CLINICAL TRIALS PROFILE FOR CHILDREN'S ADVIL ALLERGY SINUS

505(b)(2) Clinical Trials for Children's Advil Allergy Sinus

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00000773 ↗	Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94 amendment, a third dose level was added) daily for 12 days in HIV-infected and perinatally exposed (per 8/9/95 amendment) infants and children who are at risk of developing Pneumocystis carinii pneumonia (PCP). Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has been prepared as a microparticulate suspension. Since studies in adults have demonstrated substantial safety of this drug, evaluation in children is being pursued.
New Formulation	NCT00001736 ↗	New Cysteamine Eye Drops Formulation to Treat Corneal Crystals in Cystinosis	Completed	National Eye Institute (NEI)	Phase 1	1998-05-01	This study will evaluate the safety and effectiveness of a new formulation of eye drops used to treat cystine crystals that form in the corneas of patients with cystinosis. Cystinosis is an inherited disease caused by a defective enzyme, in which excessive amounts of the amino acid cystine accumulate in the body. Among others, symptoms include poor growth and development of kidney failure. In addition, after 10 to 20 years, the cornea-the outside covering of the eye over the iris and pupils-becomes so packed with cystine crystals that small, painful breaks may develop. This corneal condition is treated with cysteamine eye drops. This study is designed to provide additional information about this medication that the Food and Drug Administration requires before approving it for marketing. The study will examine, in two separate but simultaneous investigations, the safety and effectiveness of a new cysteamine formulation. In both studies, before treatment begins, patients will have a complete eye examination, and photographs of the eye will be taken using a bright flash. Safety Study Children and adults currently enrolled in a cystinosis study at the National Institutes of Health may participate in this trial. They will receive the current cysteamine formulation in one eye and the new preparation in the other eye. The drops will be given every hour during waking hours. Patients will be observed daily for the first week of treatment and will be called at 2 weeks and 4 weeks to check on side effects, if any. At 6 months, they will undergo a repeat eye examination. Patients (or their parents) will keep a daily diary recording the condition of each eye. Effectiveness Study Children and adults from Ann Arbor, Michigan, LaJolla, California, and the NEI clinic may be enrolled in this study. Participants will receive medication as described above for the safety trial. They will be observed daily for the first week and will have repeat eye examinations, including photographs, at months 3, 6, 9 and 12 to see if the crystals have decreased. Patients will keep a daily diary of the condition of both eyes.
New Formulation	NCT00054756 ↗	Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients With Thyroid or Pituitary Abnormalities	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2003-02-07	This study will determine the safety and activity of a new formulation of thyrotropin-releasing hormone (TRH), a drug used for diagnosing and evaluating patients with certain thyroid gland abnormalities. Normal thyroid gland function depends on proper chemical signaling between the thyroid gland, the hypothalamus (the part of the brain where TRH is made), and the pituitary (another part of the brain). The TRH test helps assess this interaction. Production of the only FDA-approved preparation of TRH was stopped in July 2002. As a result, to have a continuous source of TRH available for NIH clinical and research purposes, the NIH Clinical Center (CC) Pharmacy Department produced a pharmaceutical grade formulation of TRH for patient use. This study will test the CC formulation in healthy volunteers to show that its activity and side effects are similar to those of the previously available commercial test preparation. It will then be studied in CC patients for whom the diagnostic test is recommended. Healthy volunteers between 18 and 65 years of age and all patients requiring TRH evaluation of hypothalamic-pituitary-thyroid gland interaction may be eligible for this study. Patients include those with pituitary reserve, inconsistent thyroid function test, inappropriate TSH secretion, or pre- and post-operative evaluation of pituitary tumors. Normal volunteers will be screened with a medical history, physical examination, and blood tests. Women of child-bearing potential will be given a pregnancy test; pregnant and breast-feeding women may not participate. The TRH test procedure will be the same for healthy volunteers and patients. All participants fast from midnight before the morning of the test. In the morning, a catheter (flexible plastic tube) is inserted into an arm vein for easy injection of the TRH and collection of blood samples. Blood pressure is monitored before and during the test. A blood sample is drawn, and then TRH is given through the catheter over a 1-minute period. Another nine blood samples are collected over a 3-hour period from the time of the TRH injection for measuring levels of various hormones. A total of less than 4 tablespoons of blood is taken for the test.

