CLINICAL TRIALS PROFILE FOR CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

All Clinical Trials for chlorpheniramine maleate; pseudoephedrine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01293201 ↗	Trial of STAHIST in Seasonal Allergic Rhinitis	Completed	Magna Pharmaceuticals, Inc.	Phase 3	2011-03-01	The overall development plan is to show that the combination of tried-and-proven decongestant/antihistamine ingredients (pseudoephedrine hydrochloride and chlorpheniramine maleate), plus a very small amount of belladonna alkaloids (.24 mg atropine sulfate) is a comprehensive, safe and effective B.I.D. drug treatment regimen, indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Treated symptoms include nasal congestion, sneezing, rhinorrhea, itchy nose, itchy/watery eyes, and post nasal drip syndrome [reduction in tickly cough (acute or chronic), mucus in the back of the throat, sore throat, and hoarseness]. Considering the favorable safety and efficacy results of Phase 1 and Phase 2, the purpose of Phase 3 is to assess and compare the safety and efficacy of the study drug in a larger group comparatively with a placebo control group. Objectives: A) To report and compare total symptom scores (TSS) by SAR subjects rating the efficacy of STAHIST vs. placebo in relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over the two-week study period. B) Report any side effects or adverse drug reactions and rate the severity of any incident. C) Compare and report each symptom score, total nasal symptom scores (TNSS), and post-nasal drip symptom scores (PND-S) between the two study arms.
NCT02246166 ↗	The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.	Completed	Sino-American Tianjin Smith Kline & French Laboratories Ltd	Phase 4	2015-01-01	This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.
NCT02246166 ↗	The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.	Completed	GlaxoSmithKline	Phase 4	2015-01-01	This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.

Clinical Trial Conditions for chlorpheniramine maleate; pseudoephedrine hydrochloride

Condition Name

Condition Name for chlorpheniramine maleate; pseudoephedrine hydrochloride
Intervention	Trials
Common Cold	1
Seasonal Allergic Rhinitis	1

Condition MeSH

Condition MeSH for chlorpheniramine maleate; pseudoephedrine hydrochloride
Intervention	Trials
Rhinitis, Allergic	1
Rhinitis	1
Common Cold	1
Rhinitis, Allergic, Seasonal	1

Clinical Trial Locations for chlorpheniramine maleate; pseudoephedrine hydrochloride

Trials by Country

Trials by Country for chlorpheniramine maleate; pseudoephedrine hydrochloride
Location	Trials
United States	6
China	1

Trials by US State

Trials by US State for chlorpheniramine maleate; pseudoephedrine hydrochloride
Location	Trials
Texas	1
South Carolina	1
Ohio	1
Kentucky	1
Indiana	1

Clinical Trial Progress for chlorpheniramine maleate; pseudoephedrine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for chlorpheniramine maleate; pseudoephedrine hydrochloride
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for chlorpheniramine maleate; pseudoephedrine hydrochloride
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for chlorpheniramine maleate; pseudoephedrine hydrochloride

Sponsor Name

Sponsor Name for chlorpheniramine maleate; pseudoephedrine hydrochloride
Sponsor	Trials
Magna Pharmaceuticals, Inc.	1
Sino-American Tianjin Smith Kline & French Laboratories Ltd	1
GlaxoSmithKline	1

Sponsor Type

Sponsor Type for chlorpheniramine maleate; pseudoephedrine hydrochloride
Sponsor	Trials
Industry	2
Other	1

Chlorpheniramine maleate; pseudoephedrine hydrochloride Market Analysis and Financial Projection

Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Chlorpheniramine maleate and pseudoephedrine hydrochloride are commonly used in combination to treat various allergic and respiratory conditions. This article provides an update on clinical trials, market analysis, and projections for these medications.

Clinical Trials Update

Current and Ongoing Trials

Clinical trials involving chlorpheniramine maleate and pseudoephedrine hydrochloride are ongoing, focusing on their efficacy and safety in different patient populations. For instance, a clinical trial (NCT05720455) is investigating the use of pseudoephedrine and chlorpheniramine in patients with seasonal allergic rhinitis (SAR) who are 12 years of age and older. This trial aims to assess the therapeutic effects and safety profile of this combination in a specific demographic[4].

Bioavailability Studies

Previous studies have compared the bioavailability of chlorpheniramine and pseudoephedrine from sustained-action capsules versus standard tablets. A study involving 24 normal human subjects found that the sustained-action capsule and the reference standard tablets were bioequivalent in terms of plasma concentration profiles and urinary excretion. This indicates that the sustained-action formulation can provide consistent therapeutic levels of both drugs over an extended period[5].

Market Analysis

Market Size and Growth

The chlorpheniramine maleate market was valued at $468.6 million in 2022 and is projected to reach $751.4 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 4.9% from 2023 to 2032. This growth is driven by the increasing prevalence of allergic conditions such as hay fever, allergic rhinitis, and urticaria, as well as advancements in healthcare infrastructure and easy access to over-the-counter (OTC) medications[2].

