CLINICAL TRIALS PROFILE FOR IPRATROPIUM BROMIDE

505(b)(2) Clinical Trials for Ipratropium Bromide

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00480194 ↗	Evaluation of Safety of ZyComb® In Patients With Common Cold - ZIP 3000 (XY-005-IM)	Completed	Nycomed		2006-12-01	The objectives of the study are to obtain knowledge about the safety in use, the patients' general impression of the treatment and the pattern of use of ZyComb® in an over-the-counter (OTC) setting.

All Clinical Trials for Ipratropium Bromide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000568 ↗	Lung Health Study (LHS) I and III	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1984-09-01	In the Lung Health Study I, to determine the effects of Special Care, compared to Usual Care, on rate of decline in pulmonary function in a group of cigarette smokers identified as having mild abnormalities in pulmonary function. In the Lung Health Study III, to determine the long-term effects of smoking cessation and continued smoking, on cardiopulmonary morbidity, mortality, and the rate of decline in the one second forced expiratory volume (FEV1) in men and women with early chronic obstructive lung disease who have been followed prospectively for 12 to 15 years.
NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to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NCT00000577 ↗	Asthma Clinical Research Network (ACRN)	Withdrawn	Milton S. Hershey Medical Center	Phase 3	1993-09-01	This study will establish a network of interactive asthma clinical research groups to evaluate current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.
NCT00200967 ↗	Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)	Completed	Asthma Clinical Research Network	Phase 3	2004-12-01	The purpose of this trial is to determine whether regularly scheduled use of an inhaled long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly genotype.
NCT00200967 ↗	Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	2004-12-01	The purpose of this trial is to determine whether regularly scheduled use of an inhaled long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly genotype.
NCT00200967 ↗	Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)	Completed	Milton S. Hershey Medical Center	Phase 3	2004-12-01	The purpose of this trial is to determine whether regularly scheduled use of an inhaled long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly genotype.

Clinical Trial Conditions for Ipratropium Bromide

Condition Name

Condition Name for Ipratropium Bromide
Intervention	Trials
Asthma	24
Pulmonary Disease, Chronic Obstructive	16
Chronic Obstructive Pulmonary Disease	11
COPD	7

Condition MeSH

Condition MeSH for Ipratropium Bromide
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	37
Lung Diseases	33
Lung Diseases, Obstructive	27
Asthma	22

Clinical Trial Locations for Ipratropium Bromide

Trials by Country

Trials by Country for Ipratropium Bromide
Location	Trials
United States	114
Canada	11
Germany	7
China	6
United Kingdom	6

Trials by US State

Trials by US State for Ipratropium Bromide
Location	Trials
California	8
New York	7
North Carolina	7
Missouri	6
Colorado	5

Clinical Trial Progress for Ipratropium Bromide

Clinical Trial Phase

Clinical Trial Phase for Ipratropium Bromide
Clinical Trial Phase	Trials
Phase 4	28
Phase 3	23
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Ipratropium Bromide
Clinical Trial Phase	Trials
Completed	60
Terminated	6
Unknown status	6

Clinical Trial Sponsors for Ipratropium Bromide

Sponsor Name

Sponsor Name for Ipratropium Bromide
Sponsor	Trials
Boehringer Ingelheim	23
GlaxoSmithKline	5
National Heart, Lung, and Blood Institute (NHLBI)	4

Sponsor Type

Sponsor Type for Ipratropium Bromide
Sponsor	Trials
Other	77
Industry	45
NIH	4

Ipratropium Bromide: Clinical Trials, Market Analysis, and Projections

Introduction to Ipratropium Bromide

Ipratropium bromide is a small molecule drug that belongs to the class of muscarinic acetylcholine receptor (mAChR) antagonists. It is primarily used in the treatment of various respiratory diseases, including bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, and asthma. Developed by Boehringer Ingelheim GmbH, ipratropium bromide has been approved globally since 1986 and is widely recognized for its efficacy in bronchodilation and improving the quality of life for patients with respiratory conditions[3].

Clinical Trials and Efficacy

Recent Clinical Trials

A recent randomized trial investigated the addition of ipratropium bromide to albuterol in the treatment of acute asthma exacerbations in children. The study found that both the ipratropium bromide-treated group and the placebo group showed similar improvements in clinical asthma scores during the first 36 hours. There were no significant differences in oxygen saturation or forced expiratory volume (FEV1) between the groups. However, the study highlighted that intensive ipratropium bromide treatment, in addition to albuterol and corticosteroids, is most effective when delivered early in the treatment of an acute asthma exacerbation[1].

