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Last Updated: April 12, 2025

CLINICAL TRIALS PROFILE FOR BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE


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All Clinical Trials for brompheniramine maleate; pseudoephedrine hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01177852 ↗ Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis Withdrawn Ache Laboratorios Farmaceuticos S.A. Phase 3 2011-10-01 Multicenter clinical trial, phase III, controlled by active medicine, open, randomized, enroll 962 children, 2 to 12 years old, that suffer acute inflammation upper airway characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and no more than 5 consecutive days (without systemic/topic use of medication during this period) followed by nasal congestion, with or without associate other nasal symptoms (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 1 of 1 entries

Clinical Trial Conditions for brompheniramine maleate; pseudoephedrine hydrochloride

Condition Name

1110-0.100.10.20.30.40.50.60.70.80.911.1InflammationRhinitisCough[disabled in preview]
Condition Name for brompheniramine maleate; pseudoephedrine hydrochloride
Intervention Trials
Inflammation 1
Rhinitis 1
Cough 1
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Condition MeSH

11110-0.100.10.20.30.40.50.60.70.80.911.1CoughCommon ColdRhinitisInflammation[disabled in preview]
Condition MeSH for brompheniramine maleate; pseudoephedrine hydrochloride
Intervention Trials
Cough 1
Common Cold 1
Rhinitis 1
Inflammation 1
[disabled in preview] 0
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Clinical Trial Progress for brompheniramine maleate; pseudoephedrine hydrochloride

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 3[disabled in preview]
Clinical Trial Phase for brompheniramine maleate; pseudoephedrine hydrochloride
Clinical Trial Phase Trials
Phase 3 1
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Withdrawn[disabled in preview]
Clinical Trial Status for brompheniramine maleate; pseudoephedrine hydrochloride
Clinical Trial Phase Trials
Withdrawn 1
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Clinical Trial Sponsors for brompheniramine maleate; pseudoephedrine hydrochloride

Sponsor Name

trials000001111111Ache Laboratorios Farmaceuticos S.A.[disabled in preview]
Sponsor Name for brompheniramine maleate; pseudoephedrine hydrochloride
Sponsor Trials
Ache Laboratorios Farmaceuticos S.A. 1
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Sponsor Type

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Industry[disabled in preview]
Sponsor Type for brompheniramine maleate; pseudoephedrine hydrochloride
Sponsor Trials
Industry 1
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Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide: Clinical Trials, Market Analysis, and Projections

Introduction

Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide are components of a commonly used medication for relieving symptoms associated with allergies and the common cold. This article will delve into the clinical aspects, market analysis, and future projections of this drug combination.

Clinical Use and Mechanism of Action

Brompheniramine Maleate

Brompheniramine maleate is an antihistamine that belongs to the alkylamine class. It acts as an H1-receptor-blocking agent, competing with histamine for receptor sites on effector cells. This action helps in alleviating allergic responses such as vasodilation, increased vascular permeability, and increased mucus secretion in nasal tissue[1][4].

Pseudoephedrine Hydrochloride

Pseudoephedrine hydrochloride is a sympathomimetic decongestant that reduces nasal and sinus congestion by constricting blood vessels in the nasal passages. It is available in various forms, including tablets, extended-release tablets, capsules, and suspensions[2].

Dextromethorphan Hydrobromide

Dextromethorphan hydrobromide is a cough suppressant that acts on the brain to reduce the urge to cough. It is often combined with other medications to treat coughs and upper respiratory symptoms associated with allergies and the common cold[1][4].

Clinical Trials and Safety

Animal Studies

There have been no comprehensive animal studies conducted to assess the carcinogenic, mutagenic, or fertility-impacting potential of the combination of brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide. However, studies on brompheniramine maleate in rats and mice at doses up to 16 times the maximum human dose have shown no evidence of impaired fertility or harm to the fetus[1].

Human Studies

Clinical studies on this combination have not included sufficient numbers of subjects aged 65 and over to determine whether elderly patients respond differently. However, it is known that antihistamines and sympathomimetics can cause more adverse reactions in elderly patients, such as dizziness, sedation, and hypotension[1].

Adverse Reactions

Common adverse reactions include sedation, dryness of mouth, nose, and throat, thickening of bronchial secretions, and dizziness. Other reactions may include dermatologic issues like urticaria and drug rash, cardiovascular effects such as hypotension and hypertension, and central nervous system effects like disturbed coordination and visual disturbances[1].

Market Analysis

Current Market Size

The global market for brompheniramine, a key component of this drug combination, was valued at USD 10 billion in 2023. This market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4% from 2024 to 2031, reaching USD 14 billion by 2031[3].

Driving Factors

Several factors are driving the growth of the brompheniramine market:

  • Increasing Prevalence of Allergies: Environmental issues like pollution and climate change are contributing to a global increase in allergy cases, driving up demand for antihistamines like brompheniramine.
  • Accessibility and Awareness: The wide availability of over-the-counter (OTC) formulations and growing consumer knowledge of allergy management are significant contributors.
  • Healthcare Infrastructure: Expanding healthcare infrastructure and rising disposable incomes in emerging nations are also driving the demand for allergy treatments[3].

Market Projections

Future Growth

The market for brompheniramine and its combinations is expected to continue growing due to the increasing incidence of seasonal allergies, particularly in urban areas. The proliferation of OTC formulations and the growing awareness of allergy management alternatives will further propel this growth[3].

Emerging Trends

  • Sugar-Free and Ready-to-Use Formulations: The development of sugar-free, ready-to-use liquid concentrates that are stable and have an acceptable taste is expected to improve patient compliance, especially among pediatric, geriatric, and health-conscious patients[2].
  • Improved Formulations: Innovations in pharmaceutical formulations, such as spill-resistant and accurately dosable liquids, will provide better options for patients who have difficulty swallowing tablets or capsules[2].

Key Takeaways

  • Clinical Use: Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide are used to relieve symptoms of allergies and the common cold.
  • Safety: The combination should be used with caution in patients with certain medical conditions and in elderly patients due to potential adverse reactions.
  • Market Size: The global market for brompheniramine was valued at USD 10 billion in 2023 and is projected to reach USD 14 billion by 2031.
  • Growth Drivers: Increasing allergy prevalence, accessibility of OTC formulations, and growing consumer awareness are key drivers of market growth.
  • Future Trends: Innovations in sugar-free, ready-to-use formulations and improved patient compliance are expected to shape the market.

FAQs

What are the primary components of Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide?

The primary components are brompheniramine maleate (an antihistamine), pseudoephedrine hydrochloride (a decongestant), and dextromethorphan hydrobromide (a cough suppressant).

What are the common adverse reactions to this drug combination?

Common adverse reactions include sedation, dryness of mouth, nose, and throat, thickening of bronchial secretions, and dizziness. Other reactions may include dermatologic, cardiovascular, and central nervous system effects.

Why is the market for brompheniramine growing?

The market is growing due to the increasing prevalence of allergies, the accessibility of OTC formulations, growing consumer awareness of allergy management, and the expansion of healthcare infrastructure in emerging nations.

What are the innovations in the formulation of this drug combination?

Recent innovations include the development of sugar-free, ready-to-use liquid concentrates that are stable and have an acceptable taste, and spill-resistant formulations that are more accurately dosable.

Who should use this drug combination with caution?

Patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, urinary bladder neck obstruction, diabetes, hypertension, heart disease, or thyroid disease should use this combination with caution.

Are there any specific precautions for elderly patients?

Yes, elderly patients are more likely to experience adverse reactions such as dizziness, sedation, and hypotension. Dose selection should be cautious, usually starting at the low end of the dosing range.

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