COPD

COPD Treatments: Chlorofluorocarbon Inhalers Are OUT!

COPD Treatments: Chlorofluorocarbon Inhalers Are OUT!

COPD Treatments: Chlorofluorocarbon Inhalers Are OUT!

 

COPD Treatments: Chlorofluorocarbon Inhalers Are OUT!

 

NBN Infusions delivers comprehensive services to patients of all ages, from pediatric to geriatric, providing a full range of care for Home Infusion Therapy. NBN Infusions on-site, licensed pharmacy can provide prescription medications, equipment, supplies and skilled nursing care needed for Home Infusion Therapy.

Home Infusion Therapy is a more convenient and cost-effective option than traditional inpatient therapy, with care administered in the comfortable surroundings of one’s own home. Home Infusion Therapy allows for a more active role in one’s own health care. It can also ease stress and anxiety that is sometimes associated with inpatient treatment, resulting in better patient outcomes.

 

The U.S. Food and Drug Administration will complete its phase-out of all inhaler medical products containing chlorofluorocarbons (CFCs) by Dec. 31, 2013. This effort is to comply with an international treaty to protect the ozone layer by phasing out the worldwide production of numerous substances, including CFCs, which contribute to ozone depletion.

 

While most inhaler products containing CFCs have already been phased out by the FDA, two products currently remain on the market: Combivent Inhalation Aerosol and Maxair Autohaler. However, these products will no longer be available after the end of this year. People with asthma or chronic obstructive pulmonary disease (COPD) who use these inhalers should talk to their health care professional about a prescription for an alternative treatment.

 

Inhalers are critical products for those persons suffering from asthma or COPD. In the United States, more than 25 million people suffer from asthma, a disease that affects the airways in the lungs and can cause coughing, trouble breathing, wheezing and tightness or pain in the chest. Additionally, 15 million people have been diagnosed with COPD, a serious lung disease that worsens over time. Symptoms can include chest tightness, chronic cough and excessive phlegm.

 

“CFCs were used as propellants to move the drug out of inhalers so that patients can inhale the medicine,” said Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “For more than two decades, the FDA and EPA have collaborated to phase-out CFCs in inhalers – a process that included input from the public, advisory committees, manufacturers, and stakeholders.”

 

Most inhalers that used CFCs have already been phased out by the FDA. The inhaler that was most widely used—albuterol CFC inhaler—was phased out in 2008 and replaced with inhalers that use propellants called hydrofluoroalkanes (HFAs). There are many safe and effective inhalers available to treat asthma and COPD symptoms. All of these inhalers require a prescription, which must come from a licensed health care professional (a physician, physician’s assistant or nurse practitioner).

 

“The EPA and FDA’s partnership has facilitated a safe, gradual transition to CFC-free inhalers in the United States,” said Drusilla Hufford, director of EPA’s Stratospheric Protection Division of the Office of Air and Radiation. “This action is an important contribution to the global effort to repair the Earth’s protective ozone layer and save millions of lives through the prevention of skin cancer.”

 

CFCs damage the ozone layer, a thin, outer layer in the stratosphere that acts as earth’s shield against the sun’s radiation. The United States and most other countries signed an agreement in 1987 called the Montreal Protocol on Substances that Deplete the Ozone Layer to phase out the worldwide production and use of CFCs. In the United States, CFCs have been removed from such products as hairsprays, deodorants and air conditioning.

 

For more information:

  • Phase-Out of CFC Metered-Dose Inhalers  http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm063054.htm
  • Drug Treatments for Asthma and COPD that Do Not Use CFCs http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm082370.htm
  • Consumer Update: Users of Last CFC Inhalers Must Soon Switch http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm353701.htm

 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

#

Originally Posted: FDA.gov 

 

 

Enhanced by Zemanta

Patients with COPD show improvements in lung function with Olodaterol

Patients with COPD show improvements in lung function with Olodaterol

Patients with COPD show improvements in lung function with Olodaterol

 

Patients with COPD show improvements in lung function with Olodaterol

 

NBN Infusions provides a comprehensive nursing and pharmacy program that services patients of all ages from pediatrics to geriatrics. NBN’s on-site, licensed pharmacy provides all required medications and equipment that patients will need for the duration of their home infusion therapy. Home Infusion Therapy involves the administration of medications using intravenous, subcutaneous and epidural routes. This care is administered to patients in the convenient and comfortable surroundings of their own home and allows them to take a more active role in their own health care. Home Infusion Therapy is not only more cost-effective than inpatient treatment, it eases the stress and anxiety of treatment resulting in better patient outcomes.

 

Data from the olodaterol Phase 3 clinical program, presented for the first time at the European Respiratory Society (ERS) Annual Congress 2013 in Barcelona, showed the addition of olodaterol 5 and 10 µg delivered once daily via the Respimat® inhaler provided improvements in lung function in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Olodaterol is an investigational long-acting beta agonist (LABA) currently being studied as a once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

 

These data are from two sets of replicate, 48-week pivotal studies evaluating the long-term efficacy and safety of once-daily olodaterol in 5 and 10 µg doses, as well two sets of replicate, 6-week studies investigating olodaterol’s 24-hour bronchodilation profile. In an effort to more accurately represent the clinical practice setting, patients involved in the Phase 3 program were allowed to continue their usual care, with the exception of LABAs. Usual care included long- and short-acting anticholinergics, short-acting beta agonists, inhaled corticosteroids (ICS) and xanthines.

