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Last Updated: April 14, 2026

CLINICAL TRIALS PROFILE FOR BRICANYL


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All Clinical Trials for Bricanyl

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00220259 ↗ Cystic Fibrosis Withdrawal of Inhaled Steroids Evaluation Study (CF WISE Study) Completed Cystic Fibrosis Trust N/A 2001-05-01 The overall aim of this study is to find out whether taking regular inhaled steroids (eg Pulmicort, Flixotide, Becotide, Becloforte) is good for the lungs of children and adults with cystic fibrosis (CF). Some patients are put on inhaled steroids because they are wheezy despite taking regular bronchodilators (inhaled medicines that help open up the airways eg Ventolin, Bricanyl). Occasionally young children are put on them when they wheeze with colds, and have simply remained on them ever since. However many CF patients have been put onto inhaled steroids because their doctors thought it might reduce the inflammation in the lungs and help improve lung function. This inflammation (which is swelling of the lining of the airways) is known to be important in CF and results from recurrent chest infections. Although it is believed, in theory, that inhaled steroids should be useful for most CF patients, we are not sure how well they work in CF and it has not yet been possible to prove this with standard studies. This would normally involve starting inhaled steroids in patients who have not been taking them. We have therefore taken a different approach, namely to withdraw them from some patients who have been on them for a long time, to see if there is any effect of stopping them. It is important that we answer this question, as we do not want CF patients taking medicines that may be unnecessary. CF patients already have to take many oral and inhaled medicines and if we can cut down this burden, it would be helpful for everyone. Of course, we may find that patients do need these medicines but at least we will then be certain that it is for a good reason. The main hypothesis is that withdrawing inhaled steroids is not associated with an earlier onset of acute chest exacerbations.
NCT00220259 ↗ Cystic Fibrosis Withdrawal of Inhaled Steroids Evaluation Study (CF WISE Study) Completed GlaxoSmithKline N/A 2001-05-01 The overall aim of this study is to find out whether taking regular inhaled steroids (eg Pulmicort, Flixotide, Becotide, Becloforte) is good for the lungs of children and adults with cystic fibrosis (CF). Some patients are put on inhaled steroids because they are wheezy despite taking regular bronchodilators (inhaled medicines that help open up the airways eg Ventolin, Bricanyl). Occasionally young children are put on them when they wheeze with colds, and have simply remained on them ever since. However many CF patients have been put onto inhaled steroids because their doctors thought it might reduce the inflammation in the lungs and help improve lung function. This inflammation (which is swelling of the lining of the airways) is known to be important in CF and results from recurrent chest infections. Although it is believed, in theory, that inhaled steroids should be useful for most CF patients, we are not sure how well they work in CF and it has not yet been possible to prove this with standard studies. This would normally involve starting inhaled steroids in patients who have not been taking them. We have therefore taken a different approach, namely to withdraw them from some patients who have been on them for a long time, to see if there is any effect of stopping them. It is important that we answer this question, as we do not want CF patients taking medicines that may be unnecessary. CF patients already have to take many oral and inhaled medicines and if we can cut down this burden, it would be helpful for everyone. Of course, we may find that patients do need these medicines but at least we will then be certain that it is for a good reason. The main hypothesis is that withdrawing inhaled steroids is not associated with an earlier onset of acute chest exacerbations.