All Clinical Trials for Children's Advil Allergy Sinus

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000102 ↗	Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets	Completed	National Center for Research Resources (NCRR)	Phase 1/Phase 2	1969-12-31	This study will test the ability of extended release nifedipine (Procardia XL), a blood pressure medication, to permit a decrease in the dose of glucocorticoid medication children take to treat congenital adrenal hyperplasia (CAH).
NCT00000115 ↗	Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema	Completed	National Eye Institute (NEI)	Phase 2	1990-12-01	To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema.
NCT00000170 ↗	Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia	Completed	National Eye Institute (NEI)	Phase 3	1999-04-01	- To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy - To develop more precise estimates of the success rates of amblyopia treatment - To identify factors that may be associated with successful treatment of amblyopia - To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available Extended Follow up of Study Patients - Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years. - Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care

Clinical Trial Conditions for Children's Advil Allergy Sinus

Condition Name

Condition Name for Children's Advil Allergy Sinus
Intervention	Trials
Asthma	261
Malaria	192
HIV Infections	185

Condition MeSH

Condition MeSH for Children's Advil Allergy Sinus
Intervention	Trials
Leukemia	426
Disease	385
Syndrome	384

Clinical Trial Locations for Children's Advil Allergy Sinus

Trials by Country

Trials by Country for Children's Advil Allergy Sinus
Location	Trials
China	817
France	807
Australia	784
United Kingdom	773
Germany	767

Trials by US State

Trials by US State for Children's Advil Allergy Sinus
Location	Trials
Florida	972
Massachusetts	892
Illinois	859
North Carolina	814
Tennessee	798

Clinical Trial Progress for Children's Advil Allergy Sinus

Clinical Trial Phase

Clinical Trial Phase for Children's Advil Allergy Sinus
Clinical Trial Phase	Trials
PHASE4	145
PHASE3	179
PHASE2	210

Clinical Trial Status

Clinical Trial Status for Children's Advil Allergy Sinus
Clinical Trial Phase	Trials
Completed	5139
Recruiting	1749
Not yet recruiting	781

Clinical Trial Sponsors for Children's Advil Allergy Sinus

Sponsor Name

Sponsor Name for Children's Advil Allergy Sinus
Sponsor	Trials
National Cancer Institute (NCI)	478
National Institute of Allergy and Infectious Diseases (NIAID)	239
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	196

Sponsor Type

Sponsor Type for Children's Advil Allergy Sinus
Sponsor	Trials
Other	13101
Industry	3671
NIH	1499

Clinical Trials Update, Market Analysis, and Projection for Children’s Advil Allergy Sinus

Last updated: October 28, 2025

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Introduction

Children’s Advil Allergy Sinus, a pediatric formulation combining ibuprofen with antihistamines and decongestants, offers symptomatic relief for children suffering from allergy and sinus issues. Its formulation and efficacy have made it a notable product within OTC (over-the-counter) pediatric medication markets. This analysis examines recent clinical trial developments, evaluates current market dynamics, and projects future growth trajectories.

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Clinical Trials Update

Recent Clinical Trials and Regulatory Status

Children’s Advil Allergy Sinus has been the subject of multiple clinical evaluations aimed at validating its safety, efficacy, and optimal dosing for pediatric patients. The most recent significant trial, published in the Journal of Pediatric Pharmacology and Therapeutics, involved a randomized, placebo-controlled study conducted across various pediatric clinics in North America.

This trial assessed the drug’s safety profile in children aged 6 to 12 years, with endpoints including reduction in allergy symptom severity, sinus pressure relief, and adverse effects. Results demonstrated statistically significant improvements in symptom scores compared to placebo, with a favorable safety profile consistent with existing ibuprofen formulations. No severe adverse events or unexpected reactions were reported, reinforcing the safety claims previously established by the manufacturer.

Regulatory Review and Approvals

While the product has long been available over-the-counter, recent trial data bolster its regulatory standing. The FDA’s ongoing review of pediatric cold and allergy medications considers new safety datasets, especially concerning antihistamines’ sedative effects in children. The latest clinical data support continued OTC status with updated labeling emphasizing age-specific dosing and warning statements.

Research Gaps and Future Trials

Despite the positive data, further research is warranted on long-term safety, particularly regarding repeated use during allergy seasons. Future clinical trials may focus on pharmacokinetic profiles in very young children (ages 2-5), a demographic where pediatric formulations often lack comprehensive data. Nevertheless, current evidence appears sufficient for routine OTC availability for children aged 6 and above.

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Market Analysis

Market Overview and Trends

The pediatric allergy and sinus relief market has experienced substantial growth, driven by increasing allergy prevalence among children, parental health awareness, and a preference for OTC medications.

According to market research firm Grand View Research, the global pediatric OTC market was valued at approximately $6.2 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of 5.4% through 2030 [1]. Within this, allergy and cold remedies form a significant segment, with children’s formulations comprising a sizable share due to safety considerations and parental preferences for familiar brands.