Regional Market Dynamics

North America currently dominates the chlorpheniramine maleate market due to advanced healthcare infrastructure and high prevalence of allergic conditions. However, the Asia-Pacific region is expected to witness the highest growth rate during the forecast period, driven by rising awareness about allergies, an increase in the geriatric population, and growing air pollution in countries like India, China, Japan, and South Korea[2].

Competitive Landscape

The market is competitive, with key players such as Capellon Pharmaceuticals, Sun Pharmaceutical Industries Limited, Bayer AG, Viatris Inc., Johnson & Johnson, GlaxoSmithKline plc, Merck & Co., Inc., Novalab Healthcare Pvt. Ltd., Alkem Laboratories Ltd., and Zydus Lifesciences Limited. These companies are involved in research and development activities to create novel therapies with fewer side effects and greater efficacy, which is expected to drive market growth[2].

Market Projections

Future Growth Drivers

Several factors are expected to drive the growth of the chlorpheniramine maleate market:

• Increasing Prevalence of Allergic Conditions: The rise in allergic disorders such as hay fever, allergic rhinitis, and urticaria will continue to drive demand for antihistamines like chlorpheniramine maleate.
• Advancements in Healthcare: Improvements in healthcare infrastructure and easy access to OTC medications will contribute to market growth.
• R&D Activities: Ongoing research and development aimed at creating more effective and safer antihistamines will provide lucrative opportunities for market expansion[2].

Challenges and Restraints

Despite the positive outlook, there are several challenges that could impact market growth:

• Side Effects: Potential side effects of chlorpheniramine maleate, such as drowsiness, dry mouth, blurred vision, and urinary retention, may deter some consumers.
• Shift to Alternative Medicines: Changes in consumer preferences towards natural remedies and holistic approaches could reduce demand for conventional antihistamines[2].

Therapeutic Uses and Mechanism

Chlorpheniramine Maleate

Chlorpheniramine maleate is an antihistamine that binds to the histamine H1 receptor, blocking the action of endogenous histamine. This leads to temporary relief from symptoms such as red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies and the common cold[2].

Pseudoephedrine Hydrochloride

Pseudoephedrine hydrochloride acts as an α-adrenergic receptor agonist, stimulating α-adrenergic receptors in the smooth muscle of the blood vessels in the nasal passages. This causes constriction of the blood vessels, reducing nasal congestion and improving airflow through the nasal passages. It is primarily used as a decongestant for conditions like the common cold, allergies, or sinusitis[4].

Combination Therapy

Hydrocodone, Chlorpheniramine, and Pseudoephedrine

In some formulations, chlorpheniramine maleate and pseudoephedrine hydrochloride are combined with hydrocodone, an opioid agonist, to provide temporary relief of cough and upper respiratory symptoms associated with allergies or the common cold in adults. This combination is indicated for patients 18 years of age and older, with strict dosing guidelines due to the risks associated with opioid use[1].

Key Takeaways

• The chlorpheniramine maleate market is expected to grow significantly, driven by increasing prevalence of allergic conditions and advancements in healthcare.
• Clinical trials are ongoing to assess the efficacy and safety of chlorpheniramine maleate and pseudoephedrine hydrochloride in various patient populations.
• The Asia-Pacific region is anticipated to witness the highest growth rate due to rising awareness and increasing geriatric population.
• Despite growth drivers, the market faces challenges such as potential side effects and shifts towards alternative medicines.

FAQs

What is the primary use of chlorpheniramine maleate?

Chlorpheniramine maleate is primarily used to treat allergic conditions such as allergic rhinitis (hay fever), relieving symptoms like red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies and the common cold[2].

How does pseudoephedrine hydrochloride work?

Pseudoephedrine hydrochloride works by stimulating α-adrenergic receptors in the nasal passages, causing constriction of blood vessels and reducing nasal congestion[4].

What are the potential side effects of chlorpheniramine maleate?

Potential side effects include drowsiness, dry mouth, blurred vision, and urinary retention[2].

Why is the chlorpheniramine maleate market growing?

The market is growing due to the increasing prevalence of allergic conditions, advancements in healthcare infrastructure, and ongoing R&D activities to develop more effective and safer antihistamines[2].

What regions are expected to drive the growth of the chlorpheniramine maleate market?

North America currently dominates the market, but the Asia-Pacific region is expected to witness the highest growth rate during the forecast period due to rising awareness and an increasing geriatric population[2].

Sources

1. Drugs.com: Hydrocodone, Chlorpheniramine and Pseudoephedrine - Drugs.com
2. Allied Market Research: Chlorpheniramine Maleate Market Statistics and Forecast - 2032
3. FDA: 022113Orig1s000 - accessdata.fda.gov
4. Patsnap: Pseudoephedrine Hydrochloride - Drug Targets, Indications, Patents
5. PubMed: Evaluation of sustained-action chlorpheniramine-pseudoephedrine ...