CLINICAL TRIALS PROFILE FOR THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for Theophylline And Dextrose 5% In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000575 ↗	Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)	Completed	CAMP Steering Committee	Phase 3	1991-09-01	The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000575 ↗	Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1991-09-01	The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000575 ↗	Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3)	Completed	Johns Hopkins Bloomberg School of Public Health	Phase 3	1991-09-01	The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	Milton S. Hershey Medical Center	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00000578 ↗	NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1994-04-01	To conduct a collaborative program of research on asthma and pregnancy consisting of two studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate relationships between asthma severity and treatment programs and perinatal outcome, and the Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group of participating obstetric centers supported by the National Institute of Child Health and Human Development. Studies were co-funded by the NHLBI.

Clinical Trial Conditions for Theophylline And Dextrose 5% In Plastic Container

Condition Name

Condition Name for Theophylline And Dextrose 5% In Plastic Container
Intervention	Trials
Asthma	22
Chronic Obstructive Pulmonary Disease	9
COPD	8
Lung Diseases	6

Condition MeSH

Condition MeSH for Theophylline And Dextrose 5% In Plastic Container
Intervention	Trials
Asthma	20
Lung Diseases	18
Pulmonary Disease, Chronic Obstructive	18
Lung Diseases, Obstructive	14

Clinical Trial Locations for Theophylline And Dextrose 5% In Plastic Container

Trials by Country

Trials by Country for Theophylline And Dextrose 5% In Plastic Container
Location	Trials
United States	141
China	24
Japan	19
Canada	13
United Kingdom	12

Trials by US State

Trials by US State for Theophylline And Dextrose 5% In Plastic Container
Location	Trials
California	13
Colorado	11
Texas	10
Missouri	9
Tennessee	8

Clinical Trial Progress for Theophylline And Dextrose 5% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Theophylline And Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
Phase 4	20
Phase 3	19
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for Theophylline And Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
Completed	68
Unknown status	14
Recruiting	11

Clinical Trial Sponsors for Theophylline And Dextrose 5% In Plastic Container

Sponsor Name

Sponsor Name for Theophylline And Dextrose 5% In Plastic Container
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	10
Boehringer Ingelheim	4
Washington University School of Medicine	4

Sponsor Type

Sponsor Type for Theophylline And Dextrose 5% In Plastic Container
Sponsor	Trials
Other	126
Industry	31
NIH	13

Theophylline and Dextrose 5% in Plastic Container: Clinical Trials, Market Analysis, and Projections

Introduction

Theophylline, a methylxanthine derivative, is widely used for its diuretic, smooth muscle relaxant, bronchial dilation, and central nervous system stimulant properties. When combined with dextrose 5% in a plastic container, it forms a solution that is particularly useful in clinical settings for various therapeutic purposes. This article will delve into the clinical trials, market analysis, and future projections for this formulation.

Mechanism of Action

Theophylline acts as a phosphodiesterase inhibitor, adenosine receptor blocker, and histone deacetylase activator. These mechanisms contribute to its therapeutic effects, particularly in treating asthma, bronchospasm, and chronic obstructive pulmonary disease (COPD)[5].

Clinical Trials

Post-Dural Puncture Headache (PDPH) Treatment

Recent clinical trials have explored the efficacy of theophylline in treating post-dural puncture headache (PDPH), a common complication following spinal anesthesia. A study involving 60 patients divided into three groups showed that intravenous theophylline infusion significantly reduced headache severity compared to oral caffeine and analgesics or placebo. The visual pain scale (VPS) scores decreased significantly in the theophylline group, indicating its effectiveness in managing PDPH[4].

Meta-Analysis and Systematic Reviews

A meta-analysis of 15 studies evaluated the therapeutic and prophylactic effects of aminophylline and theophylline on PDPH. The results indicated a significant reduction in pain scores following theophylline treatment, with a standardized mean difference (SMD) of –1.67 (95% CI: –2.29 to –1.05). This suggests that theophylline is an effective treatment option for PDPH[1].

Market Analysis

Current Market Trends

The market for theophylline and dextrose 5% solutions is driven by the increasing demand for effective treatments for respiratory conditions and post-surgical complications. The convenience of administering theophylline in a dextrose solution, particularly in a plastic container, enhances its appeal in clinical settings.

