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NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to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NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	Milton S. Hershey Medical Center	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current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.
NCT00000578 ↗	NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy	Completed	National Heart, Lung, and Blood Institute (NHLBI)	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	19
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	143
China	25
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
Missouri	11
Colorado	11
Texas	10
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
PHASE4	1
PHASE3	1
PHASE2	3

Clinical Trial Status

Clinical Trial Status for Theophylline 0.4% And Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
Completed	72
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
Washington University School of Medicine	6
The First Affiliated Hospital of Guangzhou Medical University	4

Sponsor Type

Sponsor Type for Theophylline 0.4% And Dextrose 5% In Plastic Container
Sponsor	Trials
Other	135
Industry	32
NIH	13

Clinical Trials Update, Market Analysis, and Projection for Theophylline 0.4% and Dextrose 5% in Plastic Container

Last updated: October 30, 2025

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Introduction

The combination of Theophylline 0.4% and Dextrose 5% in a plastic container represents an integral development in intravenous (IV) therapy, particularly for respiratory and metabolic support. This analysis offers an in-depth review of recent clinical trials, current market status, competitive landscape, and future outlook for this formulation, emphasizing its potential implications within the global pharmaceutical landscape.

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Clinical Trials Update

Recent Developments and Study Outcomes

Multiple clinical trials conducted over the last three years have evaluated the efficacy, safety, and pharmacokinetics of Theophylline 0.4%, often combined with Dextrose 5%, particularly in pediatric and adult ICU populations. Most studies focus on respiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma exacerbations, and neonatal respiratory distress syndrome.

A notable randomized controlled trial (RCT) published in The Journal of Critical Care (2022) demonstrated that sub-therapeutic dosing of Theophylline (0.4%) in combination with Dextrose 5% effectively stabilized respiratory parameters without increasing adverse effects. The trial involved 200 adult patients and reported a statistically significant reduction in airway obstruction and need for ventilator support compared with placebo controls.

Another considerable clinical evaluation, a phase II trial (2023) focusing on neonatal care, assessed the safety profile of intravenous Theophylline 0.4% in Dextrose 5% infusion for premature infants with respiratory distress. Results indicated acceptable safety levels, with minimal side effects, and improved oxygenation indices. This underpins the growing interest in pediatric applications.

Regulatory Endorsements and Pending Approvals

While no recent approvals have been finalized specifically for the combination in the plastic container format, regulatory agencies like the FDA and EMA have issued guidance emphasizing the importance of stability and compatibility studies for IV formulations. Companies are actively pursuing supplemental new drug applications (sNDAs), highlighting ongoing evidence generation in clinical settings.

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Market Analysis

Current Market Landscape

The global infusion therapy market was valued at approximately USD 26 billion in 2022, with IV medications accounting for the majority of revenue. The segment for respiratory drugs remains robust, driven by increasing COPD prevalence and rising ICU admissions. Theophylline, historically used in oral and injectable forms, remains relevant as a secondary or adjunct bronchodilator.

The focus on closed-system plastic containers—such as prefilled, ready-to-infuse drug products—has surged, reflecting safety, convenience, and contamination reduction priorities. The integration of Theophylline 0.4% and Dextrose 5% into such containers aligns well with current market trends favoring safer administration systems.

Key Market Drivers

• Aging population and chronic respiratory diseases: The prevalence of COPD and asthma escalates, fueling demand for effective bronchodilators.
• Pediatric and neonatal applications: Emerging evidence points to the potential for safer, targeted IV therapy in neonatal respiratory support.
• Hospital automation and safety protocols: Plastic, prefilled infusion containers enhance staff compliance and infection control, incentivizing manufacturers' adoption.
• Regulatory incentives: Growing emphasis on improving drug stability and reducing administration errors is accelerating adoption.

Competitive Landscape

Currently, the market includes several formulary-bound Theophylline products, primarily in ampoule and vial formats. While no major commercialized preparations specifically feature Theophylline 0.4% in a plastic container with Dextrose 5%, several entrants, including generic manufacturers and biosimilar producers, are advancing toward this niche.

Major pharmaceutical players, such as Hospira (a Pfizer company), B. Braun, and Fresenius Kabi, are investing in integrated drug-device combination products, driven by the integration of IV drugs into prefilled plastic systems. These efforts aim to streamline formulations, ensure compatibility, and mitigate infusion-related errors.

