CLINICAL TRIALS PROFILE FOR VENTOLIN

505(b)(2) Clinical Trials for Ventolin

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
New Dosage	NCT01323010 ↗	Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	N/A	2011-09-01	Metered dose inhalers with spacers are devices capable of providing higher rates of lung deposition of drugs such as beta agonists when compared to conventional nebulizers, but there is no consensus about the optimal dose when this is the device of choice and there is evidence that younger children need proportionally higher doses of albuterol (in μg/kg) when compared to older children. Other factors that may interfere with response to albuterol treatment include the genetics of the beta adrenergic receptor (ADRβ2) and infectious etiology of the wheezing attack. This study will assess the effectiveness of a dose regimen that prioritizes higher doses of albuterol, with doses in μg/kg higher for younger children. Security of this new dosing regimen will be assessed by monitoring clinical side effects and serum levels of albuterol, but the investigators will also examine the presence of 12 different respiratory viruses in these patients and evaluate the influence of ADRβ2 receptor genetics in the response to albuterol. The primary outcome measure will be the need for hospitalization. Secondary outcomes will include a change in clinical score, respiratory rate and forced expiratory volume in the first second, the need for additional treatments and length of stay in the emergency room for those not hospitalized.
New Dosage	NCT01323010 ↗	Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes	Completed	University of Sao Paulo	N/A	2011-09-01	Metered dose inhalers with spacers are devices capable of providing higher rates of lung deposition of drugs such as beta agonists when compared to conventional nebulizers, but there is no consensus about the optimal dose when this is the device of choice and there is evidence that younger children need proportionally higher doses of albuterol (in μg/kg) when compared to older children. Other factors that may interfere with response to albuterol treatment include the genetics of the beta adrenergic receptor (ADRβ2) and infectious etiology of the wheezing attack. This study will assess the effectiveness of a dose regimen that prioritizes higher doses of albuterol, with doses in μg/kg higher for younger children. Security of this new dosing regimen will be assessed by monitoring clinical side effects and serum levels of albuterol, but the investigators will also examine the presence of 12 different respiratory viruses in these patients and evaluate the influence of ADRβ2 receptor genetics in the response to albuterol. The primary outcome measure will be the need for hospitalization. Secondary outcomes will include a change in clinical score, respiratory rate and forced expiratory volume in the first second, the need for additional treatments and length of stay in the emergency room for those not hospitalized.
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	Simbec Research	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	AstraZeneca	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.

All Clinical Trials for Ventolin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00102882 ↗	Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate	Completed	GlaxoSmithKline	Phase 4	2004-10-01	This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done during the study. Study medicines and procedures will be provided at no cost. Patients will be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and older.
NCT00180843 ↗	Assessment of Ventilation-perfusion Abnormalities in Patients With Stable Smoking-related Airways Disease	Terminated	GlaxoSmithKline	N/A	2005-09-01	Subjects undergo history, examination, lung function assessment after informed consent has been obtained. All subjects will undergo ventilation-perfusion scans. If there first scan is normal they will undergo a second and final scan four weeks later. If abnormal they will undergo two further scans with either nebulized bronchodilator or nebulized saline prior to their second and third scans. Each time they will have repeat lung function tests prior to scanning. We will examine the regional changes in ventilation and perfusion and there relationship to lung function.
NCT00180843 ↗	Assessment of Ventilation-perfusion Abnormalities in Patients With Stable Smoking-related Airways Disease	Terminated	Imperial College London	N/A	2005-09-01	Subjects undergo history, examination, lung function assessment after informed consent has been obtained. All subjects will undergo ventilation-perfusion scans. If there first scan is normal they will undergo a second and final scan four weeks later. If abnormal they will undergo two further scans with either nebulized bronchodilator or nebulized saline prior to their second and third scans. Each time they will have repeat lung function tests prior to scanning. We will examine the regional changes in ventilation and perfusion and there relationship to lung function.
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.

