CLINICAL TRIALS PROFILE FOR ALLEGRA ALLERGY

All Clinical Trials for Allegra Allergy

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.
NCT00636870 ↗	Fexofenadine (Allegra®) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine	Completed	Sanofi	Phase 4	2003-02-01	To evaluate the single-dose and steady-state pharmacokinetics of desloratadine and fexofenadine in desloratadine slow metabolizers. To evaluate the safety and tolerability of desloratadine compared to fexofenadine following single and multiple oral doses administered to desloratadine slow metabolizers.
NCT00637585 ↗	Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine	Completed	Sanofi	Phase 4	2002-12-01	To examine the relative potency, onset of action and duration of action of fexofenadine HCl 180 mg (ALLEGRA) and desloratadine 5 mg (CLARINEX) as compared to placebo on skin wheals and flares induced by histamine.

Clinical Trial Conditions for Allegra Allergy

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Allegra Allergy

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Allegra Allergy

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Allegra Allergy

Sponsor Name

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

Sponsor Type

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

ALLEGRA Allergy: Clinical Trials, Market Analysis, and Projections

Introduction to ALLEGRA

ALLEGRA, known generically as fexofenadine hydrochloride, is a widely used antihistamine for the treatment of allergic conditions, particularly seasonal allergic rhinitis. Here, we delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Adult Studies

Clinical trials have consistently demonstrated the efficacy of ALLEGRA in reducing symptoms of seasonal allergic rhinitis. In a double-blind, placebo-controlled trial involving 863 patients aged 12 to 65 years, fexofenadine hydrochloride at a dose of 180 mg once daily significantly reduced total symptom scores compared to placebo. These symptoms included rhinorrhea, itchy nose/palate/throat, and itchy/watery/red eyes[1].

Pediatric Studies

In pediatric patients aged 6 to 11 years, two 2-week multicenter, randomized, placebo-controlled, double-blind trials were conducted. These trials involved 877 pediatric patients and showed that doses of 15, 30, and 60 mg twice daily significantly reduced total symptom scores. However, a dose-response relationship was not observed, and the 60 mg twice daily dose did not provide additional benefit over the 30 mg twice daily dose[1].

Onset of Action

The onset of action for ALLEGRA has been observed within 1 to 3 hours following administration. In one clinical trial, the onset of action was seen as early as 60 minutes after a single 60 mg dose, excluding nasal congestion[1].

Safety and Tolerability

A meta-analysis of clinical trials has shown that fexofenadine maintains a beneficial profile in terms of efficacy and safety. The frequency of adverse events (AEs) was similar to that of the placebo group, indicating a good safety profile for fexofenadine[4].

Market Analysis

Current Market Size and Growth

The allergy treatment market, which includes medications like ALLEGRA, was valued at USD 22.8 billion in 2024. This market is projected to grow substantially, reaching USD 42.7 billion by 2034, with a compound annual growth rate (CAGR) of 7.2% from 2024 to 2034[2].

Drivers of Market Growth

Several factors are driving the growth of the allergy treatment market:

• Increasing Allergy Prevalence: The rise in allergic conditions globally, particularly in developed countries, is a significant driver.
• Advancements in Treatments: Innovations in allergy treatments, including antihistamines, corticosteroids, and immunotherapy, are contributing to market expansion.
• Growing Awareness: Increased awareness among individuals about the availability of better treatment options is driving demand.
• Personalized Healthcare: The shift towards more personalized healthcare options, including targeted therapies, is creating new market opportunities[2].

Regional Analysis

• North America: Expected to maintain a dominant market share due to advanced healthcare systems and high allergy prevalence.
• Europe: Growth driven by increasing awareness, significant investments in healthcare, and rising allergic disease prevalence.
• Asia-Pacific: Anticipated to witness the highest growth rate due to the growing population and rising government investments in the healthcare sector[2][3].

Market Segments

Medications

Antihistamines, corticosteroids, and biologic drugs are expected to remain dominant in the allergy treatment market. The biologics segment is forecasted to experience the highest CAGR due to the increasing focus on targeted therapies[2].

Immunotherapy

The allergy immunotherapy segment is expected to grow significantly due to its ability to provide long-term relief from allergies through desensitization. Sublingual immunotherapy and allergy vaccines are seeing increased adoption[2].

Diagnostics

Diagnostic tools for allergy identification, such as skin prick tests, blood tests, and molecular diagnostics, will play a key role in personalized treatment plans and support overall market growth[2].

Competitive Landscape

The allergy treatment market is highly competitive, with several key players investing in research and development. For instance, in February 2024, Genentech received FDA approval for its anti-allergy injection called Xolair, which has been crucial for the company's market position[3].

Future Projections

Market Size

The allergy treatment market, including ALLEGRA, is projected to reach USD 42.7 billion by 2034. This growth is driven by the increasing prevalence of allergic conditions and advancements in treatment options[2].

Innovation and Personalization

The market is expected to see significant innovation, particularly in targeted therapies and personalized healthcare options. Companies that invest in research, development, and patient-centric solutions will be best positioned for long-term success[2].

Regional Growth

Asia-Pacific is anticipated to witness the highest growth rate, driven by the growing population and increasing government investments in healthcare. North America and Europe will also continue to be major contributors to the market growth[2][3].

Key Takeaways

• Clinical Efficacy: ALLEGRA has demonstrated significant efficacy in reducing symptoms of seasonal allergic rhinitis in both adults and children.
• Market Growth: The allergy treatment market is projected to grow to USD 42.7 billion by 2034, driven by increasing allergy prevalence and advancements in treatments.
• Regional Analysis: North America, Europe, and Asia-Pacific will be key regions driving market growth.
• Innovation: Targeted therapies and personalized healthcare options will be significant drivers of market expansion.

FAQs

What is the current market size of the allergy treatment market?

The allergy treatment market was valued at USD 22.8 billion in 2024[2].

What is the projected growth rate of the allergy treatment market?

The market is expected to grow at a CAGR of 7.2% from 2024 to 2034[2].

What are the key drivers of the allergy treatment market growth?

Key drivers include increasing allergy prevalence, advancements in treatments, growing awareness, and the shift towards personalized healthcare[2].

Which region is expected to witness the highest growth rate in the allergy treatment market?

The Asia-Pacific region is anticipated to witness the highest growth rate due to the growing population and increasing government investments in healthcare[2][3].

What is the role of ALLEGRA in the allergy treatment market?

ALLEGRA is a widely used antihistamine that has demonstrated efficacy in reducing symptoms of seasonal allergic rhinitis and is expected to continue playing a significant role in the market[1][4].

Sources

1. ALLEGRA® (fexofenadine hydrochloride) Capsules and Tablets - FDA Label[1]
2. The Allergy Treatment Market is Set to Reach USD 42.7 Billion by 2034 - GlobeNewswire[2]
3. Allergy Treatment Market Size and Share Projected to Surpass USD 34.9 Billion by 2034 - GlobeNewswire[3]
4. Update meta-analysis on the efficacy and safety issues of fexofenadine - PubMed[4]