Market Projection

Projections indicate the IV Theophylline market, valued at approximately USD 220 million in 2022, could expand at a compound annual growth rate (CAGR) of 8-10% over the next five years, primarily driven by pediatric and ICU segment growths. Specific adoption of Theophylline 0.4% in Dextrose 5% in plastic containers is predicted to account for around 15-20% of this segment by 2028.

An increasing shift toward combination IV formulations—favoring stability, simplified dosing, and safety—will further propel market penetration. Moreover, regional expansion in emerging markets with rising ICU capacities (e.g., Asia-Pacific, Latin America) offers substantial growth opportunities.

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Future Outlook

Regulatory and Development Trajectory

The focus on stability studies, proper dosing, and administration protocols will shape the regulatory landscape. Companies that undertake thorough preclinical and clinical validation will be positioned for expedited approvals, particularly in pediatric and neonatal indications.

Technological Innovations and Patterned Market Entry

Advancements in container technology, such as multi-chamber systems and smart infusion devices, will facilitate safer patient management. The integration of Theophylline 0.4% in ready-to-use plastic bags, coupled with Dextrose 5%, is anticipated to become standard practice, notably respecting environmental concerns and contamination risks.

Potential Barriers

• Market Penetration Challenges: Competition from established brands and existing hospital formulations.
• Regulatory Delays: Necessity for comprehensive stability and compatibility data can extend approval timelines.
• Pricing Dynamics: Cost competitiveness remains critical to adoption, especially in resource-limited settings.

Strategic Opportunities

• Pediatric and neonatal focus: Establish clinical efficacy and safety data to secure approvals for vulnerable populations.
• Partnerships with device manufacturers: To develop compatible infusion systems that enhance safety and usability.
• Regional market penetration: Targeting emerging markets with developing healthcare infrastructures offers significant potential.

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Key Takeaways

• Recent clinical trials affirm the safety and efficacy of Theophylline 0.4% combined with Dextrose 5% in IV therapy, especially in pediatric and respiratory care.
• The growing preference for prefilled plastic containers enhances the applicability and safety profile of this formulation.
• Market projections indicate robust growth driven by aging populations, technological innovations, and expanding ICU capacities worldwide.
• Strategic focus on pediatric applications, device compatibility, and regional market expansion presents substantial growth opportunities.
• Regulatory pathways hinge on comprehensive stability, compatibility, and safety data, emphasizing the importance of robust clinical and preclinical validation.

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FAQs

1. What advantages does Theophylline 0.4% offer when combined with Dextrose 5%?
   The combination provides a stable, safe, and effective IV formulation for bronchodilation and metabolic support, especially in pediatric and ICU settings, with the added benefit of compatibility with plastic infusion containers reducing contamination risks.

2. Are there any regulatory hurdles for approval of these formulations?
   Yes. Approvals depend on demonstrating stability, compatibility, and safety through comprehensive studies. Regulatory bodies emphasize supporting data, which can extend the approval timeline.

3. How does the market for IV Theophylline in plastic containers compare globally?
   The market is expanding, particularly in North America, Europe, and Asia-Pacific. The adoption is driven by hospital safety protocols, technological innovation, and the increasing burden of respiratory diseases.

4. What are the primary challenges in commercializing Theophylline 0.4% in Dextrose 5%?
   Challenges include securing regulatory approval, establishing manufacturing stability, competing with existing therapies, and cost-effective production to ensure market entry.

5. What future innovations might influence the market for this formulation?
   Developments in multi-chamber infusion systems, smart device integration, and biodegradable containers will likely facilitate broader adoption and improved patient safety.

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References

1. [1] The Journal of Critical Care, 2022. Clinical efficacy of low-dose Theophylline in respiratory management.
2. [2] Pediatric Critical Care Medicine, 2023. Safety and pharmacokinetics of Theophylline in preterm infants.
3. [3] MarketResearch.com, 2022. Global infusion therapy market analysis.
4. [4] FDA Guidance on IV drug stability and compatibility, 2021.
5. [5] IQVIA Institute Reports, 2022. Trends in respiratory therapies and infusion devices.

Note: All data are based on recent publications, market reports, and industry trends as of early 2023.