Comparative Studies

A multi-center, double-blind study compared ipratropium bromide with metaproterenol in patients with asthma. The results indicated that both drugs were equally effective as bronchodilators, although ipratropium bromide had a slower onset of action and a more prolonged duration. The study noted that the only significant side effects associated with ipratropium bromide were cough and exacerbation of symptoms, with no anticholinergic side effects observed[4].

Market Analysis

Market Size and Growth

The pharmaceutical-grade ipratropium bromide market was valued at approximately USD 300 million in 2022 and is projected to reach around USD 450 million by 2030, indicating a Compound Annual Growth Rate (CAGR) of approximately 5.5% over the forecast period. This growth is driven by the rising prevalence of respiratory diseases such as asthma and COPD, as well as the increasing adoption of ipratropium bromide due to its efficacy in bronchodilation[2].

Regional Analysis

The market is analyzed across key regions, including North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.

• North America: Characterized by high adoption rates of innovative technologies and significant R&D investments.
• Europe: Driven by stringent environmental regulations and growing consumer awareness, particularly in countries like Germany and France.
• Asia-Pacific: The fastest-growing region, fueled by rapid industrialization, urbanization, and an expanding consumer base in countries such as China and India.
• Latin America: Showing moderate growth, driven by infrastructural development and increasing disposable income.
• Middle East & Africa: Growth is propelled by government-led diversification initiatives and increased spending on technology[2].

Market Dynamics

The market dynamics are influenced by several factors:

• Drivers: Increasing prevalence of respiratory diseases, efficacy of ipratropium bromide in bronchodilation, and growing consumer awareness.
• Restraints: Potential side effects such as cough and exacerbation of symptoms, and competition from other bronchodilators.
• Opportunities: Expanding consumer base in emerging markets and advancements in delivery technologies.
• Challenges: Regulatory hurdles and the need for continuous R&D to maintain market competitiveness[5].

Market Projections

Forecast Period

From 2023 to 2031, the ipratropium bromide market is expected to undergo significant growth. The market size is projected to increase substantially, driven by the sustained expansion in the demand for respiratory treatments.

Segmentation

The market is segmented based on type (purity ≥98% and purity <98%) and application (aerosol and inhalation solution). Geographical regions also play a crucial role in market segmentation, with North America, Europe, Asia-Pacific, South America, and the Middle East & Africa being key areas of focus[5].

Competitive Landscape

The competitive landscape of the ipratropium bromide market includes several key players, with Boehringer Ingelheim GmbH being the originator and a major player. The market is characterized by intense competition, with companies focusing on R&D, innovative delivery technologies, and strategic partnerships to maintain market share[2].

Key Takeaways

• Ipratropium bromide is a widely used and effective treatment for respiratory diseases, with global approvals since 1986.
• Clinical trials have shown that ipratropium bromide is as effective as other bronchodilators, with a slower onset and longer duration of action.
• The market is expected to grow at a CAGR of approximately 5.5% from 2022 to 2030, driven by increasing demand for respiratory treatments.
• Regional analysis highlights the Asia-Pacific region as the fastest-growing market due to rapid industrialization and urbanization.
• Market dynamics are influenced by factors such as the prevalence of respiratory diseases, efficacy of the drug, and regulatory environments.

FAQs

What is ipratropium bromide used for?

Ipratropium bromide is used in the treatment of various respiratory diseases, including bronchitis, COPD, emphysema, and asthma. It works by targeting muscarinic acetylcholine receptors to relax and widen the airways, thereby improving breathing and alleviating symptoms[3].

What are the side effects of ipratropium bromide?

The significant side effects noted with ipratropium bromide include cough and exacerbation of symptoms. However, no anticholinergic side effects have been reported in most studies[4].

How does ipratropium bromide compare to other bronchodilators?

Ipratropium bromide has been shown to be as effective as other bronchodilators, such as metaproterenol, although it has a slower onset of action and a more prolonged duration[4].

What is the projected market size of ipratropium bromide by 2030?

The pharmaceutical-grade ipratropium bromide market is projected to reach around USD 450 million by 2030, indicating a CAGR of approximately 5.5% from 2022 to 2030[2].

Which region is expected to be the fastest-growing market for ipratropium bromide?

The Asia-Pacific region is expected to be the fastest-growing market for ipratropium bromide, driven by rapid industrialization, urbanization, and an expanding consumer base in countries such as China and India[2].

Sources

1. Randomized Trial of the Addition of Ipratropium Bromide to Albuterol: JAMA Pediatrics, 2023.
2. Pharmaceutical Grade Ipratropium Bromide Market: GitHub, 2024.
3. An In-depth Analysis of Ipratropium Bromide's R&D Progress: Synapse, 2023.
4. Use of Ipratropium Bromide in Asthma: PubMed, 1988.
5. Global Ipratropium Bromide Market Size, Trends and Projections: Market Research Intellect, 2024.

Last updated: 2024-12-31