CLINICAL TRIALS PROFILE FOR ADVIL CONGESTION RELIEF

505(b)(2) Clinical Trials for Advil Congestion Relief

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
OTC	NCT00487032 ↗	Differential Adrenoreceptor Mediated Tachyphylaxis and Upregulation	Completed	Brian J Lipworth	Phase 4	2008-05-01	The investigators wish to evaluate the onset of tolerance to nasal decongestants like oxymetazoline (available over the counter) and the mechanism of tolerance particularly with differential effects on alpha 1 and alpha 2 adrenoreceptors on the nose. The investigators will 'tease' out by using an alpha 1 blocker called Prazosin. The investigators hypothesize that alpha 1 receptors mediate arterial constriction and this will be captured by measuring nasal blood flow. The investigators also hypothesize that alpha 2 receptors mediate venous sinusoid constriction and this the investigators will capture by airflow parameters like Peak Nasal Inspiratory Flow, Rhinomanometry, Oscillometric indices etc.
OTC	NCT01448057 ↗	Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu	Completed	Novartis	Phase 3	2013-07-01	The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).
New Formulation	NCT03339726 ↗	Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold	Terminated	Johnson & Johnson Consumer Inc. (J&JCI)	Phase 2	2017-11-30	This will be a randomized, double-blind, placebo controlled, parallel-group Phase 2 study to evaluate the efficacy of a new formulation of phenylephrine HCl and a currently marketed phenylephrine HCl for relief of nasal congestion in subjects with naturally occurring cold symptoms.

All Clinical Trials for Advil Congestion Relief

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00115622 ↗	Study In Adults And Adolescents With Seasonal Allergic Rhinitis	Completed	GlaxoSmithKline	Phase 3	2004-12-01	The purpose of the study is to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
NCT00118729 ↗	Study In Adolescent And Adult Subjects 12 Years Of Age And Older With Seasonal Allergic Rhinitis To Assess Onset of Action	Completed	GlaxoSmithKline	Phase 3	2005-04-01	Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes. The purpose of this study is to evaluate the onset of action of an investigational nasal spray, GW685698X aqueous nasal spray, versus vehicle placebo nasal spray in the treatment of seasonal allergic rhinitis caused by ragweed following a single dose of treatment in controlled pollen concentrations in an allergen challenge chamber.
NCT00124137 ↗	Ultrafiltration Versus Intravenous (IV) Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: (UNLOAD)	Completed	CHF Solutions	N/A	2004-04-01	The purpose of this study is to compare patients who are suffering from heart failure and who are fluid overloaded to determine if ultrafiltration (UF) can remove more of the extra fluid as measured by weight loss while in the hospital and improve the patient's breathing.
NCT00124137 ↗	Ultrafiltration Versus Intravenous (IV) Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: (UNLOAD)	Completed	Nuwellis, Inc.	N/A	2004-04-01	The purpose of this study is to compare patients who are suffering from heart failure and who are fluid overloaded to determine if ultrafiltration (UF) can remove more of the extra fluid as measured by weight loss while in the hospital and improve the patient's breathing.
NCT00197262 ↗	Once-Daily Investigational Nasal Spray In Adults And Adolescents With Seasonal Allergic Rhinitis (SAR)	Completed	GlaxoSmithKline	Phase 3	2005-08-01	Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as (hay fever), it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes. The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with seasonal allergic rhinitis (SAR) caused by ragweed pollen.
NCT00224523 ↗	Long Term Safety Of GW685698X Via Nasal Biopsy	Completed	GlaxoSmithKline	Phase 3	2005-09-01	Long term safety (52 weeks) of GW685698X on the nasal mucosa via nasal biopsy with an active control group (Nasonex®) and a healthy volunteers control group in subjects 18 years old with perennial allergic rhinitis . Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. Perennial allergic rhinitis is triggered by house dust mites, animal dander, etc., possibly causing symptoms year-round including nasal congestion, rhinorrhea and/or nasal itching.

Clinical Trial Conditions for Advil Congestion Relief

Condition Name

Condition Name for Advil Congestion Relief
Intervention	Trials
Heart Failure	33
Allergic Rhinitis	28
Seasonal Allergic Rhinitis	14
Acute Heart Failure	14

Condition MeSH

Condition MeSH for Advil Congestion Relief
Intervention	Trials
Rhinitis	79
Heart Failure	79
Rhinitis, Allergic	67
Rhinitis, Allergic, Seasonal	32

Clinical Trial Locations for Advil Congestion Relief

Trials by Country

Trials by Country for Advil Congestion Relief
Location	Trials
United States	501
China	40
Spain	35
Italy	32
Canada	31

Trials by US State

Trials by US State for Advil Congestion Relief
Location	Trials
Texas	31
North Carolina	23
California	22
Missouri	20
New York	20

Clinical Trial Progress for Advil Congestion Relief

Clinical Trial Phase

Clinical Trial Phase for Advil Congestion Relief
Clinical Trial Phase	Trials
Phase 4	81
Phase 3	98
Phase 2/Phase 3	14

Clinical Trial Status

Clinical Trial Status for Advil Congestion Relief
Clinical Trial Phase	Trials
Completed	164
Recruiting	41
Not yet recruiting	40

Clinical Trial Sponsors for Advil Congestion Relief

Sponsor Name

Sponsor Name for Advil Congestion Relief
Sponsor	Trials
GlaxoSmithKline	17
Merck Sharp & Dohme Corp.	15
Bayer	9

Sponsor Type

Sponsor Type for Advil Congestion Relief
Sponsor	Trials
Other	315
Industry	168
NIH	8

Advil Congestion Relief: Clinical Trials, Market Analysis, and Projections

Introduction

Advil Congestion Relief is a medication designed to tackle the symptoms of nasal congestion, headaches, and other related ailments, particularly during the cold and flu season. This article will delve into the clinical aspects, market analysis, and future projections of this product.

