These clinical trails will consist of 53,000 patients for testing of the safety of a controversial class of inhaled asthma medications in which are already available for purchase. These medications are known as long-acting beta-agonists (LABAs) when used with inhaled steroids, a different class of asthma drugs, this according to the FDA as of Friday.
The medications to be studied are Symbicort by AstraZeneca, Advair Diskus by GlaxoSmithKline, Dulera by Merck & Company and Fordail by Novartis AG.
For a very long time these drugs have been under the watchful eye of the FDA as they can add to the risk of severely making asthma symptoms worse which can end up in hospitalizations and even death.
These medications work by relaxing the muscles of the airway to aide people in breathing easier and are also used as a treatment for serious lung conditions and COPD.
These studies are start later this year as the FDA is expecting results in 2017.
Among the four trails requested by the FDA, each of the LABAs along with a corticosteroid will be compared to using just a steroid . The patients will be 12 years of age and older with those studies expecting to include a total of 46,800 patients.
A few of the drugs such as Advair and Symbicort are combination drugs that do include a LABA with a corticosteroid.
The FDA is also requiring a trail consisting of 6,200 young patients age range four to eleven years old using the Advair Diskus.
According to Morning Star analyst Damien Conover these immense size trials indicates the FDA wants to be positively sure about the safety profiles of these medications which are vastly used.
A large study like this one could present several financial challenges for the manufactures of these drugs.
Lisa Behrens, spokesperson for Glaxo has commented that Glaxo is complying with the FDA request.
AstraZeneca also comments that it was finalizing the studies protocol with the FDA and supports the effort to answer any questions regarding use of its medication Symbicort.
Novartis who manufactures Fordail has stated they are reviewing the post marketing requirements given by the FDA and Merck is expected to have a comment shortly.
Just last June the FDA had issued warnings on LABAs stating these medications should never be used solely in the treatment of asthma and had called upon drug manufactures to hold further studies in order to more fully understand the safety of LABAs when used in combination with inhaled steroids.
The requirements for this massive study can be viewed on the website of the FDA, on page Drugs and Safety.
Approximately 34.1 million Americans have been diagnosed with asthma in their lifetime by a health care practitioner. Around 9 million children under the age of 18 years have been diagnosed with asthma.
With the ever growing increasing concern over asthma medications many people are turning to alternative therapies to aide in control of their asthma among them is many parents who children have asthma and do not wish to have their child exposed to the medications which carry numerous side effects among them making asthma symptoms worse.
A few noted alternative treatments include:
Several studies have been conducted using chiropractic care and the treatment of asthma. In one trial conducted in Australia involving 420 patients average adult age of 46.
Dr. Ray Hayek who had conducted the trial had reported that the group of patients who had undergone chiropractic spinal manipulations had shown significant improvement in asthma symptoms. Regular chiropractic adjustments have also been demonstrated to improve children’s asthmatic symptoms which have included higher quality of life and less severe attacks.
Shonihari an acupuncture treatment is used to treat asthma in children. Mainly due to the fact it is needle free, adults may also use this treatment. This treatment involves several metal implements in which gently stimulates the meridians and acupuncture points to move the qi where it is blocked and strengthens it where it has become weak.
Station 1450 WHTC
American Academy of Allergy, Asthma & Immunology
Center for Integrative Health and Healing