CLINICAL TRIALS PROFILE FOR THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for Theophylline 0.16% 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NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to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NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	Milton S. Hershey Medical Center	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current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 0.16% And Dextrose 5% In Plastic Container

Condition Name

Condition Name for Theophylline 0.16% 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 0.16% 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 0.16% And Dextrose 5% In Plastic Container

Trials by Country

Trials by Country for Theophylline 0.16% 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 0.16% And Dextrose 5% In Plastic Container
Location	Trials
California	13
Colorado	11
Texas	10
Missouri	9
Tennessee	8

Clinical Trial Progress for Theophylline 0.16% And Dextrose 5% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Theophylline 0.16% 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 0.16% And Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
Completed	68
Unknown status	14
Recruiting	11

Clinical Trial Sponsors for Theophylline 0.16% And Dextrose 5% In Plastic Container

Sponsor Name

Sponsor Name for Theophylline 0.16% 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 0.16% And Dextrose 5% In Plastic Container
Sponsor	Trials
Other	126
Industry	31
NIH	13

Theophylline 0.16% and Dextrose 5% in Plastic Container: Clinical Trials, Market Analysis, and Projections

Introduction

Theophylline, a methylxanthine derivative, is widely used in the management of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). When administered in a 0.16% solution with 5% dextrose in a plastic container, it offers a convenient and effective treatment option for acute exacerbations of these conditions. Here, we will delve into the clinical trials, market analysis, and future projections for this formulation.

Clinical Trials and Efficacy

Mechanism of Action

Theophylline works through two primary mechanisms: smooth muscle relaxation (bronchodilation) and suppression of the airways' response to stimuli (non-bronchodilator prophylactic effects). It enhances calcium uptake through an adenosine-mediated channel, increasing the force of contraction of diaphragmatic muscles[1][3].

Clinical Studies

Clinical studies have shown that theophylline decreases 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. In acute asthma exacerbations, particularly in patients not responding to inhaled beta-2 selective agonists, intravenous theophylline has been beneficial[1][3].

Serum Concentration-Effect Relationship

The therapeutic range for serum theophylline concentrations is between 5-20 mcg/mL, with clinically important improvements typically requiring concentrations greater than 10 mcg/mL. Maintaining average serum concentrations between 10-15 mcg/mL is recommended to maximize therapeutic benefits while minimizing adverse effects[1][3].

Market Analysis

Global Market Size and Growth

The global theophylline market is projected to grow significantly. As of 2024, the market size is estimated at USD 451.5 million, with a compound annual growth rate (CAGR) of 6.50% expected from 2024 to 2031. This growth is driven by the increasing prevalence of respiratory diseases such as asthma and COPD[2].

Regional Market Share

North America holds the largest market share, accounting for over 40% of the global revenue with a market size of USD 180.60 million in 2024. Europe follows closely, with a market share of more than 30% and a market size of USD 135.45 million. The Asia Pacific region also shows significant growth, with a market share of around 23% and a CAGR of 8.5% from 2024 to 2031[2].

Market Segmentation

The market is segmented based on region, application, and distribution channels. The increasing demand for theophylline in treating chronic lung diseases, particularly in regions with high prevalence rates, drives market growth. Hospital settings and emergency departments are key consumers of intravenous theophylline formulations[2].

Market Projections

Future Growth Drivers

The surging prevalence of respiratory diseases, coupled with the aging population and increasing air pollution, is expected to drive the demand for theophylline. Advances in healthcare infrastructure and the availability of more convenient and effective formulations, such as the 0.16% theophylline and 5% dextrose solution, will further boost market growth[2].

Challenges and Opportunities

Despite the positive outlook, the market faces challenges such as the potential for adverse reactions at high serum concentrations and the need for careful dosage adjustments. However, these challenges also present opportunities for innovation in drug delivery systems and personalized medicine approaches to optimize theophylline therapy[1][3].

Pharmacokinetics and Dosage Adjustments

Metabolism and Elimination

Approximately 90% of the theophylline dose is metabolized in the liver, primarily through N-demethylation and hydroxylation pathways. The drug is excreted mainly as metabolites in the urine, with only a small fraction excreted unchanged. This metabolism can be influenced by various factors, including age, liver function, and concurrent medications[1][3].

Dosage Adjustments

Given the wide intersubject variability in theophylline metabolism, dosage adjustments must be made cautiously. Measurement of unbound serum theophylline concentrations is more reliable than total serum concentrations, especially in patients with reduced protein binding. Small increments in dose changes are recommended to achieve desired serum concentrations without risking adverse effects[1][3].

Safety and Contraindications

Contraindications

Theophylline is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product. Solutions containing dextrose are also contraindicated in patients with known allergies to corn or corn products[1][3].

Warnings and Precautions

The drug should be used with extreme caution in patients with active peptic ulcer disease, seizure disorders, cardiac arrhythmias, and other conditions that may be exacerbated by theophylline. Reduced theophylline clearance due to various clinical conditions requires careful monitoring and adjustment of infusion rates[1][3].

Key Takeaways

• Efficacy: Theophylline in 0.16% solution with 5% dextrose is effective in managing acute exacerbations of asthma and COPD.
• Market Growth: The global theophylline market is projected to grow at a CAGR of 6.50% from 2024 to 2031.
• Regional Dominance: North America and Europe are the leading markets, with significant growth expected in the Asia Pacific region.
• Pharmacokinetics: Careful dosage adjustments are necessary due to the variability in theophylline metabolism.
• Safety: The drug is contraindicated in patients with hypersensitivity and requires caution in those with certain clinical conditions.

FAQs

What is the therapeutic range for serum theophylline concentrations?

The therapeutic range for serum theophylline concentrations is between 5-20 mcg/mL, with clinically important improvements typically requiring concentrations greater than 10 mcg/mL[1][3].

What are the primary indications for theophylline in 5% dextrose injection?

The primary indications are as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of asthma and other chronic lung diseases, such as emphysema and chronic bronchitis[1][3].

How is theophylline metabolized and eliminated?

Approximately 90% of the theophylline dose is metabolized in the liver through N-demethylation and hydroxylation pathways, with the majority excreted as metabolites in the urine[1][3].

What are the contraindications for theophylline in 5% dextrose injection?

The drug is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product, and in those with known allergies to corn or corn products[1][3].

What precautions should be taken when using theophylline in patients with concurrent illnesses?

Theophylline should be used with extreme caution in patients with active peptic ulcer disease, seizure disorders, cardiac arrhythmias, and other conditions that may be exacerbated by the drug[1][3].

Sources

1. FDA Label: Theophylline in 5% Dextrose Injections USP - accessdata.fda.gov
2. Cognitive Market Research: Theophylline Market Report 2024 - cognitivemarketresearch.com
3. FDA Label: Theophylline in Dextrose Injection, Solution - accessdata.fda.gov