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

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NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to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NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	Milton S. Hershey Medical Center	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current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

Condition Name

Condition Name for Theophylline In 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 In Dextrose 5% In Plastic Container
Intervention	Trials
Asthma	21
Lung Diseases	19
Pulmonary Disease, Chronic Obstructive	18
Lung Diseases, Obstructive	14

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

Trials by Country

Trials by Country for Theophylline In Dextrose 5% In Plastic Container
Location	Trials
United States	143
China	26
Japan	19
Canada	13
United Kingdom	12

Trials by US State

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

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

Clinical Trial Phase

Clinical Trial Phase for Theophylline In Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	3

Clinical Trial Status

Clinical Trial Status for Theophylline In Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
COMPLETED	72
Unknown status	14
Recruiting	11

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

Sponsor Name

Sponsor Name for Theophylline In Dextrose 5% In Plastic Container
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	10
Washington University School of Medicine	6
AstraZeneca	4

Sponsor Type

Sponsor Type for Theophylline In Dextrose 5% In Plastic Container
Sponsor	Trials
Other	135
Industry	33
NIH	13

Theophylline In Dextrose 5% In Plastic Container Market Analysis and Financial Projection

Last updated: April 28, 2026

Clinical trials update, market analysis and projection: Theophylline in Dextrose 5% in plastic container

What is the drug product and how is it positioned commercially?

Theophylline in Dextrose 5% in plastic container is an IV formulation combining:

• Theophylline (a methylxanthine bronchodilator used in obstructive airway diseases), and
• Dextrose 5% (commonly D5W) as the infusion vehicle, packaged in plastic containers.

Market positioning (practical view)
This product is typically supplied as a sterile hospital-administered medicine where demand tracks:

• hospital use of IV bronchodilation during acute exacerbations,
• product availability and supply continuity (IV stock-outs materially shift usage to alternatives),
• payer/provider procurement cycles for branded and generic stock.

Theophylline is a well-established active ingredient with substantial history of generic availability in multiple IV and oral forms. An IV D5W presentation in plastic container is usually treated as a form-factor and packaging-specific SKU, not a standalone “new chemical entity.”

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What clinical-trial activity exists for the exact formulation (theophylline in D5% IV, plastic container)?

No complete, formulation-specific clinical-trial dataset for theophylline in dextrose 5% in plastic container can be produced from the available information in this context without introducing unsupported claims.

High-level, theophylline as a molecule has ongoing and historical clinical study across respiratory indications, but trial activity for the exact IV formulation and packaging is not reliably inferable from molecule-level data. A formulation-specific update must be tied to registry entries explicitly matching the product name, salt form, dosage form, route, and investigational formulation.

Result: a formulation-matched clinical-trials update cannot be generated with integrity under the constraints.

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What is the addressable market (demand drivers) for this IV theophylline SKU?

Even without a formulation-matched trials map, commercial demand for IV theophylline generally correlates with these use cases:

• Acute exacerbations of asthma and COPD where IV bronchodilation is chosen when oral routes are impractical or when rapid titration is required.
• Hospital and emergency department protocols that include methylxanthines as add-on therapy after inhaled therapies and systemic corticosteroids.
• ICU and step-up settings where clinicians may prefer IV bronchodilators for patients who cannot take oral medicines.

Demand driver structure

• Acute episode incidence drives baseline usage.
• Guideline-concordant substitution drives variation: many institutions prioritize inhaled beta-agonists and anticholinergics, then consider IV options.
• Safety monitoring requirements for theophylline (narrower therapeutic window than many bronchodilators) can limit adoption relative to alternatives in some settings.
• Supply continuity and pricing pressure shape procurement more than differentiated clinical claims.

Commercial implication: Theophylline IV SKUs behave like mature hospital generics, where market outcomes track tender dynamics, stocking policies, and replacementability across IV bronchodilator classes.

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How big is the market and what is the projection path?

A numeric market size and forecast for this exact presentation (theophylline in dextrose 5% in plastic container) cannot be generated without formulation-specific sales reporting, regulatory submission-level mapping, or validated payer/wholesaler datasets.

A molecule-level view is possible in principle, but producing a SKU-level projection would require source-grade linkage between:

• formulation-specific product catalogs,
• country-level tender and wholesaler sales,
• and the packaging-specific item codes.

Result: a rigorous market projection cannot be produced under the constraints.

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What competitive landscape matters for this product?

For a mature IV theophylline product, the competitive set usually comes from:

• Other IV theophylline presentations (different infusion media, container types, and strengths),
• Alternative IV bronchodilators used in acute airway disease pathways (for example, IV beta-agonists or other systemic bronchodilators where local protocols favor them),
• Oral-to-IV switching availability during supply constraints.

Procurement reality

• Hospitals typically standardize on a small set of IV bronchodilator SKUs.
• Packaging matters operationally (nursing handling, line compatibility, storage stability requirements).
• Price and supply reliability dominate differentiation for mature hospital medicines.

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What milestones and signals should investors watch?

Without formulation-matched clinical trials or SKU-level sales visibility, the highest-value signals are operational and regulatory:

1. Regulatory filings tied to this exact dosage form and container
   • new listings, changes in packaging, label updates.
2. Tender outcomes and hospital formulary renewals
   • switching behavior is more predictive than molecule-level activity.
3. Supply chain events
   • shortages and manufacturing disruptions can temporarily shift market share across formulations.
4. Safety and use-pattern updates
   • adverse event reporting trends influence institutional comfort and utilization.

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Key Takeaways

• This is a mature hospital IV formulation defined by a combination of active ingredient (theophylline), infusion vehicle (D5W), and packaging (plastic container).
• A formulation-specific clinical trials update for “theophylline in dextrose 5% in plastic container” cannot be produced without introducing unsupported detail.
• SKU-level market sizing and projections cannot be produced without formulation-specific sales or catalog mapping.
• Commercial outcomes for this type of product track tender dynamics, protocol substitution, safety monitoring practices, and supply continuity more than differentiated science.

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FAQs

1) Is the product a new-generation theophylline therapy?

No. Theophylline is a mature active ingredient. The product’s differentiator is the IV formulation and container format, not a new drug class.

2) Why does packaging (plastic container) matter commercially?

Hospitals and distributors treat packaging as an operational SKU element. It can affect handling, compatibility, inventory management, and procurement contracts.

3) Do clinical trials for theophylline automatically translate to this exact IV presentation?

No. Trials for theophylline in other dosage forms or infusion media do not automatically validate equivalence for this specific product.

4) What most influences demand for IV theophylline?

Hospital acute care use patterns and protocol selection, plus availability and procurement price.

5) What is the most practical forecast approach for this SKU?

A SKU-level forecast requires formulation-matched product catalog mapping and sales/tender data. Without those inputs, projections cannot be created from generic theophylline demand alone.

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References

1. [No citable sources were provided in the request context.]