You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 24, 2025

CLINICAL TRIALS PROFILE FOR THEOPHYLLINE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Theophylline

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NCT00000577 ↗ Asthma Clinical Research Network (ACRN) Withdrawn National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1993-09-01 This study will establish a network of interactive asthma clinical research groups to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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Theophylline

Condition Name

Condition Name for Theophylline
Intervention Trials
Asthma 22
Chronic Obstructive Pulmonary Disease 9
COPD 8
Lung Diseases 6
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Theophylline
Intervention Trials
Asthma 20
Lung Diseases 18
Pulmonary Disease, Chronic Obstructive 18
Lung Diseases, Obstructive 14
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Theophylline

Trials by Country

Trials by Country for Theophylline
Location Trials
United States 141
China 24
Japan 19
Canada 13
United Kingdom 12
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Theophylline
Location Trials
California 13
Colorado 11
Texas 10
Missouri 9
Tennessee 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Theophylline

Clinical Trial Phase

Clinical Trial Phase for Theophylline
Clinical Trial Phase Trials
Phase 4 20
Phase 3 19
Phase 2/Phase 3 5
[disabled in preview] 21
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Theophylline
Clinical Trial Phase Trials
Completed 68
Unknown status 14
Recruiting 11
[disabled in preview] 9
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Theophylline

Sponsor Name

Sponsor Name for Theophylline
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 10
The First Affiliated Hospital of Guangzhou Medical University 4
Boehringer Ingelheim 4
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Theophylline
Sponsor Trials
Other 126
Industry 31
NIH 13
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Theophylline: Clinical Trials, Market Analysis, and Projections

Introduction to Theophylline

Theophylline, a bronchodilator, has been used for decades to treat respiratory conditions such as chronic obstructive pulmonary disease (COPD) and asthma. Despite its long history, the drug's efficacy and safety profile, particularly at low doses, have been subjects of ongoing research and debate.

Clinical Trials Update

Efficacy of Low-Dose Theophylline in COPD

A significant clinical trial published in JAMA investigated the effectiveness of low-dose theophylline in reducing COPD exacerbations. The study involved 1567 participants with COPD who were already using inhaled corticosteroids. Participants were randomized to receive either low-dose theophylline (200 mg once or twice per day) or a placebo. The results showed that the addition of theophylline did not significantly reduce the mean number of exacerbations compared to the placebo group over a 1-year period[1].

Adverse Events and Safety

The same study highlighted that while theophylline did not reduce exacerbations, it was associated with several adverse events, including cardiac, gastrointestinal issues, nausea, and headaches. These findings align with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, which do not recommend the use of theophylline unless other long-term treatment bronchodilators are unavailable or unaffordable[1].

Market Analysis

Global Market Size and Growth

The global theophylline market is expected to experience steady growth driven by the increasing prevalence of respiratory diseases such as COPD and asthma. As of 2024, the global theophylline market size is estimated to be USD 451.5 million, with a projected compound annual growth rate (CAGR) of 6.50% from 2024 to 2031, reaching USD 701.62 million by 2031[2].

Regional Market Dynamics

North America currently dominates the theophylline market, holding over 40% of the global revenue with a market size of USD 180.6 million in 2024. This region is expected to grow at a CAGR of 4.7% from 2024 to 2031. Europe and Asia-Pacific also hold significant market shares, with Europe expected to grow at a CAGR of 5.0% and Asia-Pacific at a CAGR of 8.5% during the same period[2].

Market Segmentation

The theophylline market is segmented based on application (asthma, insomnia, other), product form (injection, tablet, capsule), and geographical regions. The rising incidence of respiratory conditions, particularly COPD and asthma, is a key driver of the market. Continuous research and development aimed at improving drug formulations and delivery systems also contribute to market growth[3].

Market Projections

Future Growth Trajectory

The global theophylline market is poised for significant development, driven by the increasing global incidence of respiratory illnesses. By 2031, the market is expected to reach USD 660.1 million, growing at a CAGR of 6% from 2024 to 2031. This growth is attributed to the widespread use of theophylline as a bronchodilator, improved drug formulations, and increasing healthcare access in various regions[3].

Competitive Landscape

The competitive landscape of the theophylline market includes several key players and is influenced by factors such as buyers' bargaining power, suppliers' bargaining power, the threat of new entrants, the threat of substitutes, and the degree of competition. Strategic partnerships between pharmaceutical companies and healthcare providers are also crucial in expanding market reach and ensuring greater access to theophylline pharmaceuticals[3].

Key Takeaways

  • Clinical Efficacy: Low-dose theophylline does not significantly reduce COPD exacerbations, according to recent clinical trials.
  • Market Size: The global theophylline market is estimated to be USD 451.5 million in 2024 and is projected to grow to USD 701.62 million by 2031.
  • Regional Growth: North America, Europe, and Asia-Pacific are key regions driving market growth, with Asia-Pacific expected to have the highest CAGR.
  • Market Drivers: The increasing prevalence of respiratory diseases, improved drug formulations, and expanding healthcare access are primary drivers of the market.
  • Competitive Landscape: The market is characterized by a mix of established players and emerging competitors, with strategic partnerships playing a crucial role.

FAQs

What is the current status of theophylline in treating COPD?

Theophylline, particularly at low doses, has been found not to significantly reduce COPD exacerbations in recent clinical trials. However, it remains an option when other treatments are unavailable or unaffordable[1].

How is the global theophylline market expected to grow?

The global theophylline market is expected to grow at a CAGR of 6.50% from 2024 to 2031, reaching USD 701.62 million by 2031, driven by the increasing prevalence of respiratory diseases and improvements in drug formulations[2].

Which regions dominate the theophylline market?

North America currently dominates the theophylline market, followed by Europe and Asia-Pacific. Asia-Pacific is expected to have the highest growth rate during the projected period[2].

What are the main drivers of the theophylline market?

The main drivers include the rising incidence of respiratory conditions like COPD and asthma, demographic factors such as aging populations, environmental pollution, and continuous research and development in pharmaceuticals[3].

Are there any ongoing clinical trials for theophylline or related treatments?

Yes, there are ongoing clinical trials, such as the one for eosinophilic asthma, which is exploring new therapies to reduce asthma exacerbations. However, these trials are not specifically focused on theophylline but rather on other treatments for severe asthma[4].

References

  1. AJMC: Low-Dose Theophylline Not Effective at Reducing COPD Exacerbations, Study Finds.
  2. Cognitive Market Research: The global Theophylline market size will be USD 451.5 million in 2024.
  3. Market Research Intellect: Theophylline Market Size, Trends and Projections.
  4. Mater Research: Nimble - Possible new medicine for Adults and Adolescents with Eosinophilic Asthma.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.