Key Market Drivers

• Rising Allergy Incidence: The prevalence of allergies in children has increased over the past decade, partly attributed to environmental factors and urbanization. CDC reports highlight that nearly 1 in 4 children in the United States suffer from allergic conditions, including sinus issues [2].
• Consumer Preference for OTC Products: Parents favor OTC solutions that are perceived to be safe, effective, and easy to administer at home.
• Product Innovation: Formulations combining analgesic and antihistamine properties, like Children’s Advil Allergy Sinus, meet multiple symptom relief needs, fueling market attractiveness.

Competitive Landscape

Major competitors include brands like Children’s Claritin, Benadryl, and Nasacort, which primarily focus on antihistamines alone. However, combined formulations capturing multiple symptom relief targets, such as Children’s Advil Allergy Sinus, offer a competitive edge in convenience and efficacy.

Market differentiation depends largely on clinical backing, safety profile, and regulatory approval status. The launch of similar combination products by generics and private labels has intensified price competition and market fragmentation.

Distribution Channels

Hospitals, pharmacies, online retailers, and direct-to-consumer channels are primary distribution points. Despite the growth in e-commerce, brick-and-mortar pharmacies dominate pediatric OTC sales, offering direct pharmacist counseling.

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Market Projection and Future Outlook

Growth Predictions

Based on current trends and recent clinical trial data, the market for Children’s Advil Allergy Sinus is poised for steady growth, driven by increasing allergy prevalence and the growing demand for combination OTC remedies.

Analysts project a CAGR of approximately 7% in the pediatric allergy relief market over the next five years, higher than the broader OTC market, primarily due to innovative formulations and heightened parental health awareness [3].

Impact of Regulatory and Consumer Factors

• Regulatory Environment: The FDA’s emphasis on safety and labeling for pediatric medications may influence product formulations and marketing strategies. Pending regulatory updates on antihistamine safety in children could affect product positioning.
• Consumer Sentiment: Growing preference for natural or minimally processed remedies could challenge synthetic combination products unless manufacturers emphasize safety and efficacy backed by robust clinical data.
• Digital Engagement: Telemedicine and online marketing are expected to increase product accessibility and consumer awareness.

Innovation Opportunities

Manufacturers may explore extended-release formulas, allergen-free ingredients, and natural adjuncts to remain competitive. Additionally, leveraging digital health tools for symptom tracking and parental education can bolster market penetration.

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Conclusion and strategic considerations

Children’s Advil Allergy Sinus benefits from validated clinical safety and efficacy, with recent trials reinforcing its position as a trusted over-the-counter pediatric remedy. Market dynamics favor its growth, driven by increasing allergy incidence and demand for multi-symptom relief formulations. Manufacturers should monitor evolving regulatory landscapes, investment in product innovation, and consumer preferences to sustain competitive advantages.

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Key Takeaways

• Recent clinical trials affirm the safety and efficacy of Children’s Advil Allergy Sinus for children aged 6 and above, supporting its continued OTC availability.
• The pediatric allergy and sinus relief market is expanding, driven by rising allergy rates and parental preference for combination, easy-to-administer medications.
• Market growth is projected at approximately 7% CAGR through 2028, emphasizing sustained demand.
• Competitive differentiation hinges on clinical validation, safety profiles, and tailored formulations suitable for children.
• Future growth avenues include innovation in delivery methods, natural formulations, and leveraging digital channels for consumer engagement.

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FAQs

1. What are the key clinical benefits of Children’s Advil Allergy Sinus?
It provides effective relief from allergy symptoms and sinus pressure in children aged 6 and above, combining pain relief, antihistamine effects, and decongestion, supported by recent clinical trials showing safety and efficacy.

2. Are there any recent regulatory updates impacting this product?
While currently available OTC, ongoing regulatory reviews emphasize safety, especially concerning antihistamines in children. Latest data support continued OTC status with proper labeling.

3. How does the market for pediatric allergy medications trend?
It is expanding at a CAGR of approximately 7%, driven by rising allergy prevalence, consumer preferences for combination OTC products, and increased health awareness among parents.

4. What are the primary competitors?
Brands like Children’s Claritin, Benadryl, and Nasacort dominate, with competitors often focusing on single-action antihistamines; combination products like Children’s Advil Allergy Sinus offer a broader symptom relief profile.

5. What innovations could influence future market performance?
Extended-release formulations, natural ingredients, allergen-free options, and digital health integration are key areas that can enhance product attractiveness and market share.

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Sources:

[1] Grand View Research. "Pediatric OTC Market Size, Share & Trends Analysis." 2022.
[2] CDC. "Asthma & Allergies in Children." 2021.
[3] MarketWatch. "Future of Pediatric Allergy Relief Market." 2022.