CLINICAL TRIALS PROFILE FOR DOXAPRAM HYDROCHLORIDE

All Clinical Trials for DOXAPRAM HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02171910 ↗	Doxapram as an Additive to Propofol Sedation in Sedation for ERCP	Completed	Helsinki University Central Hospital	Phase 4	2016-10-01	Sedation is needed in order to complete endoscopic retrograde cholangiopancreatography (ERCP) to alleviate discomfort and pain during the procedure. This is usually achieved with use of opioids and/or sedative agents such as benzodiazepines or propofol. Traditionally benzodiazepines have been used but nowadays propofol is becoming the drug of choice for sedation during ERCP. The problem with propofol sedation is the fact that it may case cardiorespiratory depression and there is no antidote for this like there is for benzodiazepines. Cardiovascular depression can usually be easily counteracted with drugs that are used to raise blood pressure or heart rate during general anesthesia but respiratory depression remains a problem. The aim of this study is to try to counteract the respiratory depression caused by propofol sedation using an old respiratory stimulant doxapram as opposed to placebo using a double blind randomized protocol. The investigators hypothesis is that boluses and an infusion of doxapram will alleviate the respiratory depression caused by propofol sedation.
NCT02820025 ↗	The Effect and Mechanism of Respiratory Stimulant Doxapram on Facilitating Emergence	Unknown status	General Hospital of Ningxia Medical University	N/A	2015-10-01	The current study is designed to investigate the difference of plasma orexin A levels between doxapram group and controlled group at emergence time from sevoflurane-remifentanil anesthesia who will undergo elective lumbar surgery.
NCT01022151 ↗	Aminophylline and Cognitive Function After Sevoflurane Anaesthesia	Completed	King Faisal University	Phase 2	2007-11-01	Early postoperative recovery of neurologic and cognitive functions is especially advantageous after fast-tracking ambulatory procedures to hasten home discharge after surgery.1 It is well known that volatile anaesthetic agents may generate adverse postoperative cognitive effects and even traces of it may affect task performance in healthy volunteers.2Hence, rapid elimination of the volatile anaesthetics may help reduce postoperative confusion and cognitive impairment in surgical patients by facilitating a faster recovery from general anaesthesia.3 Sevoflurane has been advocated for the routine anesthesia for ambulatory surgery patients. It activates adenosine A1 receptors in primary rat hippocampal cultures through the liberation of adenosine secondary to the interaction of with adenosine transport or key enzymes in adenosine metabolism.4 However; sevoflurane anaesthesia is associated with slower emergence and delayed early postoperative cognitive recovery than desflurane5 and xenon2 anaesthesia. Aminophylline, which is a hydrophilic cyclic adenosine mono-phosphate (cAMP) dependent phosphodiesterase inhibitor has been used for long time to antagonize the sedative effects of morphine, diazepam, and barbiturates.6-7Aminophylline in doses of 2-5 mg/kg shortens the recovery from sevoflurane anaesthesia and improves bispectral index scores (BIS) with concurrent increases in heart rate which might have a detrimental effect in patients with ischaemic heart disease.8-11However, the use of smaller doses of 2-3 mg/kg is associated with less increases in heart rate. 10-11 The use of 1 mg/kg of Doxapram is comparable to 2 mg/kg of aminophylline in improvement of early recovery from sevoflurane anaesthesia secondary to its central nervous system stimulating effect rather than increased ventilatory elimination of sevoflurane.11 Currently, there is no available published studies have investigated the effects of either theophylline or doxapram on early postoperative cognitive recovery after balanced anaesthesia with sevoflurane. We hypothesized that the use of small doses of aminophylline [2-3 mg/kg] may be comparable to larger doses in improvement of the early postoperative cognitive recovery from sevoflurane anaesthesia with associated non-significant increases in heart rate. The present study investigated the effects of 1 mg/kg of doxapram, and 2, 3, 4, and 5 mg/kg of aminophylline on the early postoperative cognitive recovery using the Short Orientation Memory Concentration Test (SOMCT), response entropy (RE) state entropy (SE), difference between RE and SE (RE-SE), end-tidal sevoflurane concentration, haemodynamics, the times to eyes opening and to extubation and degree of sedation after sevoflurane anaesthesia in patients undergoing ambulatory surgery.
NCT00477451 ↗	Staccato Alprazolam in Panic Attack	Completed	Alexza Pharmaceuticals, Inc.	Phase 2	2007-05-01	We are developing Staccato™ Alprazolam for the treatment of Panic attacks associated with panic disorder. This study will provide an initial assessment of efficacy, and to continue to describe the tolerability and pharmacokinetics, of a single inhaled dose of Staccato Alprazolam on a doxapram-induced panic attack in patients with panic disorder.
NCT00389909 ↗	Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants	Completed	Jean Michel Hascoet	Phase 4	2006-11-01	Doxapram is used to stimulate respiration. For a given dose, the fluctuations in concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of this study is to compare a dosage regimen based only on patient's weight, to another one using a dosing chart taking into account weight, age and gender.
NCT00389909 ↗	Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants	Completed	Maternite Regionale Universitaire	Phase 4	2006-11-01	Doxapram is used to stimulate respiration. For a given dose, the fluctuations in concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of this study is to compare a dosage regimen based only on patient's weight, to another one using a dosing chart taking into account weight, age and gender.
NCT00088738 ↗	Evaluation of Substance P Neurotransmission in Panic Disorder by PET Imaging of NK1 Receptors With [18F]SPA-RQ	Completed	National Institute of Mental Health (NIMH)	Phase 1	2004-07-27	This study is designed to observe the effects of a panic attack in patients with panic disorders and to demonstrate the involvement of Substance P in panic disorder, and thereby, further our understanding of its role in this illness. We will measure levels of Substance P in the brain by obtaining pictures of the brain using PET and MRI....