Competitive Landscape

The market is competitive, with several brands offering theophylline formulations. However, the combination of theophylline with dextrose 5% in a plastic container offers a unique advantage due to its ease of administration and stability. Brands like Uniphyl and Theochron are well-established, but generic versions are also gaining traction due to cost-effectiveness[5].

Regulatory Environment

Regulatory bodies such as the FDA and EMA have approved theophylline for various indications, including asthma and COPD. The formulation with dextrose 5% must comply with strict quality and safety standards, which can impact market entry and competition.

Market Projections

Growth Potential

The global market for respiratory drugs is expected to grow significantly due to increasing prevalence of respiratory diseases and advancements in healthcare infrastructure. Theophylline and dextrose 5% solutions are likely to benefit from this trend, especially in regions with high incidence rates of asthma and COPD.

Emerging Markets

Emerging markets, particularly in Asia and Latin America, offer substantial growth opportunities. These regions have large populations with limited access to advanced healthcare, making affordable and effective treatments like theophylline and dextrose 5% solutions highly attractive.

Clinical Use and Administration

Indications

Theophylline in dextrose 5% is indicated for the treatment of chronic asthma, bronchospasm, and other chronic lung diseases. It is also used off-label for managing PDPH, as supported by recent clinical trials[4].

Administration

The solution is typically administered intravenously, which allows for rapid onset of action. The combination with dextrose 5% helps in maintaining hydration and provides a stable vehicle for theophylline, enhancing its therapeutic efficacy[2].

Safety and Side Effects

Common Side Effects

Common side effects of theophylline include nausea, vomiting, headache, and palpitations. However, when administered in a dextrose solution, these side effects can be mitigated to some extent due to the stabilizing effect of dextrose[3].

Serious Adverse Reactions

Serious adverse reactions are rare but can include seizures, heart arrhythmias, and severe allergic reactions. Monitoring patients closely during administration is crucial to manage these risks effectively.

Conclusion

Theophylline and dextrose 5% in a plastic container is a valuable therapeutic option, particularly for managing respiratory conditions and post-surgical complications like PDPH. The clinical trials have shown promising results, and the market analysis indicates strong growth potential. As healthcare continues to evolve, this formulation is likely to remain a significant player in the pharmaceutical market.

Key Takeaways

• Clinical Efficacy: Theophylline in dextrose 5% is effective in treating PDPH and respiratory conditions.
• Market Trends: Increasing demand for respiratory treatments and post-surgical care drives market growth.
• Regulatory Compliance: Strict quality and safety standards must be met for market approval.
• Emerging Markets: Significant growth opportunities exist in Asia and Latin America.
• Administration: Intravenous administration allows for rapid onset of action and is enhanced by the dextrose solution.

FAQs

Q: What are the primary indications for theophylline and dextrose 5%?

A: The primary indications include the treatment of chronic asthma, bronchospasm, and other chronic lung diseases. It is also used off-label for managing PDPH.

Q: How is theophylline and dextrose 5% solution administered?

A: The solution is typically administered intravenously, allowing for rapid onset of action.

Q: What are the common side effects of theophylline in dextrose 5%?

A: Common side effects include nausea, vomiting, headache, and palpitations.

Q: What are the serious adverse reactions associated with theophylline?

A: Serious adverse reactions can include seizures, heart arrhythmias, and severe allergic reactions.

Q: What is the market outlook for theophylline and dextrose 5% solutions?

A: The market is expected to grow significantly due to increasing demand for respiratory treatments and post-surgical care, particularly in emerging markets.

Sources

1. Post-dural puncture headache prevention and treatment with aminophylline and theophylline: A systematic review and meta-analysis. Anesth Pain Med, Vol. 18 No. 2.
2. Dextrose, unspecified form - Search Results | DrugBank Online. DrugBank.
3. Product Monograph: Levofloxacin in 5% Dextrose Injection. Health Canada.
4. The Efficiency of Intravenous Theophylline on the Headache Which Occurs After Spinal Anesthesia. Neurores.
5. TEP Ligand Summary Page - RCSB PDB. RCSB PDB.