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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR AMINOPHYLLINE


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All Clinical Trials for Aminophylline

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00130598 ↗ PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION Completed Swiss National Science Foundation Phase 2/Phase 3 2005-06-01 Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.
NCT00130598 ↗ PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION Completed University Hospital, Basel, Switzerland Phase 2/Phase 3 2005-06-01 Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.
NCT00312273 ↗ Aminophylline in Bradyasystolic Cardiac Arrest Completed Heart and Stroke Foundation of Canada Phase 2 2001-01-01 The purpose of this study is to evaluate the effect of aminophylline in patients with out-of-hospital bradyasystolic cardiac arrest.
NCT00312273 ↗ Aminophylline in Bradyasystolic Cardiac Arrest Completed Vancouver Coastal Health Research Institute Phase 2 2001-01-01 The purpose of this study is to evaluate the effect of aminophylline in patients with out-of-hospital bradyasystolic cardiac arrest.
NCT00312273 ↗ Aminophylline in Bradyasystolic Cardiac Arrest Completed Vancouver General Hospital Phase 2 2001-01-01 The purpose of this study is to evaluate the effect of aminophylline in patients with out-of-hospital bradyasystolic cardiac arrest.
NCT00442338 ↗ Study of MK-0476 in Adult Patients With Acute Asthma (0476-334) Completed Merck Sharp & Dohme Corp. Phase 3 2007-03-01 The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Aminophylline

Condition Name

Condition Name for Aminophylline
Intervention Trials
Acute Kidney Injury 5
Aminophylline 3
Chronic Obstructive Pulmonary Disease 2
Post-Dural Puncture Headache 2
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Condition MeSH

Condition MeSH for Aminophylline
Intervention Trials
Acute Kidney Injury 6
Wounds and Injuries 4
Post-Dural Puncture Headache 3
Headache 3
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Clinical Trial Locations for Aminophylline

Trials by Country

Trials by Country for Aminophylline
Location Trials
United States 13
Egypt 7
China 7
United Kingdom 2
Italy 2
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Trials by US State

Trials by US State for Aminophylline
Location Trials
Illinois 3
Colorado 2
North Carolina 2
California 2
Oklahoma 1
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Clinical Trial Progress for Aminophylline

Clinical Trial Phase

Clinical Trial Phase for Aminophylline
Clinical Trial Phase Trials
Phase 4 12
Phase 3 3
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Aminophylline
Clinical Trial Phase Trials
Completed 19
Not yet recruiting 9
Unknown status 4
[disabled in preview] 6
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Clinical Trial Sponsors for Aminophylline

Sponsor Name

Sponsor Name for Aminophylline
Sponsor Trials
Tanta University 3
Rush University Medical Center 3
Defense Advanced Research Projects Agency 2
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Sponsor Type

Sponsor Type for Aminophylline
Sponsor Trials
Other 47
U.S. Fed 3
Industry 1
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Aminophylline: Clinical Trials, Market Analysis, and Projections

Introduction

Aminophylline, a derivative of theophylline, is a medication widely used in the treatment of respiratory disorders such as asthma and Chronic Obstructive Pulmonary Disease (COPD). This article delves into recent clinical trials, market analysis, and future projections for aminophylline.

Clinical Trials and Efficacy

Renal Dysfunction in Neonates

A significant clinical trial conducted in Tehran, Iran, from June 2016 to May 2017, investigated the effect of aminophylline on preventing renal dysfunction in neonates with prenatal asphyxia. The study found that neonates who received aminophylline showed a significant improvement in renal function indices, including glomerular filtration rate (GFR) and urine output, compared to the placebo group[1].

Critically Ill Children

A prospective, open-label study at Penn State Hershey Children’s Hospital assessed the effects of aminophylline on urine output and inflammation in critically ill children. The results indicated a significant increase in urine output and a decrease in inflammatory cytokine concentrations, suggesting that aminophylline has diuretic and anti-inflammatory properties in addition to its bronchodilatory effects[4].

Market Analysis

Global Market Size and Growth

The global aminophylline market is projected to grow at a moderate pace. According to market reports, the market size is expected to reach $400 million by 2030, growing at a compound annual growth rate (CAGR) of 2.3% to 4% from 2024 to 2030[2][3][5].

