CLINICAL TRIALS PROFILE FOR CAYSTON

All Clinical Trials for Cayston

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01746095 ↗	Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients	Completed	Cystic Fibrosis Foundation	Phase 2	2013-03-01	The purpose of this study is to determine whether AeroVanc treatment is safe and effective in reducing the number of MRSA colony forming units in the lungs of cystic fibrosis patients.
NCT01746095 ↗	Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients	Completed	Cystic Fibrosis Foundation Therapeutics	Phase 2	2013-03-01	The purpose of this study is to determine whether AeroVanc treatment is safe and effective in reducing the number of MRSA colony forming units in the lungs of cystic fibrosis patients.
NCT01746095 ↗	Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients	Completed	Synteract, Inc.	Phase 2	2013-03-01	The purpose of this study is to determine whether AeroVanc treatment is safe and effective in reducing the number of MRSA colony forming units in the lungs of cystic fibrosis patients.
NCT01746095 ↗	Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients	Completed	Savara Inc.	Phase 2	2013-03-01	The purpose of this study is to determine whether AeroVanc treatment is safe and effective in reducing the number of MRSA colony forming units in the lungs of cystic fibrosis patients.
NCT02449031 ↗	Observational Study in Cystic Fibrosis Patients Using TOBI® Podhaler™ or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs	Active, not recruiting	Cystic Fibrosis Foundation		2015-05-05	This is a multicenter, prospective, two cohort, observational study over a 5-year period in Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection.The study will collect data over 1 year on respiratory function, antibacterial effectiveness, and clinical outcomes of treatment with inhaled antipseudomonal antibiotics and data over 5 years on microbiological and safety assessments.
NCT02449031 ↗	Observational Study in Cystic Fibrosis Patients Using TOBI® Podhaler™ or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs	Active, not recruiting	Cystic Fibrosis Foundation Therapeutics		2015-05-05	This is a multicenter, prospective, two cohort, observational study over a 5-year period in Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection.The study will collect data over 1 year on respiratory function, antibacterial effectiveness, and clinical outcomes of treatment with inhaled antipseudomonal antibiotics and data over 5 years on microbiological and safety assessments.
NCT02449031 ↗	Observational Study in Cystic Fibrosis Patients Using TOBI® Podhaler™ or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs	Active, not recruiting	Mylan Inc.		2015-05-05	This is a multicenter, prospective, two cohort, observational study over a 5-year period in Cystic Fibrosis (CF) patients with chronic Pseudomonas aeruginosa infection.The study will collect data over 1 year on respiratory function, antibacterial effectiveness, and clinical outcomes of treatment with inhaled antipseudomonal antibiotics and data over 5 years on microbiological and safety assessments.

Clinical Trial Conditions for Cayston

Condition Name

Condition Name for Cayston
Intervention	Trials
Cystic Fibrosis	3
Tracheostomy Infection	1
Bronchiectasis Adult	1
Infection	1

Condition MeSH

Condition MeSH for Cayston
Intervention	Trials
Fibrosis	4
Cystic Fibrosis	4
Pseudomonas Infections	3
Infections	1

Clinical Trial Locations for Cayston

Trials by Country

Trials by Country for Cayston
Location	Trials
United States	56
United Kingdom	2

Trials by US State

Trials by US State for Cayston
Location	Trials
California	3
South Carolina	2
Pennsylvania	2
Oklahoma	2
Ohio	2

Clinical Trial Progress for Cayston

Clinical Trial Phase

Clinical Trial Phase for Cayston
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Cayston
Clinical Trial Phase	Trials
Terminated	2
Active, not recruiting	2
Completed	2

Clinical Trial Sponsors for Cayston

Sponsor Name

Sponsor Name for Cayston
Sponsor	Trials
Gilead Sciences	2
Cystic Fibrosis Foundation	2
Cystic Fibrosis Foundation Therapeutics	2

Sponsor Type

Sponsor Type for Cayston
Sponsor	Trials
Other	11
Industry	6

Clinical Trials, Market Analysis, and Projections for CAYSTON

Introduction to CAYSTON

CAYSTON (aztreonam for inhalation solution) is a prescription antibiotic used to improve lung function and reduce the frequency of pulmonary exacerbations in patients with cystic fibrosis (CF) who have Pseudomonas aeruginosa (P. aeruginosa) infections. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

AIR-CF1 Study

The AIR-CF1 study was the primary clinical trial for CAYSTON, focusing on the improvement in respiratory symptoms and lung function. This study involved 80 patients treated with CAYSTON and 84 patients treated with a placebo. The results showed a statistically significant improvement in FEV1 (Forced Expiratory Volume in one second) and respiratory symptoms such as wheezing, coughing, and mucus production after 28 days of treatment. Even two weeks after treatment ended, patients on CAYSTON still reported significant improvements in these symptoms[4].

Active Comparator Study

In another significant study, CAYSTON was compared directly to Tobramycin Inhalation Solution (TOBI) over three treatment courses. This open-label study involved 136 patients taking CAYSTON and 132 patients taking TOBI. The results indicated that CAYSTON showed superiority over TOBI in terms of lung function improvement, measured by FEV1% predicted. On average, the change from baseline in FEV1% was 2.70% higher for those taking CAYSTON compared to those taking TOBI over the three treatment cycles[1].