 

“Despite advances in the treatment of COPD, there remains a significant need to reduce the burden of COPD on patients’ lives,” said lead study author Gary T. Ferguson, MD, of the Pulmonary Research Institute of Southeast Michigan, Livonia, Michigan. “We are excited about these data because we see that the lung function improvements shown with olodaterol may translate into patient-related benefits over and above those seen with usual care, and these improvements on top of permitted bronchodilator therapies makes these positive results even more noteworthy.”

 

Of the more than 20 presentations from the Boehringer Ingelheim lung health portfolio being presented at this year’s ERS Congress, five are from the Phase 3 olodaterol clinical program.

 

“We are encouraged by these findings and have an ongoing commitment to bringing new treatment options to patients with COPD,” said Tunde Otulana, MD, senior vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Our leadership role in lung health is driven by our heritage and passion for finding ways to address the unmet needs of the millions of Americans living with debilitating lung diseases such as COPD.”

 

Key Results from the 48-Week Phase 3 Olodaterol Studies

 

In one set of 48-week, Phase 3 pivotal studies (NCT00782210 and NCT00782509), olodaterol 5 and 10 µg delivered once daily via the Respimat® inhaler provided statistically significant improvements in lung function, as measured by FEV1, versus placebo plus usual care in patients with moderate to very severe COPD (P < 0.05; n=613 and 635).

 

In a second set of 48-week studies (NCT00793624 and NCT00796653), the same dose and delivery of olodaterol provided comparable improvements in lung function compared to 12 µg formoterol twice daily in these COPD patients (n=904 and 934). After 24 weeks of treatment, both doses of olodaterol and formoterol provided statistically significant improvements in FEV1 AUC0-3.

 

Olodaterol 5 µg was shown to provide significant improvement (P < 0.0001) in lung function within five minutes following the first dose.

 

In addition, COPD patients had less need for both day- and night-time rescue medication when using both doses of olodaterol (5 and 10 µg) delivered once daily via the Respimat® inhaler and formoterol versus placebo over the 48-week treatment period (P < 0.01).

 

In these studies, there was no significant difference in adverse events between the olodaterol treatment arm and the control arm with 71.0 percent of patients receiving olodaterol 5 µg reporting an adverse event compared to 72.7 percent of patients receiving olodaterol 10 µg, 70.8 percent of patients receiving placebo and 69.1 percent of patients receiving formoterol 12 µg. The most common adverse reactions were nasopharyngitis, dizziness, rash and arthralgia.

 

Key Results from the 6-Week Phase 3 Olodaterol Studies

 

In the two replicate, randomized, double-blind, placebo-controlled crossover studies, patients received olodaterol 5 µg and 10 µg delivered once daily via the Respimat® inhaler, tiotropium 18 µg once daily via the HandiHaler® or placebo in addition to usual care (ICS and xanthines) for 6 weeks (n=108 and 122).

 

The data presented at ERS showed that the improvements seen in lung function with olodaterol, as measured by FEV1 responses, were maintained over 24 hours (P < 0.001).

 

In these studies, there was no significant difference in adverse events between the olodaterol treatment arm and the placebo arm.

 

Reported Adverse Events – Study 1:

 

Olodaterol 5 µg: 31.7 percent

Olodaterol 10 µg: 33.7 percent

Placebo: 34.3 percent

Reported Adverse Events – Study 2:

 

Olodaterol 5 µg: 35.7 percent

Olodaterol 10 µg: 38.9 percent

Placebo: 33.9 percent

The most common adverse reactions were nasopharyngitis, COPD, cough and dyspnea.

 

About the Olodaterol Phase 3 Clinical Program

 

Olodaterol’s efficacy as a once-daily bronchodilator in patients with COPD is being investigated in a robust clinical trial program, involving more than 3,500 patients with moderate to very severe COPD (stages II, III and IV as defined by the Global Initiative for Chronic Obstructive Lung Disease [GOLD]).

 

Olodaterol is being investigated to determine the medicine’s efficacy in treating COPD patients and is not currently approved for this indication.

 

About COPD

 

Chronic obstructive pulmonary disease (COPD) includes chronic bronchitis and emphysema. This disease makes it harder to breathe because less air is able to flow in and out of the lungs. As many as 26 million Americans may have COPD – even those who haven’t smoked in years – and nearly half of them remain undiagnosed. COPD is the third leading cause of death in the United States. It kills one person every four minutes in the United States.

 

Common symptoms of COPD include shortness of breath and coughing with or without excess mucus.

 

Leading Respiratory Forward

 

Through research, treatments and patient-centric support services, the Boehringer Ingelheim lung health portfolio is designed to help address the challenges people living with a lung disease face every day. Leveraging the company’s cutting edge science and leadership in chronic obstructive pulmonary disease (COPD), Boehringer Ingelheim is researching new treatment approaches where needs persist. It is the company’s goal to make a difference in the lives of patients with COPD, asthma, lung cancer, idiopathic pulmonary fibrosis and other respiratory diseases.

 

About Boehringer Ingelheim Pharmaceuticals, Inc.

 

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

 

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

 

As a central element of its culture, Boehringer Ingelheim has a demonstrated commitment to corporate social responsibility. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

 

In 2012, Boehringer Ingelheim achieved net sales of about $19.1 billion (14.7 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

 

Original post: FierceBiotech.com

 

If you have COPD and you would like more information contact NBN Infusions using the form below.