Market Segmentation

The aminophylline market is segmented based on application, with the COPD segment holding the largest market share. This dominance is due to the rising global incidence of respiratory disorders, particularly COPD, which affects approximately 12% of the general population and is the third leading cause of mortality worldwide[2][5].

Regional Market Share

North America currently holds the largest market share due to its well-established healthcare infrastructure, advanced medical research facilities, and a higher prevalence of respiratory disorders. However, the Asia Pacific region is expected to grow at the highest CAGR over the forecast period[2][5].

Market Trends

Increasing Prevalence of Respiratory Disorders

The growing number of respiratory disorders and infections worldwide is a key driver of the aminophylline market. COPD, in particular, is a significant factor, as it causes breathing difficulties by restricting airflow and is most common among smokers and people over 40[2][5].

Patient Preference for Oral Medications

The rising preference for oral medications among patients is another factor fueling the market growth. Aminophylline, available in oral and intravenous forms, benefits from this trend as it offers a convenient treatment option for patients[2].

Technological Advancements and Healthcare Infrastructure

Advancements in personalized medicine and the development of patient-centric therapies, particularly in North America, contribute to the increasing demand for aminophylline. The region's well-established healthcare infrastructure also supports the rapid adoption of innovative treatments[2][5].

Key Players

The aminophylline market is moderately competitive, with several international and local players. Major companies operating in this market include Pfizer Inc., Omega Laboratories, Merck KGaA, Torque Pharma, Endo International, and ACTIZA PHARMACEUTICAL[5].

Future Projections

Market Growth

The market is expected to continue growing, driven by the increasing incidence of respiratory diseases and the need for cost-effective treatment options. The CAGR of 2% to 4% indicates a steady growth trajectory over the forecast period[2][3][5].

Regional Expansion

While North America is currently the largest market, the Asia Pacific region is anticipated to grow at the highest CAGR. This growth is attributed to the rising awareness about available treatment options and the increasing prevalence of respiratory disorders in this region[5].

Conclusion

Aminophylline remains a vital medication in the management of respiratory disorders, supported by clinical trials that highlight its efficacy in preventing renal dysfunction and improving respiratory and renal functions. The market analysis indicates a steady growth trajectory driven by the increasing prevalence of COPD and other respiratory diseases, patient preference for oral medications, and advancements in healthcare infrastructure.

Key Takeaways

  • Clinical Efficacy: Aminophylline is effective in preventing renal dysfunction in neonates with asphyxia and improves urine output and reduces inflammation in critically ill children.
  • Market Growth: The global aminophylline market is expected to grow at a CAGR of 2.3% to 4% from 2024 to 2030.
  • Market Segmentation: The COPD segment holds the largest market share, driven by the rising incidence of respiratory disorders.
  • Regional Dominance: North America currently holds the largest market share, but the Asia Pacific region is expected to grow at the highest CAGR.
  • Key Players: Major companies include Pfizer Inc., Omega Laboratories, Merck KGaA, and others.

FAQs

What is the current market size of the aminophylline market?

The aminophylline market was valued at $280 million in 2022 and is projected to reach $400 million by 2030[3].

Which segment holds the largest market share in the aminophylline market?

The COPD segment holds the largest market share due to the rising global incidence of respiratory disorders[2][5].

Which region is expected to grow at the highest CAGR in the aminophylline market?

The Asia Pacific region is expected to grow at the highest CAGR over the forecast period[5].

What are the primary drivers of the aminophylline market growth?

The primary drivers include the increasing prevalence of respiratory disorders, patient preference for oral medications, and advancements in healthcare infrastructure[2][5].

Who are the key players in the aminophylline market?

Key players include Pfizer Inc., Omega Laboratories, Merck KGaA, Torque Pharma, Endo International, and ACTIZA PHARMACEUTICAL[5].

Sources

  1. Journal of Advanced Medical and Dental Sciences: "Effect of Aminophylline in Preventing Renal Dysfunction among Neonates with Asphyxia"[1].
  2. Grand View Research: "Aminophylline Market Size, Share And Growth Report, 2030"[2].
  3. IndustryARC: "Aminophylline Market Size Report 2023 - 2030"[3].
  4. Frontiers in Pediatrics: "A prospective assessment of the effect of aminophylline therapy on urine output and inflammation in critically ill children"[4].
  5. Mordor Intelligence: "Aminophylline market Market Size & Share Analysis - Growth Trends"[5].

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