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Cystic Fibrosis clinical trials

View clinical trials related to Cystic Fibrosis.

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NCT ID: NCT00449904 Completed - Cystic Fibrosis Clinical Trials

Open-Label Phase III Long-Term Safety Trial of Liprotamase

DIGEST
Start date: June 2007
Phase: Phase 3
Study type: Interventional

This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in patients with cystic fibrosis (CF)-related exocrine pancreatic insufficiency (PI).

NCT ID: NCT00449878 Completed - Cystic Fibrosis Clinical Trials

Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

DIGEST
Start date: May 2007
Phase: Phase 3
Study type: Interventional

This is a clinical trial which will evaluate the efficacy of Liprotamase treatment in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (PI).

NCT ID: NCT00446680 Completed - Cystic Fibrosis Clinical Trials

Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study

Start date: March 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of chronic treatment with inhaled dry powder mannitol in subjects with cystic fibrosis. Previous studies have demonstrated an improvement in lung function related to small airways obstruction and a significant improvement in respiratory symptoms and quality of life after a 2 week treatment with mannitol. This current study seeks to support these early findings and to extend the evidence to support its use as a mucoactive therapy in cystic fibrosis. In particular, the hypothesis that enhanced mucus clearance will improve the lung function and clinical presentation in this population, will be investigated. We also hypothesize that enhanced mucociliary clearance will result in a sustained reduction in mucus load, thus providing less opportunity for bacteria to proliferate, affording a reduction in antibiotic use and hospitalizations. The initial 6 month blinded phase will be followed with an additional 6 months of open label treatment.

NCT ID: NCT00434278 Terminated - Cystic Fibrosis Clinical Trials

A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)

Start date: March 2007
Phase: Phase 4
Study type: Interventional

This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme. Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks (placebo group). Patients must have had stable CF symptoms without any change in therapy for 2 weeks prior to enrollment in order to participate.

NCT ID: NCT00432861 Completed - Cystic Fibrosis Clinical Trials

Evaluation of the Safety and Efficacy of Pancrecarb® MS-16 in Cystic Fibrosis

Start date: January 2007
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine if PANCRECARB® MS-16 (pancrelipase) is safe and effective in reducing steatorrhea (as measured by 72-hour stool fat determinations) in children and adults with cystic fibrosis and pancreatic insufficiency.

NCT ID: NCT00431964 Completed - Cystic Fibrosis Clinical Trials

Effect of Azithromycin on Lung Function in 6-18 Year-olds With Cystic Fibrosis (CF) Not Infected With P. Aeruginosa

Start date: February 2007
Phase: Phase 4
Study type: Interventional

This is a study to examine the safety, effect on lung function, and frequency of symptoms relating to cystic fibrosis during 24 weeks of treatment with the antibiotic azithromycin in 6-18 year-olds with CF who are not infected with Pseudomonas aeruginosa.

NCT ID: NCT00425165 Terminated - Cystic Fibrosis Clinical Trials

Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease

Start date: August 2007
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to evaluate the effects of a single dose of denufosol versus placebo on mucociliary clearance in patients with mild to moderate CF lung disease

NCT ID: NCT00420836 Completed - Cystic Fibrosis Clinical Trials

Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

Start date: April 2006
Phase: Phase 1
Study type: Interventional

This study assesses the aerosol delivery characteristics (measured by nebulization time, serum and sputum tobramycin pharmacokinetic parameters) and safety of tobramycin administered for inhalation by PARI eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet Nebulizer (with compressor) in subjects with cystic fibrosis.

NCT ID: NCT00418470 Terminated - Cystic Fibrosis Clinical Trials

Prolonging the Duration of Peripheral Venous Catheters in Cystic Fibrosis People

Start date: March 2007
Phase: Phase 4
Study type: Interventional

Patients with cystic fibrosis (CF) need to frequently undergo courses of IV antibiotic therapy. To avoid a high number of venipunctures peripheral venous catheters (SPVC) or cannulas are used. Because of the irritant action of the drugs used, SPVC's often do not last for the whole antibiotic course (usually of two weeks) and the patient has to be punctured again for the insertion of a new IV line. With the passing of time the veins are more difficult to be found. An alternative to the use of a cannulas is the surgical insertion of a central venous catheter. This intervention may have contraindications or, specially in adolescents, cause unacceptable alterations of the body image. The aim of this study is to find a way to prolong the duration of the SPVC used by CF patients during antibiotic courses avoiding the irritation of the vein or a phlebitis. Design of the study: randomized controlled trial. The study will see a collaboration of nurses, physicians and technicians of the Tuscan CF Centre. The patients that will participate at the study will be randomly assigned to one of the two groups: one group will receive the antibiotics prescribed according to the maximal dilution suggested by the pharmaceutical company, the other will receive a much higher dilution (i.e. a higher volume of Normal Saline), but the time of administration will be the same. The assessment will regard: the level of inflammation of the vein (with a special visual scale) and the duration of the SPVC. The hypothesis that is to be proved is that diluting the antibiotic in a higher volume of Normal Saline it is possible to delay or prevent the irritation of the vein and the onset of a phlebitis. In case that the hypothesis will be confirmed by this study an easy, secure, low cost and immediately available system will be available to reduce the number of venipunctures necessary to complete a course of IV antibiotics.

NCT ID: NCT00416182 Completed - Cystic Fibrosis Clinical Trials

Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

Start date: December 2006
Phase: Phase 2
Study type: Interventional

Chronic sinusitis is a frequent complication in cystic fibrosis. The aim of this study is to determine whether Pulmozyme(dornase alfa) would maintain sinus health (compared to placebo) in patients with cystic fibrosis who have recently undergone sinus surgery.