CLINICAL TRIALS PROFILE FOR CROMOLYN SODIUM

All Clinical Trials for Cromolyn Sodium

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NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to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NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	Milton S. Hershey Medical Center	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current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.
NCT00000622 ↗	Prevention of Early Asthma in Kids (PEAK)	Completed	Childhood Asthma Research and Education Network	N/A	2001-01-01	To evaluate current and novel therapies and management strategies for children with asthma. The emphasis is on clinical trials that help identify optimal therapy for children with different asthma phenotypes, genotypes, and ethnic backgrounds and children at different developmental stages.

Clinical Trial Conditions for Cromolyn Sodium

Condition Name

Condition Name for Cromolyn Sodium
Intervention	Trials
Asthma	7
Lung Diseases	5
Bronchial Asthma	3
Ischemic Stroke	1

Condition MeSH

Condition MeSH for Cromolyn Sodium
Intervention	Trials
Asthma	10
Lung Diseases	5
Respiratory Aspiration	2
Idiopathic Pulmonary Fibrosis	2

Clinical Trial Locations for Cromolyn Sodium

Trials by Country

Trials by Country for Cromolyn Sodium
Location	Trials
United States	46
Australia	5
United Kingdom	4
Ukraine	3
Poland	3

Trials by US State

Trials by US State for Cromolyn Sodium
Location	Trials
California	9
North Carolina	3
Missouri	3
Colorado	3
Wisconsin	2

Clinical Trial Progress for Cromolyn Sodium

Clinical Trial Phase

Clinical Trial Phase for Cromolyn Sodium
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	7
Phase 2	7

Clinical Trial Status

Clinical Trial Status for Cromolyn Sodium
Clinical Trial Phase	Trials
Completed	16
Terminated	3
Not yet recruiting	2

Clinical Trial Sponsors for Cromolyn Sodium

Sponsor Name

Sponsor Name for Cromolyn Sodium
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	7
Chiesi Farmaceutici S.p.A.	3
Childhood Asthma Research and Education Network	3

Sponsor Type

Sponsor Type for Cromolyn Sodium
Sponsor	Trials
Other	19
Industry	13
NIH	9

Cromolyn Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Cromolyn sodium, a well-known anti-inflammatory drug, has been widely used for treating various conditions, including allergic asthma, allergic rhinitis, and ulcerative colitis. Recent studies have also explored its potential in neuroprotective roles, particularly in the context of amyotrophic lateral sclerosis (ALS). Here, we delve into the latest clinical trials, market analysis, and projections for cromolyn sodium.

Clinical Trials and Efficacy

Asthma and Respiratory Conditions

Cromolyn sodium has been extensively studied and proven effective in controlling asthmatic symptoms. A multicenter evaluation using a metered-dose inhaler (MDI) showed that cromolyn sodium significantly improved lung functions, reduced symptoms such as cough and breathlessness, and decreased the need for concomitant bronchodilators[4].

Irritable Bowel Syndrome (IBS)

In the context of IBS, cromolyn sodium has demonstrated promising results. Studies have shown that oral cromolyn can reduce symptoms in patients with diarrhea-predominant IBS, with response rates comparable to or even better than those achieved with elimination diets[3].

Amyotrophic Lateral Sclerosis (ALS)

A groundbreaking study by Massachusetts General Hospital revealed that cromolyn sodium delayed the onset of disease symptoms and provided neuroprotection in a mouse model of ALS. The treatment reduced inflammation and protected neurons from degeneration, suggesting a potential role for anti-inflammatory therapies in ALS management[1].

Market Analysis

Current Market Size and Growth

The global cromolyn sodium market is experiencing significant growth, driven by its diverse applications. The market size is projected to increase at a compound annual growth rate (CAGR) of 3 to 5% from 2023 to 2031, with an estimated valuation in the millions of USD[2][5].

Segmentation and Key Applications

The market is segmented based on application (allergic asthma, allergic rhinitis, ulcerative colitis) and product forms (dosage forms, etc.). Geographically, the market spans North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. The eye drops segment is expected to expand significantly, retaining its position throughout the forecast period[2][5].

Key Players and Market Dynamics

Companies such as Cambrex and JSN Chemicals are focusing on strengthening their product portfolios and expanding their business globally. Market dynamics are influenced by drivers such as increasing demand for high-quality and environmentally friendly products, and restraints such as regulatory challenges and competition from alternative treatments[5].

Market Projections

Forecast Period

From 2023 to 2031, the cromolyn sodium market is anticipated to witness sustained and significant expansion. The positive outlook is supported by emerging trends, pivotal factors steering market dynamics, and the increasing adoption of cromolyn sodium in various therapeutic areas[2][5].

Regional Analysis

The market analysis includes a comprehensive regional assessment, highlighting growth opportunities and challenges in different geographical regions. North America and Europe are expected to remain key markets, while the Asia-Pacific region is projected to show rapid growth due to increasing healthcare expenditure and awareness[2][5].

Technological Advancements

The production of high-quality cromolyn sodium API is being driven by technological advancements. Manufacturers are focusing on improving the manufacturing process and raw material quality to meet the growing demand for this compound[5].

Key Takeaways

• Clinical Efficacy: Cromolyn sodium has shown efficacy in treating asthma, IBS, and potentially ALS, highlighting its broad therapeutic potential.
• Market Growth: The global market is expected to grow at a CAGR of 3 to 5% from 2023 to 2031, driven by increasing demand and technological advancements.
• Segmentation: The market is segmented by application and product form, with the eye drops segment expected to expand significantly.
• Regional Outlook: North America and Europe are key markets, while the Asia-Pacific region is projected to show rapid growth.

FAQs

What are the primary uses of cromolyn sodium?

Cromolyn sodium is primarily used to treat allergic asthma, allergic rhinitis, and ulcerative colitis. Recent studies also explore its potential in treating ALS.

How effective is cromolyn sodium in treating asthma?

Cromolyn sodium is highly effective in controlling asthmatic symptoms, improving lung functions, and reducing the need for concomitant bronchodilators[4].

What are the findings of the ALS study involving cromolyn sodium?

The study found that cromolyn sodium delayed the onset of disease symptoms and provided neuroprotection in a mouse model of ALS, suggesting a potential role for anti-inflammatory therapies in ALS management[1].

What is the projected growth rate of the cromolyn sodium market?

The market is expected to grow at a CAGR of 3 to 5% from 2023 to 2031[2][5].

Which segment is expected to expand significantly in the cromolyn sodium market?

The eye drops segment is expected to expand significantly and retain its position throughout the forecast period[5].

Sources

1. Massachusetts General Hospital. "Cromolyn sodium delays disease onset and is neuroprotective in the SOD1G93A mouse model of ALS." Press Release, November 27, 2019.
2. Market Research Intellect. "Global Cromolyn Sodium Market Size and Forecast."
3. JAMA Internal Medicine. "A Systematic Review of Alternative Therapies in the Irritable Bowel Syndrome."
4. PubMed. "A multicenter evaluation of the clinical benefits of cromolyn sodium by MDI."
5. Cognitive Market Research. "Cromolyn Sodium API Market Report 2024 (Global Edition)."

Last updated: 2025-01-01