PULMOZYME SUMMARY
Pulmozyme is a sterile, clear, colorless, highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. The protein is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing DNA encoding for the native human protein, deoxyribonuclease I (DNase). Fermentation is carried out in a nutrient medium containing the antibiotic gentamicin, 100-200 mg/L. However, the presence of the antibiotic is not detectable in the final product. The product is purified by tangential flow filtration and column chromatography. The purified glycoprotein contains 260 amino acids with an approximate molecular weight of 37,000 daltons (1). The primary amino acid sequence is identical to that of the native human enzyme.
Pulmozyme is administered by inhalation of an aerosol mist produced by a compressed air driven nebulizer system (see Clinical Experience, DOSAGE AND ADMINISTRATION). Each Pulmozyme single-use ampule will deliver 2.5 mL of the solution to the nebulizer bowl. The aqueous solution contains 1.0 mg/mL dornase alfa, 0.15 mg/mL calcium chloride dihydrate and 8.77 mg/mL sodium chloride. The solution contains no preservative. The nominal pH of the solution is 6.3.
Daily administration of Pulmozyme® (dornase alfa) Inhalation Solution in conjunction with standard therapies is indicated in the management of cystic fibrosis patients to improve pulmonary function. In patients with an FVC >=40% of predicted, daily administration of Pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics.
Safety and efficacy of daily administration have not been demonstrated in patients for longer than twelve months.
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NEWS HIGHLIGHTS
Published Studies Related to Pulmozyme (Dornase Alfa)
Inhaled Dornase alfa (Pulmozyme) as a noninvasive treatment of atelectasis in
mechanically ventilated patients. [2013]
and time intensive and not highly effective... CONCLUSIONS: Dornase alfa does not improve the appearance of atelectasis on chest
Dornase alfa reduces air trapping in children with mild cystic fibrosis lung
disease: a quantitative analysis. [2005]
from spirometry or visually scored high-resolution CT (HRCT) scans of the chest... CONCLUSIONS: Quantitative air trapping is a more consistent sensitive outcome
A two-year randomized, placebo-controlled trial of dornase alfa in young patients
with cystic fibrosis with mild lung function abnormalities. [2001]
reduces respiratory tract exacerbations... CONCLUSIONS: Treatment of young patients with CF with dornase alfa maintains lung
Effects of 12-week administration of dornase alfa in patients with advanced
cystic fibrosis lung disease. Pulmozyme Study Group. [1996]
fibrosis (CF) with advanced lung disease... CONCLUSIONS: Pulmonary function as measured by FEV1 and FVC improved
Effect of aerosolized recombinant human DNase on exacerbations of respiratory
symptoms and on pulmonary function in patients with cystic fibrosis. The
Pulmozyme Study Group. [1994]
(rhDNase), a bioengineered copy of the human enzyme... CONCLUSIONS: In patients with cystic fibrosis, the administration of rhDNase
Clinical Trials Related to Pulmozyme (Dornase Alfa)
Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis [Completed]
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.
Impact of Nebulized Dornase Alpha on Mechanically Ventilated Patients [Completed]
The investigators hypothesized that dornase alpha, administered twice a day (BID) by in-line
nebulizer, would improve oxygenation, compliance, and time to extubation in adult patients
receiving mechanical ventilation.
A Study of Pulmozyme� (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis [Terminated]
This was a Phase IV, multicenter, randomized, double-blind, placebo-controlled trial
designed to evaluate the effect of Pulmozyme on pulmonary function, health-related quality
of life (HRQOL), and respiratory symptoms in 3- to 5-year-old children with cystic fibrosis
(CF). Approximately 40 patients were planned to be enrolled in this study. However, only 3
patients were eligible for random allocation and received treatment: 1 patient in the
Pulmozyme group and 2 patients in the placebo group. All 3 patients completed the study
assessments but did not have usable pulmonary function test (PFT) data.
Effectiveness of Pulmozyme in Infants With Cystic Fibrosis [Active, not recruiting]
This is a study to find out whether Pulmozyme is effective for clearing mucus from the
airways of children with cystic fibrosis less than 3 ½ years of age. Pulmozyme is given
using a nebulizer and is now widely used in older children and adults with cystic fibrosis.
In adults and older children, studies have shown that daily use of Pulmozyme improves lung
function and decreases the number of lung infections requiring hospital treatment. Pulmozyme
has been approved by the Food and Drug Administration for use in children over 5 years old
and adults with cystic fibrosis. Pulmozyme has also been approved by the FDA for use in
children with cystic fibrosis less than 5 years old based upon studies showing that it is
safe in this age group and that it does get into the airway tubes as well in infants and
toddlers as it does in older children and adults. Currently Pulmozyme is not widely used in
children with cystic fibrosis younger than 5 years because no study has clearly shown that
inhaling Pulmozyme daily improves lung function or improves clearance of mucus from the
airway tubes in very young children. This study will measure whether Pulmozyme improves lung
function and mucous clearance from the lungs in children with cystic fibrosis less than 3 ½
years of age.
This study will compare Pulmozyme to a placebo. During the study infants and young children
with cystic fibrosis will be treated with Pulmozyme for 6 months and placebo for 6 months.
The study medicines will be inhaled at home once a day from a nebulizer for a period of one
year. Half of the children will be treated with Pulmozyme for the first 6 months of the
study and half will receive the placebo. At the 6 month point the group receiving Pulmozyme
will be changed to the placebo and the group receiving placebo will be changed to Pulmozyme.
The order of the 6 month treatment periods is randomized. This study is blinded. The study
doctor and his staff will not know who is receiving Pulmozyme or placebo at any time during
the study.
Whether Pulmozyme works will be measured using infant lung function tests and by doing a
special 3-D x-ray of the child's chest (a high resolution CT or HRCT) at the beginning of
the study, at 6 months and at 12 month after starting study. The study will not change the
regular clinical care.
Pulmozyme for Sjogren's Associated Cough [Withdrawn]
Patients with Sjogren's disease have destruction of the mucus secreting cells in the airway.
This manifestation of the disease leads to the common complaint of persistent dry cough that
is seen in many of these patients. This study is aimed at determining whether the regular
use of Pulmozyme will result in decreased cough and improved quality of life.
Reports of Suspected Pulmozyme (Dornase Alfa) Side Effects
Death (18),
Pneumonia (8),
Pyrexia (3),
Haemoptysis (3),
Drug Ineffective (2),
Lung Infection (2),
Cough (2),
Cystic Fibrosis (2),
Asthma (1),
Blood Creatine Phosphokinase Increased (1), more >>
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Page last updated: 2014-12-01
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