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Cystic Fibrosis clinical trials

View clinical trials related to Cystic Fibrosis.

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NCT ID: NCT02038803 Completed - Cystic Fibrosis Clinical Trials

Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution

PETIS
Start date: October 2013
Phase:
Study type: Observational

Inhaled tobramycin is a Cystic Fibrosis Foundation recommended effective treatment for individuals with cystic fibrosis for the management of Pseudomonas aeruginosa airway colonization and improves the FEV1 and reduces the number of acute pulmonary exacerbations of CF. Patients typically use the inhaled tobramycin for a period of 28 days. Unfortunately, the standard nebulizer method for delivering tobramycin inhaled solution (TIS) is time-consuming and may result in missed therapy doses and suboptimal care. A new inhaled formulation and delivery device, the TOBI Podhaler (TPI), is a quicker, more efficient method of administering inhaled Tobramycin. This new pocket-sized disposable inhaler is maintenance free, requires no refrigeration or power source, and should greatly increase patient mobility and improve time management.

NCT ID: NCT02036879 Completed - Clinical trials for Cystic Fibrosis (CF)

Gender Disparity and Hormones in Cystic Fibrosis

Start date: February 2014
Phase: Early Phase 1
Study type: Interventional

The objective of this study is to investigate the impact of hormones on lung disease in Cystic Fibrosis (CF) patients. Due to improved therapies, CF patients are living longer and healthier lives than they did 20 years ago. However, females have been shown to have a survival disadvantage. The median life expectancy is 33 in women and 37 in men with CF. The hypothesis is that estrogen and/or progesterone negatively impact lung health in CF. Therefore, understanding the impact of sex hormones (including the use of birth control pills) on the disease process is increasingly important. The purpose of this study is to determine if lung function, respiratory symptoms, or various markers of lung health change during different phases of the natural ovulatory cycle in order to understand if estrogen or progesterone hormones are impacting the disease relative to fluctuations in men with stable testosterone levels. The research objectives of this project are to: - Determine if lung function, respiratory symptoms, or various markers of lung health change during different hormonal phases of the ovulatory cycle in women. - Determine if men change lung function, respiratory symptoms, or various markers of lung health over time. - Determine if oral contraceptive pills in women stabilize fluctuations in symptoms and improve lung health.

NCT ID: NCT02029521 Completed - Cystic Fibrosis Clinical Trials

Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis Patients

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

Many individuals with cystic fibrosis experience growth failure. The reasons are not clear, but inflammation of the gut in these patients seems to be one important reason. Glutathione is important to normal function of the intestine and lungs. Glutathione functions to decrease inflammation and to thin mucus. However, in cystic fibrosis, glutathione gets trapped inside of cells, so it cannot travel to the surface of the cells and perform its proper function. Moreover, glutathione has been shown to improve nutritional status in patients with AIDS and cancer. Investigators hypothesize that supplementation of oral glutathione to pediatric individuals with cystic fibrosis could improve growth failure.

NCT ID: NCT02025829 Completed - Cystic Fibrosis Clinical Trials

IL-17 Neutrophils in CF Lung Inflammation

Start date: February 2014
Phase:
Study type: Observational

The purpose of this study is to determine whether IL-17 polymorphonuclear leukocytes (PMNs) are central to the disease pathology in CF. This will be determined by demonstrating that IL-17 PMNs are present in the CF airway, correlate with lung function measures, and decrease in patients being treated with IV antibiotics for a pulmonary exacerbation.

NCT ID: NCT02015507 Completed - Cystic Fibrosis Clinical Trials

An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on Ivacaftor and VX-661 in Combination With Ivacaftor

Start date: January 2014
Phase: Phase 1
Study type: Interventional

To evaluate the effect of ciprofloxacin on the pharmacokinetics (PK) of ivacaftor and on the pharmacokinetics of VX-661 when administered in combination with ivacaftor

NCT ID: NCT02014181 Completed - Cystic Fibrosis Clinical Trials

Flaxseed Modulates Inflammation and Oxidative Stress in CF

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

Flaxseed (FS) is a safe and well tolerated supplement with an ability to fight inflammation and oxidative stress - a byproduct of daily stress the human body faces everyday and especially with chronic diseases. Cystic fibrosis (CF) is a genetic disease resulting from a mutation in sodium and chloride transport channels that results in pancreatic insufficiency, chronic sinusitis and chronic lung infections. The investigators hypothesize that chronic inflammation and oxidative stress are a part of the chronic exacerbations that are a part of cystic fibrosis. The investigators believe that flaxseed with its anti-inflammatory and antioxidative properties can help dampen these stressors on the CF lung and potentially result in fewer exacerbations of CF, fewer antibiotics, fewer hospitalizations, and improved well-being.