Clinical Trials and Efficacy

Efficacy of Phenylephrine

A crucial component of Advil Congestion Relief is phenylephrine, a decongestant that has been under scrutiny for its efficacy when taken orally. Recent findings from an FDA advisory panel indicate that phenylephrine is ineffective as an oral decongestant, contrary to its effectiveness when administered directly to the nasal passages via nasal sprays[2].

Clinical Implications

Despite the oral form of phenylephrine being deemed ineffective, Advil Congestion Relief combines it with ibuprofen and other ingredients to provide relief from sinus pressure, nasal swelling, and headaches. The combination of ibuprofen and phenylephrine in Advil Congestion Relief is designed to address multiple symptoms, but the efficacy of the oral decongestant component remains a topic of debate.

Market Analysis

Market Size and Growth

The Advil market, which includes various formulations such as Advil Congestion Relief, was valued at $21.01 billion in 2023 and is projected to reach $31.03 billion by 2031, growing at a CAGR of 5.1% during the forecast period[3].

Product Types and Applications

Advil Congestion Relief is part of a broader product line that includes tablets, liquid gels, caplets, and chewable tablets. The market is segmented by application, with pain relief being the primary focus, including subcategories such as headache, muscle pain, and back pain[3].

Distribution and Accessibility

The availability of Advil Congestion Relief has been enhanced by the expansion of distribution channels, including pharmacies, supermarkets, and online retailers. This increased accessibility has contributed to the market growth, especially with the rise of e-commerce post-COVID-19[3].

Market Drivers

Increasing Awareness of Pain Management

The growing consumer knowledge of pain management techniques has driven the demand for over-the-counter pain relievers like Advil Congestion Relief. Public health campaigns, educational programs, and advice from medical professionals have emphasized effective pain management, leading to increased trust in reliable OTC remedies[3].

Rising Chronic Illness Rates

The prevalence of chronic illnesses such as fibromyalgia, arthritis, and other pain-related ailments has increased the need for pain management treatments. As the global population ages, the demand for easily accessible and efficient OTC drugs like Advil Congestion Relief continues to rise[3].

Market Challenges

Competition from Alternatives

The market for Advil Congestion Relief faces significant competition from natural and herbal medicines, generics, and other branded medications that offer comparable effectiveness at lower costs. This competition forces companies to innovate and reduce prices to maintain market share and brand loyalty[3].

Sensitivity to Price

Consumers are increasingly price-sensitive, which can impact the sales volume and brand loyalty of Advil Congestion Relief. The growing marketing activities of alternative pain relievers may shift consumer preferences, making it challenging for Advil to sustain its market position[3].

Projections and Future Outlook

Global Ibuprofen Market

The global ibuprofen market, which includes Advil Congestion Relief, is expected to grow from $1.43 billion in 2023 to $1.76 billion by 2032, at a CAGR of 2.44%. This growth is driven by factors such as rising urbanization, increasing public awareness of chronic diseases, and growing healthcare spending[5].

Regional Market Trends

The Asia Pacific region is the largest market for ibuprofen, while North America is expected to be the fastest-growing market during the forecast period. This regional growth is influenced by demographic changes, healthcare spending, and consumer preferences for OTC medications[5].

Key Takeaways

• Efficacy Debate: The oral form of phenylephrine in Advil Congestion Relief is deemed ineffective, but the combination with ibuprofen provides relief from multiple symptoms.
• Market Growth: The Advil market is projected to grow significantly, driven by increasing awareness of pain management and rising chronic illness rates.
• Distribution and Accessibility: Expanded distribution channels have increased the availability of Advil Congestion Relief.
• Competition and Price Sensitivity: The market faces competition from alternatives and is sensitive to price, requiring continuous innovation and competitive pricing.
• Future Outlook: The global ibuprofen market, including Advil Congestion Relief, is expected to grow at a CAGR of 2.44% from 2023 to 2032.

FAQs

Q: What are the main ingredients in Advil Congestion Relief?

A: Advil Congestion Relief contains ibuprofen, phenylephrine, and sometimes antihistamines like chlorpheniramine maleate[4].

Q: Is phenylephrine effective as an oral decongestant?

A: No, recent findings indicate that phenylephrine is ineffective as an oral decongestant but works when administered directly to the nasal passages[2].

Q: What are the common applications of Advil Congestion Relief?

A: It is used for pain relief, headaches, muscle pain, back pain, nasal congestion, and sinus pressure[3][4].

Q: How is the market for Advil Congestion Relief expected to grow?

A: The market is projected to grow at a CAGR of 5.1% from 2023 to 2031, driven by increasing awareness of pain management and rising chronic illness rates[3].

Q: What are the main challenges facing the Advil Congestion Relief market?

A: The market faces competition from natural and herbal medicines, generics, and other branded medications, as well as consumer price sensitivity[3].

Sources

1. Pfizer Launches New Advil® Congestion Relief and Offers 100 Holiday Shoppers Literal Decongestion From Black Friday Crowds - Pfizer Press Release.
2. Why are ineffective oral decongestants still on store shelves? - Harvard Gazette.
3. Advil Market Size, Share, Trends, Opportunities And Forecast - Verified Market Research.
4. Advil Allergy & Congestion Relief - eMPR.
5. Global Ibuprofen Market Size, Top Share, CAGR of 2.44%, Report - Straits Research.