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Cystic Fibrosis clinical trials

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NCT ID: NCT01889927 Completed - Cystic Fibrosis Clinical Trials

INSPIRE-CF: an Alternative Physiotherapy Model for Children With Cystic Fibrosis

INSPIRE-CF
Start date: May 1, 2012
Phase: N/A
Study type: Interventional

The primary aim of the research is to evaluate whether an alternative model of cystic fibrosis (CF) physiotherapy care can produce statistically significant improvements in clinical and patient reported outcomes, and whether this alternative model is economically advantageous and/or sustainable. Children randomised to the control group will receive 24-months of current model of CF care at Great Ormond Street Hospital (GOSH). Children randomised to the intervention group will receive 24-months of current model of CF care at GOSH PLUS a weekly structured, individually prescribed and personally supervised exercise intervention at a local fitness facility or at school. The exercise prescription will include aerobic, anaerobic, strength, core conditioning and stretching components. The main objectives of the study are: 1. Determine differences, if any, in lung function between the two groups; 2. Determine differences, if any, in exercise capacity between the two groups; 3. Evaluate cost of care of alternate model of care versus current model of care.

NCT ID: NCT01887197 Completed - Cystic Fibrosis Clinical Trials

Repeatability and Response Study of Absorptive Clearance Scans

Start date: June 2013
Phase: Phase 1
Study type: Interventional

The investigators are developing a new nuclear medicine imaging technique for measuring liquid absorption in the airways that can be applied to screen new medications being developed to treat cystic fibrosis (CF). The investigators believe that the absorption of the small molecule radiopharmaceutical Indium 111 diethylene triamine pentaacetic acid (In-DTPA) will indicate changes in liquid absorption in the airways and demonstrate whether new CF medications will be effective. In this study the investigators will determine whether the imaging technique will demonstrate similar results when it is repeated on different days. They will also determine how their results change when subjects utilize several common CF medications.

NCT ID: NCT01885650 Terminated - Cystic Fibrosis Clinical Trials

The Addition of Non-Invasive Ventilation To Airway Clearance Techniques In Adults With Cystic Fibrosis

NIV
Start date: July 2013
Phase: N/A
Study type: Interventional

Cystic Fibrosis (CF) is a genetic disorder of altered ion transport across cell membranes which is characterised by the production of thickened bodily secretions, affecting the function of organs such as the pancreas and the lungs. Within the lungs, thickened sputum is very difficult to clear, which can results in recurrent chest infections, which can lead to lung damage. therefore it is important to optimise the removal of sputum to try and prevent these complications. Traditionally, a variety of approaches are usually combined including inhaled medications to thin or hydrate secretions, and chest physiotherapy to mobilise secretions and improve sputum clearance. There are many chest physiotherapy or airway clearance techniques (ACT) available including breathing methods such as the Active Cycle of Breathing Techniques (ACBT) or Autogenic Drainage (AD) and adjuncts such as Positive Expiratory Pressure (PEP), High Frequency Chest Oscillation (the "Vest"), or oscillatory devices such as the Flutter or Acapella. When people with CF have an infection or have severe disease often the effectiveness of ACTs can decrease due to fatigue, shortness of breath or having an overwhelming amount of sputum. At this time it is necessary to re-assess ACTs and the addition of positive pressure to airway clearance techniques has been shown to be helpful in decreasing fatigue during chest physiotherapy. At present no research studies have reported an increase in sputum cleared with the addition of positive pressure, however it is thought that the ability to take a deeper breath when using positive pressure would help to improve sputum clearance. With clinical experience of the use of NIV with adult CF patients, the investigators aim to explore this objectively in this study. Research Question: Does the addition of non-invasive ventilation (Breas, I-Sleep 25) as supplementary positive pressure to normal airway clearance techniques improve sputum clearance in stable adult patients with cystic fibrosis? Hypothesis The inclusion of non-invasive ventilation in addition to a patient's normal airway clearance technique will lead to improvements in subjective ease of clearance and work of breathing during airway clearance and objectively increase sputum clearance, as well as being well tolerated in patients as an adjunct to airway clearance.

NCT ID: NCT01885169 Active, not recruiting - Cystic Fibrosis Clinical Trials

LAIV (Flumist®) Administration in CF Patients

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

Influenza (the "flu") is one of the most common respiratory viruses associated with respiratory deteriorations in children and adolescents with cystic fibrosis. These deteriorations usually mean antibiotics, hospitalizations, and worsening of pulmonary function tests. A new flu vaccine has been recently approved for use in Canada (Flumist®). What is particular about this flu vaccine is that it is a spray in the nose, which mimics how influenza usually infects us. This particular vaccine protects children and adolescents much better than the regular injectable flu shot. This new vaccine has been given to > 2,000 healthy children and to >2,000 children with asthma and well tolerated. The investigators want to know if Flumist® is well tolerated in children with CF and does not cause worsening of respiratory symptoms. The investigators will conduct a study where all participants will receive Flumist® in the nose. This study is particularly important because its results will provide safety information on a vaccine that is more efficacious for a population who needs safe and easy to administer protection against the flu.