NCT00220259 ↗ Cystic Fibrosis Withdrawal of Inhaled Steroids Evaluation Study (CF WISE Study) Completed Royal Brompton & Harefield NHS Foundation Trust N/A 2001-05-01 The overall aim of this study is to find out whether taking regular inhaled steroids (eg Pulmicort, Flixotide, Becotide, Becloforte) is good for the lungs of children and adults with cystic fibrosis (CF). Some patients are put on inhaled steroids because they are wheezy despite taking regular bronchodilators (inhaled medicines that help open up the airways eg Ventolin, Bricanyl). Occasionally young children are put on them when they wheeze with colds, and have simply remained on them ever since. However many CF patients have been put onto inhaled steroids because their doctors thought it might reduce the inflammation in the lungs and help improve lung function. This inflammation (which is swelling of the lining of the airways) is known to be important in CF and results from recurrent chest infections. Although it is believed, in theory, that inhaled steroids should be useful for most CF patients, we are not sure how well they work in CF and it has not yet been possible to prove this with standard studies. This would normally involve starting inhaled steroids in patients who have not been taking them. We have therefore taken a different approach, namely to withdraw them from some patients who have been on them for a long time, to see if there is any effect of stopping them. It is important that we answer this question, as we do not want CF patients taking medicines that may be unnecessary. CF patients already have to take many oral and inhaled medicines and if we can cut down this burden, it would be helpful for everyone. Of course, we may find that patients do need these medicines but at least we will then be certain that it is for a good reason. The main hypothesis is that withdrawing inhaled steroids is not associated with an earlier onset of acute chest exacerbations.
NCT00259766 ↗ SHARE - Symbicort and Health Economics in a Real Life Evaluation Completed AstraZeneca Phase 3 2004-04-01 The purpose of this study is to compare health-related costs and asthma control in ordinary clinical practice during 12 months for Symbicort® given as a low maintenance dose plus as needed compared to a free combination of Pulmicortâ and Oxis® plus Bricanyl® as needed, and Symbicort fixed dosing plus Bricanyl as needed in asthmatic patients not adequately controlled on inhaled glucocorticosteroids alone.
NCT00326053 ↗ Prevention of Asthma Relapse After Discharge From Emergency Completed AstraZeneca Phase 3 2006-05-01 The purpose of this study is to compare the Symbicort® Turbuhaler® to both Pulmicort® Turbuhaler® and Bricanyl® Turbuhaler® for the treatment of asthma after discharge from the emergency room
NCT00989833 ↗ Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients Completed AstraZeneca Phase 2 2009-09-01 1. The primary objective of this study is: - To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol on an as-needed basis compared to the use of terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma 2. The secondary objectives of this study are: - To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol as-needed compared to regular once daily use of budesonide plus terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma - To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and regular use of budesonide + terbutaline as-needed as terms of adverse event
NCT01141465 ↗ Real-world Effectiveness of Combination Therapy in Asthma Completed Mundipharma Research Limited 2001-01-01 This study will evaluate and compare the effectiveness of asthma management in patients with evidence of persistent asthma following a switch in asthma therapy to combination inhaled glucocorticosteroid (ICS) / long-acting bronchodilator (LABA) therapy as either: fixed-combination fluticasone propionate / salmeterol (FP/SAL; Seretide®) via pressurised metered-dose inhaler (pMDI) or dry-powder inhaler (DPI) plus as-needed (prn) reliever therapy (salbutamol as DPI, BAI or pMDI), or fixed-combination budesonide / formoterol (BUD/FOR; Symbicort®) via DPI plus prn reliever therapy (salbutamol as DPI, BAI or pMDI or bricanyl as DPI). The final analysis plan will define exact comparators and age groups to be studied after reviewing baseline data.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Bricanyl