Study 205-0110

Study 205-0110, a Phase III trial, further reinforced the efficacy of CAYSTON. This multicenter, randomized study involved 268 patients (136 on CAYSTON and 132 on TOBI) and demonstrated that CAYSTON was superior to TOBI in improving lung function and reducing respiratory symptoms over a six-month period. Patients on CAYSTON had an adjusted mean actual increase in FEV1% predicted of 2.05% compared to a 0.66% decrease for those on TOBI[3].

Safety and Adverse Effects

Common Side Effects

During these clinical trials, common side effects associated with CAYSTON included cough, nasal congestion, wheezing, pharyngolaryngeal pain, and pyrexia. However, the incidence of cough was lower in patients receiving CAYSTON compared to those receiving TOBI. Serious adverse events were reported by 16.2% of patients on CAYSTON and 8.3% of patients on TOBI, with cough and productive cough being the most common serious adverse events[1][3].

Market Analysis

Current Market Landscape

The global cystic fibrosis drugs market is experiencing significant growth, driven by the increasing prevalence of cystic fibrosis and the development of new treatments. The market is projected to grow from 2024 to 2031, with a notable increase in revenue and market share for drugs like CAYSTON. The market is segmented by region, with North America, Europe, and the Asia Pacific being key areas of focus[2].

Revenue and Growth Projections

The cystic fibrosis drugs market is expected to see substantial growth, with CAYSTON being a key player. The market size is estimated to increase significantly over the forecast period, driven by the efficacy and safety profile of CAYSTON, as well as increasing demand for effective treatments for cystic fibrosis. The compound annual growth rate (CAGR) for this market is anticipated to be robust, reflecting the growing need for advanced therapeutic options[2].

Competitive Landscape

Market Share and Competitors

CAYSTON competes in a market that includes other inhaled antibiotics such as TOBI. However, CAYSTON's superior efficacy in improving lung function and reducing respiratory symptoms has positioned it favorably in the market. Gilead Sciences, the manufacturer of CAYSTON, continues to invest in research and development, which is expected to further strengthen CAYSTON's market position[1][3].

Regulatory Approvals and Compliance

FDA and International Approvals

CAYSTON was approved by the U.S. Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA) in 2010. It also received conditional marketing authorizations in the European Union (EU) and Canada in 2009. These approvals were contingent upon the results of Phase III studies, which have since been submitted to regulatory agencies[3].

Future Projections

Market Expansion and Growth

Given the positive outcomes from clinical trials and the growing demand for effective cystic fibrosis treatments, CAYSTON is expected to continue its market growth. The drug's efficacy in improving lung function and reducing pulmonary exacerbations makes it a preferred choice for patients and healthcare providers. As the global cystic fibrosis drugs market expands, CAYSTON is poised to remain a significant player.

Potential for New Indications

Future research may explore additional indications for CAYSTON, potentially expanding its use beyond P. aeruginosa infections in cystic fibrosis patients. This could further enhance its market presence and contribute to the overall growth of the cystic fibrosis drugs market.

Key Takeaways

• Clinical Efficacy: CAYSTON has demonstrated superiority over TOBI in improving lung function and reducing respiratory symptoms in patients with cystic fibrosis.
• Market Growth: The global cystic fibrosis drugs market is projected to grow significantly, with CAYSTON expected to be a key contributor.
• Safety Profile: CAYSTON has a manageable safety profile, with common side effects including cough and nasal congestion.
• Regulatory Approvals: CAYSTON has received approvals from major regulatory bodies, including the FDA and EU.
• Future Potential: There is potential for CAYSTON to expand into new indications, further solidifying its market position.

FAQs

What is CAYSTON used for?

CAYSTON is used to improve lung function and reduce the frequency of pulmonary exacerbations in patients with cystic fibrosis who have Pseudomonas aeruginosa infections.

How does CAYSTON compare to TOBI?

CAYSTON has shown superiority over TOBI in improving lung function and reducing respiratory symptoms in clinical trials.

What are the common side effects of CAYSTON?

Common side effects include cough, nasal congestion, wheezing, pharyngolaryngeal pain, and pyrexia.

Is CAYSTON approved by regulatory agencies?

Yes, CAYSTON has been approved by the FDA, TGA, and has received conditional marketing authorizations in the EU and Canada.

What is the projected market growth for CAYSTON?

The global cystic fibrosis drugs market, including CAYSTON, is expected to grow significantly from 2024 to 2031, driven by increasing demand and the drug's efficacy.

Sources

1. Active Comparator Study | CAYSTON® (aztreonam for inhalation solution) - CAYSTON.
2. Cystic Fibrosis Drugs Market and Forecast 2024-2031 - iHealthcareAnalyst.
3. Gilead's Cayston(R) Superior to Tobramycin Inhalation Solution in Six-Month Head-to-Head Cystic Fibrosis Study - Gilead Sciences.
4. AIR-CF1 Study | CAYSTON® (aztreonam for inhalation solution) - CAYSTON.