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Fibrosis clinical trials

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NCT ID: NCT01509339 Withdrawn - Cystic Fibrosis Clinical Trials

Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis

Start date: January 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the pharmacokinetics and safety of inhaled vancomycin in patients with cystic fibrosis.

NCT ID: NCT01460849 Withdrawn - Cystic Fibrosis Clinical Trials

Assess Increased Mortality Risk With Each Year of Delayed Tobramycin Solution (TIS) Initiation, and Effect of TIS on Mortality Across Study Centers

Start date: March 2011
Phase:
Study type: Observational

Using CFF registry data, this analysis will: describe patterns of time to TIS initiation from first year of TIS eligibility, estimate the increased risk of death attributable to each year of delayed TIS initiation, and investigate TIS effects across study centers.

NCT ID: NCT01346930 Withdrawn - Clinical trials for Idiopathic Pulmonary Fibrosis

Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis

MUSIC OL
Start date: July 2011
Phase: Phase 2
Study type: Interventional

The MUSIC OL study is an open-label extension study, in which all eligible patients having completed the double-blind AC-055B201/MUSIC study as scheduled receive macitentan 10 mg once daily. The study objective is to assess the long-term safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis (IPF).

NCT ID: NCT01315691 Withdrawn - Cystic Fibrosis Clinical Trials

Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas Aeruginosa

Start date: n/a
Phase: Phase 3
Study type: Interventional

A major factor in the respiratory health of Cystic Fibrosis (CF) subjects is the prevalence of chronic Pseudomonas aeruginosa infections. The Pseudomonas aeruginosa infection rate in CF patients increases with age and by age 18 years approximately 85% of CF patients in the US are infected. Liposomal amikacin for inhalation (Arikace™) was developed as a possible treatment for chronic infection due to Pseudomonas aeruginosa in CF patients. The purpose of this double-blind, placebo controlled study is to determine whether Arikace™ is effective in treating chronic lung infections caused by Pseudomonas aeruginosa in Cystic Fibrosis subjects. The study will enroll approximately 300 subjects in clinics in the US, Canada, Europe, Australia and New Zealand. Subjects will be randomized to 590 mg Arikace™ or placebo and will receive treatment for 28 days followed by a 56 day safety follow-up period. The subjects will be required to visit the clinic 8 times (including the Screening visit) over a period of approximately 3 months. No overnight stays at the clinic will be required. At the completion of the TR02-109 protocol, subjects who have consented and meet study safety criteria may enroll in the long-term, open-label, multi-cycle extension study of 590 mg of Arikace™ (under a separate protocol TR02-110).

NCT ID: NCT01233674 Withdrawn - Fibrosis Clinical Trials

Examination of Left Atrial Fibrosis Using MRI

Start date: March 2011
Phase:
Study type: Observational

This study evaluates images obtained from a standard clinical cardiac MRI for evidence of fibrosis.

NCT ID: NCT01229553 Withdrawn - Cystic Fibrosis Clinical Trials

Effect of Topical and Systemic Decolonization of Staphylococcus Aureus (SA) in Pediatric Cystic Fibrosis (CF) Patients

Start date: January 2011
Phase: N/A
Study type: Interventional

The primary objective of this study is to measure efficacy of our new protocol by monitoring the results of our routine respiratory cultures at the end of the new standard treatment, and during routine visits for 1 year from initiation of therapy for Staphylococcus aureus. The secondary objective will include determining the clinical course (pulmonary exacerbations, antibiotic use, hospitalizations, pulmonary function tests) of patients who underwent the protocol.

NCT ID: NCT01194232 Withdrawn - Lung Perfusion Clinical Trials

Sildenafil Trial in Children and Young Adults With CF

Start date: August 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Cystic Fibrosis (CF), the most common inherited disease in Caucasians, is characterized by chronic pulmonary inflammation and progressive loss of gas exchange units that eventually results in respiratory failure. There is strong evidence that, in CF, abnormally low perfusion carries a high risk of death independent from the presence of pulmonary hypertension. However, the evolution of pulmonary vascular disease in CF and how it might contribute to the rate of decline in lung function is not known. Our knowledge remains limited to the results of old observational studies which concluded that the major causes of pulmonary vascular remodeling and hypertension in CF are hypoxic respiratory failure and destruction of lung tissue. Our recent data obtained by state-of-the-art Magnetic Resonance Imaging (MRI) of the pulmonary circulation, challenges the existing paradigm. We demonstrate that in the absence of hypoxia, significant changes in pulmonary perfusion and in surrogate measures of vascular resistance as well as in collateral blood flow begin early in the course of CF. Newly developed therapeutics have altered dramatically the course of patients suffering from pulmonary vascular disease. Through this 8 week trial, we will examine by Magnetic Resonance Imaging the effect of Sildenafil on pulmonary perfusion and systemic vascularization of the lungs in subjects with mild to moderate disease.

NCT ID: NCT01155752 Withdrawn - Cystic Fibrosis Clinical Trials

Pulmozyme in Cystic Fibrosis With Sinusitis

Start date: July 2013
Phase: Phase 3
Study type: Interventional

The hypothesis is that the intranasal use of Pulmozyme will decrease the severity of sinusitis in Cystic Fibrosis and lead to an improved quality of life.

NCT ID: NCT01135199 Withdrawn - Pulmonary Fibrosis Clinical Trials

Pomalidomide for Cough in Patients With Idiopathic Pulmonary Fibrosis

Start date: April 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of pomalidomide over a 12 week duration in the treatment of chronic cough in patients with IPF as measured by a Cough Symptom Diary, Visual Analogue Scale for Cough Severity, Leicester Cough Questionnaire, St. George Respiratory Questionnaire, Cough-Specific Quality-of-Life Questionnaire, and adverse event reporting. There will be an option open to participants, who respond to treatment by meeting pre-determined criteria, to remain in the study for an additional 9 months or for a total of 54 weeks.

NCT ID: NCT01092572 Withdrawn - Cystic Fibrosis Clinical Trials

Statins To Treat Adult Cystic Fibrosis

CFStatin
Start date: May 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Cystic fibrosis (CF) is a lethal genetic condition that affects 30,000 children and adults in the United States. Although CF management has improved substantially over the past two decades, there is still no cure and most patients with CF die before reaching their 50th birthday, largely due to lung failure. There is growing evidence that excess lung and blood inflammation that occurs in response to infections in the lungs cause CF patients to be sicker. Simvastatin is a drug that is used to lower cholesterol, but many researchers have found that this drug may also treat blood and lung inflammation. In this study, we will determine whether or not simvastatin can treat blood and lung inflammation in patients with CF and most importantly determine whether or not it can make these patients feel better and have better lung function.