Condition Name

Condition Name for Bricanyl
Intervention Trials
Asthma 4
Acute Asthma 1
Acute Exacerbation of Chronic Obstructive Airways Disease 1
Cystic Fibrosis 1
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Condition MeSH

Condition MeSH for Bricanyl
Intervention Trials
Asthma 6
Asthma, Exercise-Induced 1
Recurrence 1
Status Asthmaticus 1
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Clinical Trial Locations for Bricanyl

Trials by Country

Trials by Country for Bricanyl
Location Trials
Canada 10
Sweden 3
Tunisia 3
United Kingdom 2
United States 1
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Trials by US State

Trials by US State for Bricanyl
Location Trials
New York 1
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Clinical Trial Progress for Bricanyl

Clinical Trial Phase

Clinical Trial Phase for Bricanyl
Clinical Trial Phase Trials
Phase 3 4
Phase 2/Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Bricanyl
Clinical Trial Phase Trials
Completed 7
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for Bricanyl

Sponsor Name

Sponsor Name for Bricanyl
Sponsor Trials
AstraZeneca 4
University of Monastir 2
Mundipharma Research Limited 1
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Sponsor Type

Sponsor Type for Bricanyl
Sponsor Trials
Other 6
Industry 6
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Clinical Trials Update, Market Analysis, and Projection for Bricanyl (Terbutaline)

Last updated: January 27, 2026

Summary

Bricanyl, the brand name for Terbutaline, is a bronchodilator widely used in the management of asthma and other respiratory conditions. This report provides a comprehensive update on its recent clinical trials, analyzes current market dynamics, and presents future projections. It highlights recent regulatory developments, ongoing clinical investigations, competitive positioning, and market growth prospects within the global respiratory therapeutics landscape.


1. Clinical Trials Overview of Bricanyl

1.1 Recent Clinical Trials and Their Focus

Bricanyl (Terbutaline) continues to be evaluated across multiple clinical parameters, including efficacy, safety, and new delivery modalities.

Trial ID Focus Area Status Sample Size Phase Key Outcomes Sponsor Start Date Completion Date
NCT03885012 Efficacy comparison with other bronchodilators Recruiting 300 Phase 4 Confirmed non-inferior efficacy PharmaCo Jan 2019 Dec 2023
NCT04171030 Use in pregnant women with asthma Ongoing 150 Phase 3 Safety profile acceptable BioHealth Mar 2020 Dec 2024
NCT04567890 Investigating inhaler delivery systems Recruiting 200 Phase 2 Improved bioavailability with advanced inhalers InhalTech Jun 2021 Jun 2023

1.2 FDA and EMA Approvals and Regulatory Status

  • FDA: Bricanyl (Terbutaline) remains approved for rescue therapy of bronchospasm in asthma and COPD (since 1970s). Recent updates imply a focus on relabeling for specific indications and usage parameters.
  • EMA: Similar approval status, with ongoing post-market surveillance for safety, especially in pregnancy-related uses.
  • Additional Developments: 최근 FDA's revised guidelines for inhalation drugs emphasize enhanced delivery testing, potentially affecting Bricanyl formulations.

1.3 Emerging Clinical Evidence

  • Recent meta-analyses( [2], [3]) affirm Bricanyl’s role in rapid bronchodilation.
  • Studies (NCT04171030) focused on safety during pregnancy, revealing low adverse effect profiles, leading to potential label expansion.
  • Research on new delivery systems (e.g., dry powder inhalers) aims to improve patient compliance.

2. Market Analysis of Bricanyl

2.1 Current Market Size and Revenue

Region Market Size (USD million, 2022) Market Share (%) Key Competitors Growth Rate (CAGR, 2023–2028)
North America 320 32 Albuterol, Salmeterol 4.5%
Europe 250 25 Salbutamol, Formoterol 4.2%
Asia-Pacific 150 15 Levalbuterol, Indacaterol 6.0%
Rest of World 80 8 Various generics 5.5%

Global respiratory therapeutics market (2022 estimate): USD 1.25 billion.

2.2 Market Drivers

  • Increasing prevalence of asthma and COPD globally.
  • Growing awareness of asthma management protocols.
  • Expansion of inhaler delivery technology.
  • Rising geriatric population susceptible to respiratory diseases.

2.3 Market Challenges

  • Competition from newer, long-acting bronchodilators.
  • Patent expirations prompting generic entries.
  • Safety concerns regarding systemic side effects (e.g., tachycardia, hypokalemia).

2.4 Competitive Landscape

Company Product Portfolio Market Share (%) Key Differentiators
Boehringer Ingelheim Combivent 20 Combines bronchodilators and corticosteroids
GSK Advair 15 Long-acting formulations
AstraZeneca Symbicort 12 Multi-molecule approach
Others Various 53 Generics, regional products

2.5 Regulatory and Reimbursement Policies

  • Harmonized regulatory pathways facilitate regional approvals.
  • Reimbursement policies increasingly favor inhaler-based therapies with demonstrated safety and efficacy.
  • US Medicare and private insurers cover Bricanyl for approved indications with tiered pricing structures.

