None listed
Conditions
Brief summary
In Australia Pulmozyme is licensed for use in CF with mild/moderate lung function impairment. All CF patients are eligible for an initial one-month trial, but continued funding after one month dependent on a 10% improvement in FEV1. The purpose of this one month trial of Pulmozyme is to provide information for each individual patient as to whether they benefit more with Pulmozyme before or Pulmozyme after their physiotherapy technique. Following a period of optimization of their therapy, the patients undergo 2 two-week periods: Pulmozyme given before physiotherapy, and saline nebulized after physiotherapy with the second two weeks in the reverse direction. The other half of the subjects are randomly allocated to the reverse order of interventions. Outcomes include lung function, quality of life, sputum, weight and exercise testing.
Interventions
1. Pulmozyme was given once daily via nebuliser for 2 weeks @ 2.5mg/dose
2. During days 1-14 the subjects were given one order of therapy (eg placebo saline, followed by physio then Pulmozyme) and then days 15-28 they were given the reverse order, in this case (Pulmozyme, followed by physio then placebo)
3. the federal government allows doctors to trial Pulmozyme for one month (28-30 days) as part of the PBS S100 listing. We designed the trial to keep within this requirement.
4. Physiothe
1. Pulmozyme was given once daily via nebuliser for 2 weeks @ 2.5mg/dose 2. During days 1-14 the subjects were given one order of therapy (eg placebo saline, followed by physio then Pulmozyme) and then days 15-28 they were given the reverse order, in this case (Pulmozyme, followed by physio then placebo) 3. the federal government allows doctors to trial Pulmozyme for one month (28-30 days) as part of the PBS S100 listing. We designed the trial to keep within this requirement. 4. Physiotherapy was optimised by an experienced physiotherapist before the trial. The patients performed the same physio techniques every day during the trial – by themselves, individually, at home, as per standard CF Physiotherapy used clinically– Generally it takes about 30-40 minutes, but the patient does the same thing every day before during and after the trial, with the endpoint that they have no more sputum that requires clearance techniques. This trial will directly compare Pulmozyme given before versus after physiotherapy. To maintain blinding, a matched saline nebulized therapy will be given at the other time point. The study comprises three components – baseline, first period (two weeks) followed immediately (no wash out) where two weeks of the reverse order. This duration was chosen to maintain within the Pulmozyme one month trial.
Sponsors
Jenny Bishop
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1 diagnosis of cystic fibrosis. 2 Clinically stable for one month before randomization. 3 FVC greater than 40% predicted. 4 Reproducible lung function tests. 5 Informed consent.
Exclusion criteria
1 Inability to comply with protocol 2 Lack of informed consent. 3 Clinical instability 4 Pregnancy or breast feeding. 5 Allergy or intolerance to Pulmozyme..
Outcome results
None listed