Two thousand seven is proving a very promising year for dramatic changes in COPD treatment. Not only will two new medications be made available this year, but there are many clinical trials evaluating the effectiveness of new drugs and new procedures for COPD patients.
Brovana,™ made by Sepracor, is the first available nebulized, long-acting bronchodilator, which means it opens the airways. The arformoterol tartrate solution is made into a liquid mist by a nebulizer. The mist is then inhaled to deliver medicine directly into the lungs. The delivery process takes between five and ten minutes. Brovana™ is used twice each day, once in the morning and once at night, to treat tight airways in COPD patients. The therapy has been available for prescription since April.
Additionally, Dey recently received approval on Perforomist™, which is also a nebulized, long-acting bronchodilator. The medicine is used twice daily to treat tight airways in COPD patients. The average medicine delivery time is nine minutes. The therapy will be available for prescription soon. Perforomist™ is the brand name of the chemical compound formoterol fumarate. You might be familiar with formoterol, as it has been used in dry powder inhalers under the brand name Foradil®.
As June turned to July, there were 167 COPD trials listed with ClinicalTrials.gov, the government’s website for listing and locating clinical trials. Of these trials for COPD, 142 are actively recruiting and twenty-five will soon begin recruiting. It is important to understand more about the clinical trial process. Phase I trials try to establish how much of a treatment is safe for humans. Phase II trials use larger groups to find out if the treatment works to help the disease and find side effects. Phase III trials are when a large group of study participants take an experimental treatment to ensure the treatment is safe and works well. There are currently thirty active COPD Phase III trials; this is the pivotal point that determines if a drug or therapy will meet the approval requirements of the Food and Drug Administration(FDA). Phase IV trials are conducted after a product is available to patients across the country to continue to evaluate long term safety and possible interactions with other drugs.
One promising new treatment for COPD is indacaterol, a chemical substance being studied by Novartis. Indacaterol is only one part of the Novartis three medicine plan for treating COPD, which it hopes will be the standard of care by 2011. Twenty-two single and multiple dose Phase II trials have already been completed that have shown that indacaterol works fast and lasts a full 24 hours in relieving airway tightness. Novartis is just launching its Phase III trials, the final step before submitting for FDA approval. They are recruiting 2000 patients at 200 sites in the U.S. The first six weeks of the trial will test a variety of doses and researchers will determine the two best doses after six weeks. These two doses will be compared in the remainder of the trial to establish the very best dose. The COPD Foundation is working closely with Novartis to ensure that they are able to enroll the trial as soon as possible to reduce the time COPD patients will have to wait to have access to this new treatment, provided the trial is successful.
In addition to testing new medicines, some researchers are testing new procedures for treating COPD. For individuals that have widespread COPD, the kind that can not be helped with lung volume reduction surgery, a new trial is being conducted by Broncus, a company that makes stents. The experimental procedure aims to create airway bypass structures using the same stent technology employed in cardiovascular disease for opening blocked arteries. In a patient with damaged lower airways, air can sometimes get trapped deep in the lung and cannot get out; however, using this procedure investigators think that they can create new passageways for the air to move out of the lung. The procedure involves inserting a tube down the throat, and using a needle pushed through the tube, poking tiny holes and propping them open using stents. The trial is currently seeking 400 participants at twelve sites in the United States.
If you are interested in the new medicines for COPD, but aren’t familiar with nebulizers, consider this: approximately 25% of COPD patients use nebulizers in their treatment. Talk with your doctor about Brovana™ or Perforomist™ for more information about these medications and whether or not they are a good fit for you.
It’s easy to get involved with clinical trial research to help make new therapies available for COPD patients. Simply join the COPD Foundation Research Registry by visiting our website or calling the Information Line at 1.866.316.2673. If you’re skeptical about why you might want to participate, consider this the next time you take your medicine: several hundred or several thousand people participated in a study to get that medicine approved for you to use. Perhaps you owe it to the next COPDer to help make sure they get the best medicine science can uncover.
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