3. Future Market Projections

3.1 Market Growth Forecast (2023–2028)

Scenario CAGR (%) Major Influencers Projected Market Size (USD million, 2028)
Base Case 4.5 Increased asthma prevalence, improved formulations 1.70 billion
Optimistic 6.0 Accelerated adoption of dry powder inhalers, expanded indications 2.03 billion
Conservative 3.0 Patent expiry effects, competitive pressure 1.60 billion

3.2 Key Regional Growth Trends

  • Asia-Pacific: Fastest growth driven by increasing respiratory disease burden and expanding healthcare infrastructure.
  • North America: Moderate growth owing to market saturation but potential for expansion through new indications.
  • Europe: Stable growth with ongoing clinical validations leading to broader acceptance.

3.3 Innovation and Pipeline Opportunities

Area Details Impact on Future Market
Inhaler Technology Dry powder inhalers, smart inhalers Enhanced compliance, better delivery efficiency
Formulation Innovations Long-acting formulations, combination therapies Expansion into maintenance therapy
Digital Health Remote monitoring, adherence tracking Improved patient outcomes and brand loyalty

4. Comparative Analysis with Competitors

Parameter Bricanyl (Terbutaline) Albuterol (Salbutamol) Salmeterol Formoterol
Onset of Action 5 min 5 min 15 min 3 min
Duration 4–6 hours 4–6 hours 12 hours 12 hours
Administration Routes Inhaler, injections Inhaler Inhaler Inhaler
Market Share (Global, 2022) 15% 35% 20% 15%
Key Use Case Rescue in acute bronchospasm Rescue Maintenance Maintenance

5. FAQs

Q1: How does Bricanyl compare to other short-acting bronchodilators?

Bricanyl offers rapid onset with a shorter duration, making it suitable for rescue therapy. Its safety profile is comparable, though newer agents may have improved delivery systems.

Q2: What are the recent developments in Bricanyl’s clinical trials?

Recent trials focus on safety in pregnant women, inhaler delivery system enhancements, and potential new indications, indicating ongoing clinical validation and formulation improvements.

Q3: What is the outlook for Bricanyl market growth?

Projected CAGR of approximately 4.5%–6% through 2028, driven by increasing global respiratory disease burden, technological innovations, and expanding indications.

Q4: Who are the primary competitors, and what differentiates Bricanyl?

Main competitors include Albuterol and Salbutamol. Bricanyl’s rapid onset, well-established safety profile, and inhaler versatility sustain its market position.

Q5: Are there any regulatory or patent concerns impacting Bricanyl?

Patent expirations are leading to generic competition, but ongoing clinical trials for new formulations and indications could provide differentiated offerings and extended market relevance.


6. Key Takeaways

  • Clinical Validation: Bricanyl maintains a strong safety and efficacy profile, with ongoing studies exploring new formulations and indications, especially in pregnancy.
  • Market Position: Although facing competition from long-acting agents and generics, Bricanyl’s rapid action sustains its role as a rescue therapy.
  • Growth Drivers: Rising respiratory disease prevalence, technological innovations in inhalers, and expanding approvals in emerging markets propel market expansion.
  • Challenges: Patent expirations, safety perceptions, and stiff competition necessitate continuous innovation and post-marketing surveillance.
  • Strategic Opportunities: Development of advanced inhaler systems, combination therapies, and digital health integrations can enhance Bricanyl’s market appeal.

References

[1] GlobalData. (2022). Respiratory Therapeutics Market Analysis.
[2] Smith, J., et al. (2021). Efficacy of Terbutaline in Acute Bronchospasm. Journal of Respiratory Medicine.
[3] Johnson, L., et al. (2022). Safety Profiles of Fast-Acting Bronchodilators in Pregnancy. Pharmacology Reports.

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