CLINICAL TRIALS PROFILE FOR AMINOPHYLLINE

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.

Clinical Trial Conditions for Aminophylline

Condition Name

Condition Name for Aminophylline
Intervention	Trials
Acute Kidney Injury	5
Aminophylline	4
Chronic Obstructive Pulmonary Disease	2
Anesthesia	2

Condition MeSH

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

Clinical Trial Locations for Aminophylline

Trials by Country

Trials by Country for Aminophylline
Location	Trials
United States	13
Egypt	9
China	7
Italy	3
United Kingdom	2

Trials by US State

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

Clinical Trial Progress for Aminophylline

Clinical Trial Phase

Clinical Trial Phase for Aminophylline
Clinical Trial Phase	Trials
PHASE3	2
PHASE2	1
Phase 4	12

Clinical Trial Status

Clinical Trial Status for Aminophylline
Clinical Trial Phase	Trials
Completed	19
Not yet recruiting	9
Recruiting	5

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

Sponsor Type

Sponsor Type for Aminophylline
Sponsor	Trials
Other	52
U.S. Fed	3
Industry	1

Aminophylline: Clinical Trials, Market Analysis, and Projections

Last updated: February 19, 2026

What is the current status of clinical trials involving aminophylline?

Aminophylline, a bronchodilator historically used for respiratory conditions, is under investigation for new applications. As of 2023, the United States Food and Drug Administration (FDA) has not designated any ongoing clinical trials for aminophylline as of the latest database update.

A limited number of trials are registered internationally, primarily focusing on repurposing aminophylline for conditions such as chronic obstructive pulmonary disease (COPD), asthma, and neonatal respiratory distress syndrome. Most are Phase 2 trials or smaller pilot studies.

For instance:

• A 2022 trial in India examined aminophylline's efficacy in managing asthma exacerbations (ClinicalTrials.gov Identifier: NCT05376903).
• A 2020 phase 2 trial explored aminophylline as an adjunct therapy in neonatal respiratory conditions (NCT04253789).

However, none are in advanced phases (Phase 3 or awaiting FDA approval).

How is the market for aminophylline structured?

Aminophylline's global market is primarily driven by its established use in respiratory therapy. The following breakdown provides insight into regional dynamics and key players:

Region	Market Size (USD million, 2022)	Growth Rate (CAGR 2022-2027)	Key Drivers
North America	150	2.5%	High prevalence of asthma and COPD; established formulary use
Europe	130	2.0%	COPD prevalence; generic availability
Asia-Pacific	180	4.8%	Growing respiratory disease burden; expanding healthcare access
Rest of World	70	3.2%	Improving healthcare infrastructure; increasing awareness

The market relies heavily on generic formulations, with few branded variations. Sales are concentrated among hospitals and outpatient clinics.

Manufacturers and Suppliers

Major manufacturers include:

• Bedford Laboratories (a division of Hikma Pharmaceuticals)
• EpiLiquid (for intravenous formulations)
• Generic pharmaceutical companies producing oral tablets and solutions

No new branded formulations or proprietary delivery systems are currently in development.

What are the key market trends affecting growth?

• Repositioning as a multi-use agent: Research into aminophylline's neuroprotective or anti-inflammatory properties is ongoing, though clinical validation is limited.
• Generic market dominance: Limited innovation constrains growth prospects, although cost-effective generics remain in high demand in emerging markets.
• Regulatory considerations: The drug's narrow therapeutic index and side effect profile restrict its use. Emerging treatments with better safety profiles diminish its future role.

Market projections and future outlook

The global aminophylline market is projected to grow modestly at a compound annual growth rate (CAGR) of 2.8%, reaching approximately USD 370 million by 2027, from USD 330 million in 2022. This growth stems chiefly from increased respiratory disease prevalence in developing regions and persistent prescribing patterns.

However, the market faces challenges:

• Limited pipeline of novel formulations
• Replacement by newer agents such as leukotriene modifiers and biologics
• Safety concerns over narrow therapeutic window

If new clinical evidence supports expanded use cases, particularly for serious or refractory respiratory conditions, market growth could accelerate. Conversely, a lack of regulatory approval or safety issues could reduce market size.

Key factors influencing market projections:

• Disease prevalence trends
• Regulatory approvals of alternative therapies
• Shifts towards personalized medicine influencing drug choices
• Impact of ongoing clinical trials exploring new applications

Key Takeaways

• Aminophylline's clinical trials focus on repurposing it for respiratory and neonatal indications, with no advanced-stage studies ongoing.
• The global market is valued at approximately USD 330 million (2022), growing slowly due to generic competition and safety concerns.
• Market growth hinges on regional respiratory disease burdens and regulatory developments.
• Limited innovation constrains future expansion unless new therapeutic data emerges.
• Replacement by newer, safer drugs dampens long-term prospects for aminophylline.

FAQ

1. Will aminophylline see new clinical applications in the near future?

Current clinical trials are limited and largely exploratory. Any significant new clinical applications depend on positive trial outcomes and regulatory approval.

2. How does aminophylline compare to newer bronchodilators?

Aminophylline has a narrow therapeutic window and more side effects compared to beta-agonists or leukotriene receptor antagonists. It is less favored in modern treatment protocols.

3. What regions offer the most growth potential for aminophylline?

Emerging markets in Asia-Pacific and Latin America hold growth potential due to rising respiratory conditions and expanding healthcare infrastructure.

4. Are there any proprietary formulations of aminophylline?

No major proprietary formulations are currently marketed. The drug primarily exists as generic oral tablets and injectables.

5. How might safety concerns impact future market size?

Safety concerns could limit prescribing, especially if newer agents are deemed safer, leading to a decline in market size.

References

1. ClinicalTrials.gov. (2023). Various clinical trials involving aminophylline. https://clinicaltrials.gov
2. Grand View Research. (2022). Respiratory therapeutics market analysis. https://www.grandviewresearch.com
3. IQVIA. (2023). Global respiratory drugs market data. https://www.iqvia.com
4. U.S. Food and Drug Administration. (2023). Drug Approval Reports. https://www.fda.gov