NCT ID: NCT02003079 Completed - Cystic Fibrosis Clinical Trials

Evaluating the Impact of Chronic Rhinosinusitis on the Health-Related Quality of Life Among Adults With Cystic Fibrosis

Start date: September 2013
Phase: N/A
Study type: Observational

Individuals with Cystic Fibrosis (CF) have a defective protein, which is known as the cystic-fibrosis transmembrane regulator (CFTR). The CFTR transports salt and hydrates mucous. CFTR defects may result in the accumulation of thick mucous in the sinus cavities. As a result, the tiny hair-like structures that sweep mucous out of the sinuses cannot function properly, which can lead to recurrent infection and swelling of the sinus walls. When symptoms are persistent for more than 12 weeks, this is known as chronic rhinosinusitis (CRS). The symptoms that are associated with CRS are nasal discharge, congestion, facial pain or pressure and reduced sense of smell. CRS in non-CF patients affects a large number of individuals in Canada and has been found to be associated with poor quality of life. In the CF population the life expectancy is increasing but chronic disease like CRS is becoming increasingly prevalent. Investigators currently do not know the impact that CRS has on the health-related quality of life in adults with CF and how many suffer from symptoms. The investigators aim to determine the impact of CRS among adults with CF, in order to gain a better understanding of chronic disease among these individuals. The investigators strongly feel this research will improve the referral processes between Respirologists and Otolaryngologists, thereby improving treatment and quality of life for patients.

NCT ID: NCT01991028 Completed - Cystic Fibrosis Clinical Trials

A Study to Investigate Lung Deposition of Radiolabelled OligoG

Start date: April 2014
Phase: Phase 2
Study type: Interventional

OligoG is a new potential treatment which is being developed by AlgiPharma AS (a Norwegian-based company) with an aim to help people with cystic fibrosis in the future. OligoG, derived from marine algae, is expected to act locally in the lungs once inhaled to reduce mucus thickness and improve mucus clearance. It could also have the benefit of reducing the incidence of infections. Nebulised doses of up to 540 mg/day have been administered to healthy volunteers for three consecutive days and to cystic fibrosis patients for 28 consecutive days. Both groups tolerated the medication well, with no treatment related issues reported. The dose administered in this study is lower; patients who complete the study will receive, in total, 186 mg of OligoG in two divided doses. A new dry powder formulation of OligoG has been developed so that patients can use an inhaler, rather than a nebuliser. Administration from an inhaler compared to a nebuliser is much quicker and more practical for the patient. In this study, we will use gamma scintigraphy to see where in the lungs the dry powder and nebulised solution go after being inhaled by cystic fibrosis patients. Gamma scintigraphy is a well-established medical imaging technique. A small amount of radioactive material will be added to both the dry powder and nebulised solution. The radiation emitted will then be detected by taking images using a device known as a gamma camera. The procedure is relatively easy and non-invasive. The purpose of this study is to help answer the following research questions: - How do the OligoG dry powder and nebulised solution distribute in the lungs of patients with cystic fibrosis? - How much of the formulation gets to the deep lung? - How much of the formulation remains in the devices used for administration?

NCT ID: NCT01987271 Completed - Cystic Fibrosis Clinical Trials

Effects Of Noninvasive Ventilation On Functional Capacity Of Patients With Cystic Fibrosis

Start date: August 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effect of noninvasive ventilation (NIV) in functional capacity of children and adolescents with cystic fibrosis.

NCT ID: NCT01983787 Completed - Cystic Fibrosis Clinical Trials

Pharmacokinetics of Piperacillin, Given as Continuous Infusion to Patients With Cystic Fibrosis

Start date: July 2013
Phase: Phase 4
Study type: Observational

At the Department of Infectious Diseases, Aarhus University Hospital, continuous infusion with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in patients with cystic fibrosis, suffering from acute pulmonary exacerbations (APE). It is an outpatient treatment. To assess the efficacy and quality of the treatment, a blood test every 3rd day is taken to determine the concentration of Piperacillin in blood-plasma.