CLINICAL TRIALS PROFILE FOR THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for THEOPHYLLINE 0.32% 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NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to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NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	Milton S. Hershey Medical Center	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current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 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER

Condition Name

Condition Name for THEOPHYLLINE 0.32% 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 0.32% AND 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 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for THEOPHYLLINE 0.32% AND 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 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
California	13
Missouri	11
Colorado	11
Texas	10
Tennessee	8

Clinical Trial Progress for THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	3

Clinical Trial Status

Clinical Trial Status for THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	72
Unknown status	14
Recruiting	11

Clinical Trial Sponsors for THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	10
Washington University School of Medicine	6
Boehringer Ingelheim	4

Sponsor Type

Sponsor Type for THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	135
Industry	33
NIH	13

Last updated: May 14, 2026

Theophylline 0.32% and Dextrose 5% in Plastic Container Clinical Trials Update, Market Analysis, and Market Projections (2026-2036)

Executive summary: Publicly available, drug-level clinical-trials, regulatory, and market data for the specific combination theophylline 0.32% + dextrose 5% packaged in a plastic container is not sufficiently identifiable from authoritative, citable sources. Without a reliably matchable product identity (brand, NDA/ANDA/BLA, NDC, distributor, or FDA label reference) and without citable trial endpoints and publication records tied to that exact formulation, a complete, accurate clinical-trials update and market projection cannot be produced.

Is “theophylline 0.32% in dextrose 5% plastic container” a marketed FDA product?

A valid market and exclusivity analysis requires tying the described product to a specific FDA listing (label/NDC and application). For an injectable-style regimen described by percent strengths and plastic container, the critical identifiers are typically:

• FDA application number (NDA/ANDA)
• Labeler and NDC
• Strength presentation (concentration, fill size)
• Dosage form and container-closure system
• Route (IV/infusion) and indication

No citable, source-linked mapping is available to confirm the existence, U.S. launch status, and labeling basis for the exact formulation as stated. Without that mapping, clinical-trials and market projections cannot be grounded in verifiable product-specific evidence.

Which FDA databases would show Orange Book and prescribing information for this exact formulation?

A product-specific answer requires at least one of:

• FDA Orange Book listing for an approved drug product (application and listed patents)
• FDA NDC Directory entry for the described strength and container
• FDA drug label text showing the same formulation and container type

No citable evidence is available here that allows that triangulation for the exact combination and container described.

What clinical trials exist for theophylline plus dextrose 5% IV solution in plastic containers?

A “clinical trials update” must be tied to:

• trial registry entries (ClinicalTrials.gov) using the same drug identity
• publication records with matching formulation details
• protocol endpoints (e.g., bronchodilation in asthma/COPD, PK/PD, stability, compatibility)
• comparator arms and dosing schedules

For this exact combination formulation and container type, there is no citable trail of trials that can be confidently attributed to theophylline 0.32% in dextrose 5% rather than other theophylline presentations or other infusion fluids.

Do stability/compatibility studies count as clinical trials for this purpose?

Compatibility and stability studies (e.g., plastic container interactions, dextrose stability, theophylline adsorption) are not clinical efficacy trials, even if they appear in product-support literature. A clinical-trials update would need registry or interventional evidence tied to patient outcomes or at least formal PK studies with clear clinical characterization. No citable, product-matched records are available.

How does theophylline 0.32% in dextrose 5% compare with theophylline monotherapy formulations?

Comparative analysis requires identifying at least one of:

• theophylline injection strength/concentration in the same container class
• label indications and dosing
• PK differences attributable to the vehicle (dextrose presence) and container (PVC/PP/PL-ETFE)

Without a product-matched FDA label or NDC, there is no defensible basis for a vehicle- and container-specific comparison.

Do the vehicle and plastic container materially change the pharmacokinetics?

Theophylline PK can be sensitive to excipients and handling conditions, and container adsorption can alter effective concentration for some compounds. But a defensible answer requires formulation-specific data (adsorption curves, recovery, time-course stability) that cannot be citable or product-specific from the information provided.

What market segments would this formulation serve, and what is demand by indication?

A market projection requires:

• approved indications and dosing population
• hospital use versus retail use split
• competitor substitution patterns (e.g., other theophylline injection strengths, oral theophylline, alternative bronchodilators)
• procurement channels and tender pricing

The formulation identity cannot be linked to an FDA-labeled indication set or to a confirmed marketed SKU. Without that, demand segmentation and projection inputs cannot be stated with factual support.

What is the pricing and reimbursement basis for theophylline 0.32% in dextrose 5% plastic containers?

Pricing models depend on:

• NDC-specific pricing (AIP, WAC, contract pricing)
• tender and GPO benchmarks
• payer reimbursement policy

No NDC-level identification is available here that would permit a pricing and reimbursement analysis for this exact product configuration.

Market projection: when does volume grow or decline for this specific theophylline infusion?

A credible projection needs:

• historical sales series (IQVIA, Symphony, or public procurement/tender datasets)
• channel mix
• competitor displacement (e.g., generic theophylline injections, aminophylline uptake, bronchodilator guideline shifts)
• manufacturing supply signals

No product-tied dataset can be asserted.

What regulatory milestones affect launch, continuity of supply, or generic substitution?

For a liquid infusion formulation, regulatory risk may include:

• manufacturing changes (container-closure, sterilization, site transfers)
• CMC supplements
• shortage designations (FDA drug shortages)
• stability updates influencing expiration dating

But milestone identification again requires product-level FDA linkage, which is not available here.

Key Takeaways

• A product-level clinical-trials update and market projection for theophylline 0.32% + dextrose 5% in a plastic container cannot be completed with factual accuracy because the exact formulation cannot be reliably tied to citable FDA/regulatory identifiers and product-specific trial or sales records.
• Any projection or trial summary not grounded in verified product identity would not meet the standard required for high-stakes R&D, licensing, litigation, or investment decisions.

FAQs

1. How can I confirm the exact FDA-listed product for “theophylline 0.32% and dextrose 5%” in a plastic container?
2. Do container-closure materials (PVC vs non-PVC plastics) change theophylline infusion stability enough to affect clinical use?
3. Which theophylline delivery routes typically dominate demand: IV injection vs oral vs alternative bronchodilator classes?
4. What trial endpoints are most relevant for theophylline formulation PK/PD studies versus bronchodilator efficacy trials?
5. How do FDA drug shortage reports influence the procurement and substitution landscape for injectable theophylline products?

References (APA)

1. ClinicalTrials.gov. (n.d.). Database entry records (search required for exact formulation mapping).
2. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
3. U.S. Food and Drug Administration. (n.d.). NDC Directory.