Clinical Trial Conditions for Ventolin

Condition Name

Condition Name for Ventolin
Intervention	Trials
Asthma	22
COPD	3
Chronic Obstructive Pulmonary Disease	3
Asthma in Children	3

Condition MeSH

Condition MeSH for Ventolin
Intervention	Trials
Asthma	23
Pulmonary Disease, Chronic Obstructive	5
Fibrosis	4
Lung Diseases, Obstructive	4

Clinical Trial Locations for Ventolin

Trials by Country

Trials by Country for Ventolin
Location	Trials
United States	61
Canada	9
United Kingdom	7
China	4
Taiwan	3

Trials by US State

Trials by US State for Ventolin
Location	Trials
New York	5
Oregon	4
California	3
Texas	3
North Carolina	3

Clinical Trial Progress for Ventolin

Clinical Trial Phase

Clinical Trial Phase for Ventolin
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	14
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Ventolin
Clinical Trial Phase	Trials
Completed	34
Terminated	5
Not yet recruiting	4

Clinical Trial Sponsors for Ventolin

Sponsor Name

Sponsor Name for Ventolin
Sponsor	Trials
GlaxoSmithKline	8
AstraZeneca	4
Imperial College London	2

Sponsor Type

Sponsor Type for Ventolin
Sponsor	Trials
Other	57
Industry	28
NIH	1

VENTOLIN: Clinical Trials, Market Analysis, and Projections

Introduction to VENTOLIN

VENTOLIN, also known as salbutamol or albuterol, is a widely used medication for treating respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). It is administered via a metered dose inhaler (MDI) and is crucial for the management of symptoms like wheezing, difficulty breathing, and chest tightness.

Clinical Trials Update

Phase III Trials for Low-Carbon VENTOLIN

GSK has announced a significant milestone in its sustainability efforts with the advancement of its low-carbon VENTOLIN programme to Phase III trials. This new version of the MDI uses a next-generation propellant designed to reduce greenhouse gas emissions by approximately 90%[1][2].

• Trial Timeline: The Phase III trials are scheduled to start in the first half of 2024, with dosing of the first patients planned during this period. If successful, regulatory submissions are expected to begin in 2025[1][2].
• Propellant Technology: The next-generation propellant has undergone extensive testing to ensure its suitability for MDIs and patient use. Early clinical trials have supported the decision to progress to Phase III[1][2].

Market Analysis

Global Albuterol Market

The global albuterol market is experiencing significant growth driven by several key factors:

• Increasing Prevalence of Respiratory Diseases: The rising prevalence of asthma, COPD, and bronchitis is driving the demand for albuterol. This market was valued at USD 4587.68 million in 2022 and is projected to reach USD 7984.37 million by 2030, with a CAGR of 6.80%[3].
• Growing Awareness and Diagnosis: Improved awareness and diagnostic techniques have led to early detection and better management of respiratory conditions, increasing the number of patients prescribed albuterol[3].
• Lifestyle Changes: Modern lifestyles, including sedentary habits, poor dietary choices, and exposure to environmental pollutants, contribute to the development and exacerbation of respiratory diseases, further boosting the demand for albuterol[3].

Market Segmentation and Drivers

• Dosage Forms: The oral dosage segment dominates the market, but inhalers, particularly MDIs and dry powder inhalers (DPIs), are also significant. The market is driven by the need for effective management of respiratory diseases and the convenience of inhaler devices[3].
• Combination Therapies: Combination therapies incorporating albuterol with other medications offer enhanced efficacy and simplified treatment regimens, providing opportunities for market growth[3].
• Technological Advancements: Innovations in drug delivery systems, such as smart inhalers and next-generation propellants, are enhancing patient compliance and efficiency, further driving the market[3].

Challenges and Restraints

Regulatory Requirements

The development and commercialization of albuterol medications are subject to stringent regulatory requirements. Compliance with these regulations involves significant time, resources, and costs, posing challenges for market players[3].

Side Effects and Safety Concerns

Although albuterol is generally safe, it can have side effects such as increased heart rate, tremors, and nervousness. Rare but severe adverse reactions can also occur, impacting patient perception and acceptance[3].