Clinical Trial Conditions for DOXAPRAM HYDROCHLORIDE

Condition Name

Condition Name for DOXAPRAM HYDROCHLORIDE
Intervention	Trials
Postoperative Shivering	2
Treatment of Induced Panic Attack	1
Panic Attack	1
Weaning Failure	1

Condition MeSH

Condition MeSH for DOXAPRAM HYDROCHLORIDE
Intervention	Trials
Panic Disorder	2
Hypoxia	1
Premature Birth	1
Confusion	1

Clinical Trial Locations for DOXAPRAM HYDROCHLORIDE

Trials by Country

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Trials by Country for DOXAPRAM HYDROCHLORIDE
Location	Trials
Netherlands	7
Egypt	5
Belgium	5
United States	2
Pakistan	1

Trials by US State

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Trials by US State for DOXAPRAM HYDROCHLORIDE
Location	Trials
New York	1
Maryland	1

Clinical Trial Progress for DOXAPRAM HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for DOXAPRAM HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for DOXAPRAM HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	6
Unknown status	4
Recruiting	3

Clinical Trial Sponsors for DOXAPRAM HYDROCHLORIDE

Sponsor Name

Sponsor Name for DOXAPRAM HYDROCHLORIDE
Sponsor	Trials
Beni-Suef University	2
South Valley University	1
Helsinki University Central Hospital	1

Sponsor Type

Sponsor Type for DOXAPRAM HYDROCHLORIDE
Sponsor	Trials
Other	16
Industry	1
NIH	1

Doxapram Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Doxapram hydrochloride is a respiratory stimulant used primarily to treat acute respiratory insufficiency, particularly in patients with chronic obstructive pulmonary disease (COPD) and those experiencing post-anesthetic or drug-induced respiratory depression. Here, we will delve into the clinical trials, market analysis, and projections for this crucial medication.

Clinical Trials and Mechanism of Action

Mechanism of Action

Doxapram hydrochloride acts as an analeptic agent, stimulating the central nervous system and peripheral carotid chemoreceptors. This stimulation increases tidal volume and slightly elevates respiratory rate. The drug also triggers a pressor response, which is more pronounced in hypovolemic states due to improved cardiac output rather than peripheral vasoconstriction[1][4].

Clinical Trials

While specific recent clinical trial data for doxapram hydrochloride is limited, its efficacy has been well-established in treating acute respiratory insufficiency. Clinical trials have shown that doxapram hydrochloride is effective in managing respiratory depression in post-anesthetic and emergency care scenarios. The drug's ability to stimulate respiratory function without affecting the metabolism of CNS-depressant drugs makes it a valuable tool in critical care settings[1][4].

Market Analysis

Market Size and Growth

The doxapram hydrochloride injection market is experiencing significant growth, driven by increasing demand for respiratory stimulation in post-anesthesia and acute respiratory failure cases. The market is projected to grow from USD 4.35 billion in 2024 to USD 9.77 billion by 2031, reflecting a robust expansion in the coming years[2].

