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

Last Updated: May 21, 2025

CLINICAL TRIALS PROFILE FOR IPRATROPIUM BROMIDE


✉ Email this page to a colleague

« Back to Dashboard


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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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NCT00000577 ↗ Asthma Clinical Research Network (ACRN) Withdrawn National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1993-09-01 This study will establish a network of interactive asthma clinical research groups to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NCT00000577 ↗ Asthma Clinical Research Network (ACRN) Withdrawn Milton S. Hershey Medical Center Phase 3 1993-09-01 This study will establish a network of interactive asthma clinical research groups to evaluate current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

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
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Ipratropium Bromide
Intervention Trials
Pulmonary Disease, Chronic Obstructive 37
Lung Diseases 33
Lung Diseases, Obstructive 27
Asthma 22
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 20
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Ipratropium Bromide
Clinical Trial Phase Trials
Completed 60
Terminated 6
Unknown status 6
[disabled in preview] 13
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Ipratropium Bromide
Sponsor Trials
Other 77
Industry 45
NIH 4
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

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

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.