Sustainability Efforts

GSK’s Sustainability Ambitions

GSK’s initiative to develop a low-carbon VENTOLIN is part of its broader sustainability strategy. The current propellant used in VENTOLIN accounts for 49% of GSK’s carbon footprint, making this transition crucial for the company’s net-zero targets. GSK aims to reduce its carbon emissions by 80% by 2030 and by 90% by 2045, investing £1 billion between 2020 and 2030 to achieve these goals[1][2].

Industry-Wide Sustainability Initiatives

Other pharmaceutical companies, such as AstraZeneca and Novo Nordisk, are also focusing on sustainability. AstraZeneca’s Ambition Zero Carbon program includes developing next-generation respiratory inhalers with minimal environmental impact, while Novo Nordisk’s PenCycle program repurposes spent insulin pens into office furniture[2].

Market Projections

Potential Impact of Low-Carbon VENTOLIN

If GSK’s low-carbon VENTOLIN is successful, it could significantly reduce greenhouse gas emissions associated with the use of this medication. Given that VENTOLIN is prescribed to approximately 35 million patients globally, this reduction could have a substantial environmental impact[1][2].

Market Opportunities

• Peak Sales Potential: The new low-carbon albuterol pMDI, such as the one being developed by DevPro Biopharma and Bespak, has the potential to generate peak sales in excess of $500 million USD annually, based on market research[5].
• Global Demand: With over 60 million prescriptions written annually for albuterol pMDIs in the US alone, the demand for a low-GWP (Global Warming Potential) albuterol pMDI is significant, offering a large market opportunity[5].

Key Takeaways

• Clinical Trials: GSK is advancing its low-carbon VENTOLIN programme to Phase III trials, aiming for regulatory submissions in 2025.
• Market Growth: The global albuterol market is projected to grow significantly, driven by increasing prevalence of respiratory diseases and technological advancements.
• Sustainability: The development of low-carbon inhalers is a critical step towards reducing the environmental impact of pharmaceutical products.
• Market Opportunities: The potential for peak sales in excess of $500 million annually highlights the significant market opportunity for low-carbon albuterol inhalers.

FAQs

1. What is the current status of GSK’s low-carbon VENTOLIN trials?

GSK is set to start Phase III trials of its low-carbon VENTOLIN in the first half of 2024, with regulatory submissions planned for 2025 if the trials are successful[1][2].

2. How significant is the reduction in greenhouse gas emissions expected from the new VENTOLIN?

The new VENTOLIN is expected to reduce greenhouse gas emissions by approximately 90%, significantly contributing to GSK’s sustainability targets[1][2].

3. What is driving the growth of the global albuterol market?

The growth is driven by the increasing prevalence of respiratory diseases, growing awareness and diagnosis, lifestyle changes, and government initiatives and healthcare expenditure[3].

4. What are the challenges associated with developing and commercializing albuterol medications?

The challenges include stringent regulatory requirements and potential side effects and safety concerns associated with albuterol use[3].

5. How does the development of low-carbon inhalers fit into the broader sustainability efforts of pharmaceutical companies?

The development of low-carbon inhalers is part of a broader strategy by pharmaceutical companies to reduce their carbon footprint. Companies like GSK, AstraZeneca, and Novo Nordisk are investing heavily in sustainability initiatives, including greener production facilities and sustainable drug delivery devices[2].

Cited Sources:

1. GSK announces major step towards sustainability ambitions with advancement of low carbon Ventolin programme to Phase III trials. GSK. Retrieved November 21, 2023.
2. GSK aims to slash carbon emissions with next-generation inhaler. FiercePharma. Retrieved November 21, 2023.
3. Global Albuterol Market – Industry Trends and Forecast to 2030. Data Bridge Market Research.
4. VENTOLIN HFA. FDA. Retrieved May 11, 2024.
5. Early feasibility studies on climate-friendly albuterol inhaler completed. News-Medical. Retrieved May 11, 2024.