Key Drivers

Several factors are driving the growth of the doxapram hydrochloride market:

• Increasing Surgical Procedures: The rise in global surgical procedures has increased the demand for doxapram injections to manage post-surgical respiratory depression.
• Growing Prevalence of Respiratory Disorders: The increasing prevalence of respiratory disorders, coupled with an aging population prone to breathing difficulties, is fueling market growth.
• Expansion of Healthcare Services: The growth of healthcare services in emerging regions and the increasing number of intensive care units are bolstering market demand.
• Advancements in Drug Delivery Systems: Improvements in drug delivery systems and favorable healthcare policies are also contributing to the market's expansion[2].

Regional Market Dynamics

The doxapram hydrochloride market is geographically diverse, with key regions including:

• Asia-Pacific: This region is rapidly growing due to countries like China, Japan, India, and South Korea, driven by large populations, rising disposable incomes, and increasing urbanization.
• Europe: Characterized by a mature market with well-established infrastructure, Europe includes countries such as the UK, Germany, France, and Italy.
• Latin America: This region presents opportunities and challenges, with countries like Brazil, Mexico, and Argentina being key players, though economic fluctuations and political instability can impact market dynamics[2].

Market Projections

Future Growth

The market for doxapram hydrochloride is expected to continue its upward trend from 2023 to 2031. Key projections include:

• Market Size: The market is anticipated to reach USD 9.77 billion by 2031, up from USD 4.35 billion in 2024.
• Segmentation: The market is categorized based on type (5ml, 20ml) and application (hospital, clinic), with geographical regions also playing a significant role[2][5].

Strategic Consolidation

The market is witnessing a wave of mergers and acquisitions as companies seek to consolidate their market positions, expand their product portfolios, and leverage synergies to drive growth and competitiveness. Access to new technologies, intellectual property, and talent through acquisitions is enabling companies to innovate faster and stay ahead of market trends[2].

Challenges and Opportunities

Challenges

Despite the growth, the market faces several challenges:

• Regulatory Environment: Stringent regulations and the need for continuous compliance can impact market dynamics.
• Economic Fluctuations: Economic instability in certain regions can affect consumer behavior and market growth.
• Sustainability Concerns: Growing environmental concerns and the shift towards sustainable alternatives may influence market preferences[2].

Opportunities

The market also presents several opportunities:

• Increasing Urbanization: The rising urban population, especially in urban centers, is propelling the demand for doxapram hydrochloride injections.
• Advancements in Healthcare: Improvements in emergency medicine and the expansion of critical care facilities are driving the demand for respiratory stimulants.
• Favorable Healthcare Policies: Supportive healthcare policies in various regions are bolstering the market's expansion[2].

Key Takeaways

• Clinical Efficacy: Doxapram hydrochloride is clinically effective in treating acute respiratory insufficiency and post-anesthetic respiratory depression.
• Market Growth: The market is projected to grow significantly from USD 4.35 billion in 2024 to USD 9.77 billion by 2031.
• Key Drivers: Increasing surgical procedures, growing prevalence of respiratory disorders, and advancements in healthcare services are driving market growth.
• Regional Dynamics: Asia-Pacific, Europe, and Latin America are key regions with varying market dynamics.
• Strategic Consolidation: Mergers and acquisitions are shaping the market landscape.

FAQs

What is the primary use of doxapram hydrochloride?

Doxapram hydrochloride is primarily used as a temporary measure to treat acute respiratory insufficiency in hospitalized patients, especially those with chronic obstructive pulmonary disease (COPD) and those experiencing post-anesthetic or drug-induced respiratory depression[1][4].

What are the key drivers of the doxapram hydrochloride market?

Key drivers include the increasing number of surgical procedures, the growing prevalence of respiratory disorders, the expansion of healthcare services in emerging regions, and advancements in drug delivery systems[2].

What is the projected market size of doxapram hydrochloride by 2031?

The market is projected to reach USD 9.77 billion by 2031[2].

Which regions are driving the growth of the doxapram hydrochloride market?

The Asia-Pacific region, driven by countries like China, Japan, India, and South Korea, is a significant contributor to market growth. Europe and Latin America are also important regions[2].

What are the challenges facing the doxapram hydrochloride market?

Challenges include stringent regulations, economic fluctuations, and growing environmental concerns that may influence market preferences[2].

Sources

1. DOPRAM Injection - FDA Label. [Accessed 2023].
2. Doxapram Hydrochloride Injection Market Size, Share and Forecast - OpenPR. [Accessed 2023].
3. Antimicrobial Drugs Market Returns Analysis - ASPE. [Accessed 2023].
4. Doxapram: Uses, Interactions, Mechanism of Action - DrugBank Online. [Accessed 2023].
5. Doxapram Hydrochloride Market Size, Scope And Forecast Report - Market Research Intellect. [Accessed 2023].