	2007-12-01	An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic rhinometry will be used to measure the congestion.

Clinical Trial Conditions for Allegra

Condition Name

Condition Name for Allegra
Intervention	Trials
Healthy	10
Seasonal Allergic Rhinitis	6
Allergic Rhinitis	5
Pruritus	2

Condition MeSH

Condition MeSH for Allegra
Intervention	Trials
Rhinitis, Allergic	16
Rhinitis	16
Rhinitis, Allergic, Seasonal	8
Rhinitis, Allergic, Perennial	2

Clinical Trial Locations for Allegra

Trials by Country

Trials by Country for Allegra
Location	Trials
United States	14
Canada	4
India	3
Japan	3
Brazil	1

Trials by US State

Trials by US State for Allegra
Location	Trials
New Jersey	3
North Dakota	2
West Virginia	2
California	1
Utah	1

Clinical Trial Progress for Allegra

Clinical Trial Phase

Clinical Trial Phase for Allegra
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	3
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Allegra
Clinical Trial Phase	Trials
Completed	30
Not yet recruiting	2
Recruiting	2

Clinical Trial Sponsors for Allegra

Sponsor Name

Sponsor Name for Allegra
Sponsor	Trials
Sanofi	8
Merck Sharp & Dohme Corp.	5
Dr. Reddy's Laboratories Limited	5

Sponsor Type

Sponsor Type for Allegra
Sponsor	Trials
Industry	30
Other	8
U.S. Fed	1

Clinical Trials, Market Analysis, and Projections for Allegra (Fexofenadine Hydrochloride)

Introduction to Allegra

Allegra, also known as fexofenadine hydrochloride, is a widely used antihistamine medication approved for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Efficacy and Safety

Clinical trials for Allegra have been extensive and have demonstrated its efficacy and safety. In two 4-week multicenter, randomized, double-blind, placebo-controlled clinical trials, fexofenadine hydrochloride significantly reduced total symptom scores for seasonal allergic rhinitis in patients aged 12 to 65 years. These symptoms included rhinorrhea, itchy nose/palate/throat, and itchy/watery/red eyes[4].

For pediatric patients, two 2-week multicenter trials involving 877 patients aged 6 to 11 years showed that fexofenadine hydrochloride doses of 15, 30, and 60 mg twice daily significantly reduced total symptom scores compared to placebo. However, no additional benefit was observed with the 60 mg dose over the 30 mg dose[4].

Pharmacokinetics and Duration of Action

The pharmacokinetic studies involved collecting plasma samples to measure the maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC). These studies helped in understanding the drug's absorption, distribution, and elimination. The onset of action for reducing total symptom scores was observed within 60 minutes to 3 hours after a single dose[4].

Safety Profile

The safety of Allegra was assessed through monitoring adverse events, vital signs, and urine pregnancy tests. The drug has been found to be well-tolerated, with minimal adverse effects. For instance, in one study, only one of five reports of headache was considered related to the study drug[1].

Market Analysis

Global Allergy Treatment Market

The global allergy treatment market, which includes Allegra, is projected to grow significantly. In 2017, the market was valued at $24.65 billion and is expected to reach $40.36 billion by 2025, growing at a CAGR of 6.3% from 2018 to 2025. This growth is driven by the increasing prevalence of allergic diseases such as asthma and rhinitis[2].

Distribution Channels

Retail pharmacies currently dominate the market, holding about half of the total share in 2017. However, online pharmacies are expected to grow at the fastest CAGR of 7.9% from 2018 to 2025 due to increased internet penetration and online sales of allergy medications[2].

Regional Market

North America holds the largest share of the allergy treatment market, driven by a well-established healthcare infrastructure and increased adoption of immunotherapy solutions. The Asia-Pacific region is expected to show the fastest growth, with a CAGR of 7.5% through 2025, due to the rising prevalence of allergic diseases in this region[2].

Antihistamine Market Trends

Growth Drivers

The antihistamine market, which includes Allegra, is expected to register a CAGR of 7.70% during the forecast period. Key drivers include the rising incidence of allergies and stomach disorders, as well as increasing research and development activities for novel dosage forms. For example, nearly one-third of American adults and over a quarter of American children suffer from seasonal allergies, eczema, or food allergies each year[5].

Regional Dominance

North America is anticipated to hold a significant share of the antihistamine market due to the high incidence of allergies, strong healthcare infrastructure, and government funding for research and development. The prevalence of allergic rhinitis and food allergies in the U.S. and Canada further supports this market growth[5].

Projections and Future Outlook

Market Size and Growth

Given the increasing prevalence of allergic diseases and the expanding healthcare infrastructure, the market for Allegra and other antihistamines is expected to continue growing. By 2025, the global allergy treatment market is projected to reach $40.36 billion, with the antihistamine segment contributing significantly to this growth[2].

Innovations and New Formulations

The future outlook for Allegra includes potential new formulations and delivery methods. For instance, the approval of Allegra Oral Suspension for pediatric patients has expanded the treatment options for children as young as 2 years old. Such innovations are likely to enhance patient compliance and satisfaction, further driving market growth[3].

Competitive Landscape

The market for allergy treatments is competitive, with several key players. Sanofi, the manufacturer of Allegra, continues to play a significant role in this market. The company's focus on research and development, along with strategic marketing, will be crucial in maintaining its market position[3].

Key Takeaways

• Clinical Efficacy: Allegra has demonstrated significant efficacy in reducing symptoms of seasonal allergic rhinitis and chronic idiopathic urticaria in both adults and children.
• Market Growth: The global allergy treatment market and the antihistamine market are expected to grow at a CAGR of 6.3% and 7.70%, respectively, driven by increasing prevalence of allergic diseases.
• Regional Dominance: North America holds the largest share of the market, while the Asia-Pacific region is expected to show the fastest growth.
• Innovations: New formulations, such as Allegra Oral Suspension, are expanding treatment options and enhancing patient compliance.

FAQs

Q: What are the approved indications for Allegra?

A: Allegra is approved for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older, as well as for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older[1].

Q: What is the typical dosage of Allegra for pediatric patients?

A: For pediatric patients, Allegra Oral Suspension is approved in doses of 30 mg twice daily for patients 2 to 11 years old and 15 mg twice daily for patients 6 months to 2 years old[3].

Q: How quickly does Allegra start to reduce allergy symptoms?

A: The onset of action for Allegra in reducing total symptom scores is observed within 60 minutes to 3 hours after a single dose[4].

Q: What are the primary distribution channels for allergy medications like Allegra?

A: Retail pharmacies currently dominate the market, but online pharmacies are expected to grow at the fastest rate due to increased internet penetration[2].

Q: Which region is expected to show the fastest growth in the allergy treatment market?

A: The Asia-Pacific region is expected to show the fastest growth, with a CAGR of 7.5% through 2025, due to the rising prevalence of allergic diseases in this region[2].

Sources

1. Allegra 4144 - Sanofi U.S. - Clinical Trials Results Database Proposal[1]
2. Allergy Treatment Market to Reach $40.36 Bn, Globally, by 2025 - Allied Market Research[2]
3. FDA approves ALLEGRA® (fexofenadine hydrochloride) Oral Suspension - Sanofi U.S.[3]
4. ALLEGRA® (fexofenadine hydrochloride) Capsules and Tablets - FDA Label[4]
5. Antihistamine Market Size & Share Analysis - Mordor Intelligence[5]