NCT ID: NCT01883531 Completed - Cystic Fibrosis Clinical Trials

Crossover Trial Determining the Efficacy of Dry Powder Mannitol to Improve Lung Function in Subjects Aged 6-17 Years

Start date: June 2013
Phase: Phase 2
Study type: Interventional

It is hypothesised that inhaled mannitol 400 mg b.d. will lead to a significant improvement in the absolute change in percentage of predicted FEV1 from baseline following eight-weeks of trial treatment compared to treatment with inhaled placebo b.d. Any improvement in FEV1 is considered clinically meaningful; however, this trial has set a threshold of 3% for the purposes of determining an appropriate sample size for statistical power whilst retaining trial feasibility in an orphan disease population.

NCT ID: NCT01883284 Completed - Cystic Fibrosis Clinical Trials

Action of Epigenetic Modifiers in Cystic Fibrosis Treatment

Mod2EpiCF
Start date: January 2012
Phase: N/A
Study type: Interventional

Epigenetic modifiers has been showed to rescue F508del-CFTR channel to apical membrane of epithelial cell lines. In this study, the investigators evaluate epigenetic modifiers effects firstly on CFTR rescue, then on secretion and synthesis of inflammatory factors (IL-8, LXA4 and SCGB1A1) and mucines (MUC5AC and MUC5B) in a dynamic epithelium model using an air-liquide interface culture of nasals cells from CF patients or controls.

NCT ID: NCT01883037 Completed - Cystic Fibrosis Clinical Trials

Comparing Laboratory Blood Glucose Results With HemoCue Glucose 201 RT

CFRD
Start date: June 2013
Phase: N/A
Study type: Observational

There are very few studies comparing the accuracy, sensitivity and specificity of HemoCue glucose 201 RT system with the laboratory gold standard. The incidence of cystic fibrosis related diabetes (CFRD) has risen significantly as patients' survival improves. Around 30% of all cystic fibrosis (CF) adult patients have CFRD. Early diagnosis of CFRD is important to slow the deterioration of lung function and nutritional status, both of which increase mortality. The oral glucose tolerance test (OGTT) is the accepted method for detecting CFRD and the Cystic Fibrosis Trust guidelines recommend that patients with CF over the age of twelve years should be screened annually. The World Health Organisation has pointed out that due to the absence of a more specific biological marker to define diabetes, plasma glucose estimation remains the basis of diagnostic criteria. WHO recommends that venous plasma glucose should be the standard method for measuring and reporting glucose concentration in blood. However, it has also recognised that there is a widespread use of capillary sampling. Although fasting values for venous and capillary plasma glucose are the same, in the nonfasting state capillary samples will give higher results than venous samples, and glucose values require conversion which can be problematic. HemoCue Glucose 201 RT (HGS 201 RT) analyzer with plasma conversion provides laboratory quality test results at the point of care for the diagnosis, screening and monitoring of diabetes mellitus. The analyzer is easy to use and the system can be operated by nonlaboratory personnel, also the results can be presented immediately, leading to significant time and resource saving. The patient also benefits from having the result immediately instead of waiting for several hours. With immediate result, the doctor and health care professionals can provide education, support and reassurance, and implement care plans, if appropriate, at the earliest opportunity. The aim of the study is to compare the clinical accuracy of HemoCue Glucose 201 RT with the laboratory standard method in the analysis of blood glucose concentration during oral glucose tolerance test.

NCT ID: NCT01882400 Completed - Cystic Fibrosis Clinical Trials

Assessment of Response to Treatment of Osteoporosis With Oral Bisphosphonates in Patients With Muscular Dystrophy

Start date: May 2001
Phase: Phase 4
Study type: Interventional

By supplying an adequate amount of calcium and vitamin D with the addition of weekly bisphosphonate, the investigators will be able to increase bone mass and decrease the incidence of fragility fractures in these children with muscular dystrophy. The investigators think this treatment will also decrease the intensity of pain frequently present in these patients and slow the progression of scoliosis.

NCT ID: NCT01880723 Completed - Healthy Clinical Trials

Utilizing Exhaled Breathe Condensate Collection to Study Ion Regulation in Cystic Fibrosis

Start date: May 2009
Phase: N/A
Study type: Interventional

Our aims were to determine if exhaled breath condensate (EBC) could detect differences in ion regulation between cystic fibrosis (CF) and healthy and measure the effect of the albuterol on EBC ions in these populations. We hypothesized EBC chloride and sodium would be lower in CF patients at baseline and that albuterol would decrease EBC sodium and increase EBC chloride.

NCT ID: NCT01880346 Completed - Cystic Fibrosis Clinical Trials

Comparison of Absorption of Vitamin D in Cystic Fibrosis

Start date: October 2013
Phase: Phase 4
Study type: Interventional

The investigators predict that a powder pill form of vitamin D will be more effectively absorbed than an oil form of vitamin D in people diagnosed with Cystic Fibrosis.