CLINICAL TRIALS PROFILE FOR THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for Theophylline 0.4% 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NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to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NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	Milton S. Hershey Medical Center	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current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 0.4% And Dextrose 5% In Plastic Container

Condition Name

Condition Name for Theophylline 0.4% 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 0.4% 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 0.4% And Dextrose 5% In Plastic Container

Trials by Country

Trials by Country for Theophylline 0.4% 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 0.4% And Dextrose 5% In Plastic Container
Location	Trials
California	13
Colorado	11
Texas	10
Missouri	9
Tennessee	8

Clinical Trial Progress for Theophylline 0.4% And Dextrose 5% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Theophylline 0.4% 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 0.4% And Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
Completed	68
Unknown status	14
Recruiting	11

Clinical Trial Sponsors for Theophylline 0.4% And Dextrose 5% In Plastic Container

Sponsor Name

Sponsor Name for Theophylline 0.4% 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 0.4% And Dextrose 5% In Plastic Container
Sponsor	Trials
Other	126
Industry	31
NIH	13

Theophylline 0.4% and Dextrose 5% in Plastic Container: Clinical Trials, Market Analysis, and Projections

Introduction

Theophylline, a methylxanthine derivative, is widely used in the management of symptoms associated with asthma, chronic obstructive pulmonary disease (COPD), and other chronic lung conditions. The formulation of Theophylline 0.4% in 5% Dextrose Injection USP, administered intravenously, is a critical component in the treatment of acute exacerbations of these conditions. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Mechanism of Action

Theophylline exhibits two primary actions in the airways: smooth muscle relaxation (bronchodilation) and suppression of airway responses to stimuli (non-bronchodilator prophylactic effects). These actions are mediated through the inhibition of phosphodiesterase isozymes (PDE III and PDE IV) and other molecular mechanisms that do not involve adenosine receptor antagonism[1][3][4].

Clinical Studies

Clinical trials have shown that theophylline significantly reduces dyspnea, air trapping, and the work of breathing in patients with COPD. It also improves the contractility of diaphragmatic muscles, although with little or no improvement in pulmonary function measurements[1][2][4].

Serum Concentration-Effect Relationship

Bronchodilation occurs within a serum theophylline concentration range of 5–20 mcg/mL, with clinically important improvements requiring concentrations greater than 10 mcg/mL. Maintaining concentrations between 10 and 15 mcg/mL optimizes therapeutic benefits while minimizing adverse reactions[1][2][4].

Market Analysis

Current Market

Theophylline in 5% Dextrose Injection USP is indicated as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for treating acute exacerbations of asthma and other chronic lung diseases. The market for this drug is substantial, given the prevalence of respiratory conditions such as asthma and COPD, which affect millions worldwide.

Market Trends

The global respiratory drugs market is growing due to increasing incidence of respiratory diseases, aging populations, and advancements in healthcare infrastructure. Theophylline, being a well-established and effective treatment, continues to hold a significant share in this market. However, competition from newer bronchodilators and combination therapies may impact its market position[3].

Pricing and Accessibility

The cost of Theophylline in 5% Dextrose Injection USP can vary based on region, healthcare system, and availability. Generally, it is considered a cost-effective option compared to some newer respiratory medications. However, accessibility can be limited in certain regions due to economic constraints and healthcare infrastructure[2].

Market Projections

Future Demand

The demand for Theophylline in 5% Dextrose Injection USP is expected to remain stable or increase slightly due to the ongoing prevalence of respiratory diseases. The World Health Organization (WHO) estimates that COPD will become the third leading cause of death worldwide by 2030, driving the need for effective treatments like theophylline[3].

Competitive Landscape

While theophylline faces competition from newer drugs, its established efficacy, safety profile, and cost-effectiveness ensure it remains a viable option. Pharmaceutical companies are also exploring combination therapies that include theophylline, which could further enhance its market position.

Regulatory Environment

Regulatory bodies continue to monitor the safety and efficacy of theophylline. Recent updates in prescribing information and warnings, such as the need for careful dose adjustment in elderly patients and those with reduced protein binding, highlight the ongoing regulatory scrutiny[1][2][4].

Patient and Healthcare Provider Perspectives

Patient Compliance

Patient compliance with theophylline therapy can be challenging due to the need for frequent monitoring of serum concentrations and potential side effects. However, the drug's effectiveness in managing symptoms makes it a valuable treatment option for many patients.

Healthcare Provider Insights

Healthcare providers appreciate theophylline's broad therapeutic window and its role as an adjunct therapy. However, they must be cautious about dose adjustments, especially in patients with altered pharmacokinetics, such as the elderly or those with hepatic cirrhosis[1][2][4].

Key Takeaways

• Efficacy: Theophylline in 5% Dextrose Injection USP is effective in managing symptoms of asthma and COPD through bronchodilation and non-bronchodilator prophylactic effects.
• Market Position: The drug holds a significant share in the respiratory drugs market due to its established efficacy and cost-effectiveness.
• Future Projections: Demand is expected to remain stable or increase slightly due to the prevalence of respiratory diseases.
• Regulatory Environment: Ongoing regulatory scrutiny emphasizes the importance of careful dose adjustment and monitoring.
• Patient and Provider Perspectives: Patient compliance and healthcare provider insights highlight the drug's value but also the need for careful management.

FAQs

Q: What are the primary indications for Theophylline in 5% Dextrose Injection USP?

A: The primary indications are for the treatment of acute exacerbations of symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, such as emphysema and chronic bronchitis[2][4].

Q: What is the optimal serum concentration range for theophylline?

A: The optimal serum concentration range for theophylline is between 10 and 15 mcg/mL, which balances therapeutic benefits and minimizes adverse reactions[1][2][4].

Q: How is theophylline metabolized in the body?

A: Theophylline is primarily metabolized in the liver through demethylation and hydroxylation pathways, with approximately 90% of the dose metabolized in adults and pediatric patients beyond one year of age[2][3][4].

Q: Are there any specific precautions for administering theophylline to elderly patients?

A: Yes, elderly patients require careful dose reduction and frequent monitoring of serum theophylline concentrations due to decreased clearance and potential toxicity[1][2][4].

Q: Can theophylline be used in patients with known allergies to corn or corn products?

A: No, solutions containing dextrose may be contraindicated in patients with known allergies to corn or corn products[2][4].

Sources

1. Theophylline in 5% Dextrose Injection USP - DailyMed.
2. Theophylline in Dextrose: Package Insert / Prescribing Info - Drugs.com.
3. Theophylline: Uses, Interactions, Mechanism of Action - DrugBank.
4. Theophylline Injection, Solution - FDA.
5. Bronchodilation from intravenous theophylline in patients with cystic fibrosis - PubMed.