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Cystic Fibrosis clinical trials

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NCT ID: NCT01116089 Completed - Cystic Fibrosis Clinical Trials

Pharmacokinetic Study of Bramitob® Administered for Inhalation by PARI eFlow® vs PARI LC® PLUS Nebulizer

Start date: July 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess pharmacokinetic and safety comparability of Bramitob® when administered for inhalation by using PARI eFlow® rapid electronic nebulizer vs PARI LC® PLUS nebulizer in Cystic Fibrosis Patients infected with Pseudomonas Aeruginosa

NCT ID: NCT01112059 Completed - Cystic Fibrosis Clinical Trials

Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients

DOXY
Start date: November 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the role of a well-known and well-tolerated antibiotic, doxycycline, in the treatment of cystic fibrosis patients who are hospitalized. This antibiotic does not effectively treat the bacteria in airways of cystic fibrosis patients, but may reduce the activity of inflammatory molecules in the disease.

NCT ID: NCT01111383 Completed - Cystic Fibrosis Clinical Trials

A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®

CT03Ext
Start date: September 2009
Phase: Phase 3
Study type: Interventional

This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if deemed appropriate by the Investigators will be able to be included in the 48-week follow-on period (Extension Study) to continue the treatment only with Bramitob® (tobramycin nebuliser solution, 300 mg twice daily in 4 mL unit dose vials).

NCT ID: NCT01104402 Completed - Cystic Fibrosis Clinical Trials

Early Intervention in Cystic Fibrosis Exacerbation

eICE
Start date: October 2011
Phase: N/A
Study type: Interventional

Individuals with cystic fibrosis (CF) develop chronic lung infections and suffer intermittent acute exacerbations of their lung disease. Most exacerbations are not treated until they cause increased symptoms, and patients seek medical attention. This proposal details a study of home lung function and symptom monitoring. Subjects will be randomly assigned to one of two groups: 1) home monitoring, in which spirometry and symptoms are recorded; or 2) standard care. The home monitoring data will be transmitted electronically to the study center. If spirometry or symptoms have deteriorated substantially, treatment for a CF pulmonary exacerbation will be initiated. It is anticipated that use of home monitoring will lead to earlier, more reliable recognition and treatment of exacerbations, which will translate into better lung health.

NCT ID: NCT01100892 Completed - Diabetes Clinical Trials

Cystic Fibrosis - Insulin Deficiency, Early Action

CF-IDEA
Start date: December 2010
Phase: Phase 3
Study type: Interventional

Cystic Fibrosis (CF) is the most common life-threatening genetic condition affecting Australian children. As well as repeated lung infections, children with CF develop insulin deficiency and eventually diabetes. The CF-IDEA trial (Cystic Fibrosis - Insulin Deficiency, Early Action) will determine whether starting insulin treatment before the onset of diabetes (earlier than current practice) will improve the health of children with CF by improving body weight and lung function.

NCT ID: NCT01100606 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age

Start date: June 2010
Phase: Phase 4
Study type: Interventional

A study to determine the safety, effectiveness, and acceptability of 2 methods of administration of EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) 3,000 lipase units capsule, a pancreatic enzyme product (PEP), in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). This study is sponsored by Aptalis Pharma (formerly Eurand).

NCT ID: NCT01094704 Completed - Cystic Fibrosis Clinical Trials

Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis

Start date: November 2009
Phase: Phase 1
Study type: Interventional

Direct measurement of mucociliary and cough clearance (MCC/CC) has been used as a biomarker in cystic fibrosis (CF). Additional knowledge of the performance of this biomarker is needed to inform exploratory clinical trial design in support of programs to develop new inhaled therapies for CF. We hypothesize that MCC/CC measurements can be used to determine the durability of action of agents like hypertonic saline (HS) which increase epithelial lining fluid height.

NCT ID: NCT01093521 Completed - Cystic Fibrosis Clinical Trials

A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients

Start date: April 2010
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to test the pharmacokinetics, safety, and tolerability of an intravenous infusion of a drug called Ganite (gallium nitrate) in patients with cystic fibrosis. We want to see this drug is safe and tolerable and to see if high levels of the drug are found in the sputum. Funding Source - Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD)

NCT ID: NCT01091025 Completed - Clinical trials for Screening of Cystic Fibrosis Related Diabetes

Comparing Two Different Approaches in the Screening of Cystic Fibrosis Related Diabetes

CFRD
Start date: March 2009
Phase: N/A
Study type: Interventional

The incidence of cystic fibrosis related diabetes (CFRD) has risen significantly as patients' survival improves. Early diagnosis of CFRD is crucial to prevent the unnecessary deterioration of lung function and nutritional status, both of which affect the patient's overall survival. The oral glucose tolerance test (OGGT) is the accepted method for detecting CFRD. The Cystic Fibrosis Trust guidelines (2004) recommend that patients with CF over the age of twelve years should be screened annually. Most hospitals use an annual OGTT. Performing OGTT on all CF patients is inconvenient and may not be cost effective, as patients have to starve overnight and need to spend an extra 2 hours in the hospital in addition to all the other annual review tests. In our centre, a selective approach is used. If patients have an abnormal random blood glucose and /or abnormal glycosylated haemoglobin (HbA1c) and/or symptoms of hyperglycaemia or unexplained weight loss then an OGTT will be performed. The aims of this study are 1. To compare the clinical efficiency in the screening for CFRD in the two different methods: i)a selective approach , ii)an unselected annual OGTT for all patients. 2. To compare the cost effectiveness of the two approaches in the screening for CFRD.

NCT ID: NCT01086839 Completed - Cystic Fibrosis Clinical Trials

Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

Start date: March 2010
Phase: N/A
Study type: Interventional

Rhinosinusitis disorders are almost regularly associated to Cystic Fibrosis (CF). The basic defect in CF is a dysfunction of chloride channels in exocrine glands which equally concerns upper airway mucosa. It leads to retention of secretions and consecutive chronic inflammation with bacterial superinfection. In CF rhinosinusitis can restrict quality of life, give cause to repeated ear, nose, and throat (ENT) surgery and accelerate disease progression by bacterial acquisition into the airways. The multicenter, randomized, double-blind, placebo-controlled, prospective clinical trial aims at the evaluation of a sino-nasal inhalation of sodium chloride 6% compared to isotonic saline with respect to ENT-related quality of life which is influenced by mucus retention and the resulting inflammation.