What is Colobreathe - Colistimethate sodium?
Colobreathe is a medicine containing the active substance colistimethate sodium. It is available in capsules containing a powder for inhalation using a special device.
What is Colobreathe - Colistimethate sodium used for?
Colobreathe is indicated in the treatment of chronic lung infections caused by Pseudomonas aeruginosa bacteria in patients aged six years or older with cystic fibrosis.
Cystic fibrosis is an inherited disease that affects lung cells and intestinal and pancreatic glands that secrete fluids such as mucus and digestive juices. In cystic fibrosis these fluids become dense and viscous and cause an obstruction of the airways and the stagnation of digestive juices. The accumulation of mucus in the lungs allows the bacteria to develop more easily and causes infections, lung damage and respiratory problems. Lung infection caused by P. aeruginosa bacteria is common in patients with cystic fibrosis.
The medicine can only be obtained with a prescription.
How is Colobreathe - Colistimethate sodium used?
The contents of Colobreathe capsules are inhaled with a powder inhaler called Turbospin. The capsules cannot be used with other devices. The recommended dose is one capsule twice a day, taken as close as possible to 12 hours. The first dose at the start of treatment should be administered under medical supervision. Treatment may continue until the doctor believes that the patient benefits from it.
If the patient is being treated with other medicines for cystic fibrosis, the following order of intake should be respected: inhaled bronchodilators, chest physiotherapy, other inhaled medicines, then Colobreathe.
How does Colobreathe - Colistimethate sodium work?
The active ingredient in Colobreathe, colistimethate sodium, is an antibiotic belonging to the polymyxin group. Polymyxins act by damaging the cell membrane of bacteria thanks to the interaction with some of its components called phospholipids. Polymyxins attack a group of Gram-negative bacteria, including P. aeruginosa bacteria, because their cell membranes contain a high level of phospholipids.
Colistimethate sodium is a well-known antibiotic used for several years in the treatment of pulmonary infections in patients with cystic fibrosis, available as a solution for use with a nebulizer (a device that transforms a solution into aerosols that the patient can inhale). The use of Colobreathe, available as a powder for inhalation, should be easier for patients than for use with a nebulizer.
What studies have been conducted on Colobreathe - Colistimethate sodium?
The effects of Colobreathe were first tested in experimental models before being studied in humans.
Colobreathe was compared with another medicine, the tobramycin nebulizer solution, in 380 patients with cystic fibrosis aged six years or older with lung infection caused by P. aeruginosa. The condition of the patients had been stabilized before the study by treatment with tobramycin. The main measure of effectiveness was the improvement in FEV1, adjusted according to the age and height of the patients, after 24 weeks. The VEMS indicates the maximum volume of air that a person can breathe out in a second.
What benefit has Colobreathe shown during the studies?
Colobreathe showed similar efficacy to tobramycin treatment, considering the fact that the patients were already stabilized with a tobramycin nebulized solution. Among the patients who completed the study, the improvement in FEV1 adjusted for age and height was 0.39% with Colobreathe compared to 0.78% with tobramycin. Improvements in FEV1 observed with Colobreathe were considered sufficient to demonstrate the efficacy of the medicinal product, given that the patients who participated in the study were already stabilized with a tobramycin nebulized solution.
What is the risk associated with Colobreathe?
The most common side effects of Colobreathe seen in the studies are unpleasant taste, cough, throat irritation, difficulty in breathing and dysphonia (voice disorder). Inhalation may also cause cough or bronchospasm (contraction of the airway muscles), effects that can be mitigated by subjecting the patient to therapy with beta-2 agonists inhaled before taking the medicine. For the full list of all side effects reported with Colobreathe, see the package leaflet.
Why has Colobreathe - Colistimethate sodium been approved?
The CHMP concluded that the modest improvement in FEV1 seen with Colobreathe is sufficient proof of the efficacy of the medicinal product, considering that further improvements cannot be expected in patients whose condition is already stabilized with a tobramycin nebulised solution. Furthermore, the CHMP noted that patients generally prefer a powder to be inhaled over nebulized solutions.
The side effects seen with Colobreathe are considered acceptable. No more serious side effects were reported with Colobreathe than with tobramycin.
The CHMP decided that Colobreathe's benefits are greater than its risks and recommended that it be given marketing authorization.
What measures are being taken to ensure the safe use of Colobreathe?
The company that makes Colobreathe will provide information files to patients and healthcare professionals. The dossiers will contain information on the provisions of the treatment, instructions on how to use the medicine and information on side effects.
Other information on Colobreathe - Colistimethate sodium
On 13 February 2012, the European Commission issued a marketing authorization for Colobreathe, valid throughout the European Union.
For more information on Colobreathe therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2011.
