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COPD is a progressive disease characterized by airflow obstruction or limitation. Emphysema is characterized by loss of elasticity of the lung tissue, destruction of structures supporting the alveoli and of capillaries feeding the alveoli. Both have symptoms that include shortness of breath, among other respiratory troubles. If you are a COPD or Emphysema sufferer, join...
October 28, 2011 (Honolulu, Hawaii) Two big clinical trials of mometasone furoate with formoterol (Dulera, Merck) found the combination safe and effective in improving the lung function of patients with moderate to very severe chronic obstructive pulmonary disease (COPD), researchers reported here at CHEST 2011, the Annual Meeting of the American College of Chest Physicians (ACCP).
"These two medications seem to do pretty well" in comparison to combination COPD drugs already on the market, the study's first author, Dennis E. Doherty, MD, told Medscape Medical News.
The trials are part of Merck's application to the US Food and Drug Administration (FDA) to approve Dulera for COPD. It is already approved for asthma.
If Dulera wins approval for COPD, it could take its place alongside GlaxoSmithKline Advair and AstraZeneca Symbicort as a central therapy for the syndrome, said Dr. Doherty, a professor of medicine at the University of Kentucky in Lexington.
Like those 2 drugs, mometasone/formoterol brings together in 1 inhaler a long-acting -agonist (formoterol) with a steroid (mometasone). Formoterol is already approved as single-drug therapy for COPD.
Merck created 2 separate trials with identical designs to meet an FDA requirement.
Both trials enrolled about 1000 patients who were older than 40 years of age, were diagnosed with moderate to severe COPD, had had symptoms for more than 2 years, had a smoking history of at least 10 pack-years, and had been using short-acting bronchodilators or short-acting anticholinergic medication for at least 2 weeks.
In each trial, patients were randomly divided into 5 groups with different treatments:
Mometasone, 200 g, combined with formoterol, 10 g;
Mometasone, 400 g, combined with formoterol, 10 g;
Mometasone alone, 400 g;
Formoterol alone, 10 g; and
Placebo.
The drugs were prescribed to be taken twice a day.
In both trials, all the active treatments improved lung function, as measured by forced expiratory volume in 1 second (FEV1) area under the curve over 0-12 hours at week 13.
In both studies, the improvement with mometasone 200 g/formoterol 10 g and mometasone 400 g/formoterol 10 g was significantly better than with mometasone alone (P < .007). The 2 combinations were also better than formoterol alone.
"The combination product was better than each individual component when looking at FEV1 area under the curve," said Dr. Doherty.
Patients receiving both doses of mometasone/formoterol also had fewer exacerbations than patients receiving placebo. In the second trial, the rate of exacerbations was 37.6% with 400 g mometasone/10 g formoterol, 32.2% with 200 g mometasone/10 g formoterol, and 45.7% with placebo.
The number of adverse reactions with active drug combinations was similar to that with placebo in both trials, ranging from 57 to 100 events. "Pretty much it was a fairly safe product," said Dr. Doherty.
He particularly noted a low incidence of pneumonia, an adverse reaction that has been a problem with some competing drugs.
Compared with drugs already on the market, mometasone/formoterol has a high-binding affinity to glucocorticoid receptors, so it should theoretically be less bioavailable outside the lung, said Dr. Doherty.
Mometasone/formoterol could make a significant difference for many patients with COPD, noted Paul W. Jones, MD, PhD, a professor of respiratory medicine at the University of London, United Kingdom, who was not involved in the study.
He told Medscape Medical News that several other new drugs using similar combinations of molecules are in the pipeline. "What's interesting is that none of these agents are new," he said. "The classes of molecule have been around for a long time, but they are being put together in new ways. And the health data is much better with the new drugs than with the old drugs."
Dr. Doherty disclosed that he has served as served as a consultant for pharmaceutical companies, including Merck. Dr. Jones's research has been supported by Almiral and other pharmaceutical companies, and he has served as an advisor to several pharmaceutical companies.
CHEST 2011: The Annual Meeting of the American College of Chest Physicians (ACCP). Abstract # 2423. Presented October 26, 2011.
http://www.medscape.com/viewarticle/752491
I thought that if you had not alread read this, that some of you might find it interesting.
Have an Easy Breathing day,
Love to all,
Holly
"These two medications seem to do pretty well" in comparison to combination COPD drugs already on the market, the study's first author, Dennis E. Doherty, MD, told Medscape Medical News.
The trials are part of Merck's application to the US Food and Drug Administration (FDA) to approve Dulera for COPD. It is already approved for asthma.
If Dulera wins approval for COPD, it could take its place alongside GlaxoSmithKline Advair and AstraZeneca Symbicort as a central therapy for the syndrome, said Dr. Doherty, a professor of medicine at the University of Kentucky in Lexington.
Like those 2 drugs, mometasone/formoterol brings together in 1 inhaler a long-acting -agonist (formoterol) with a steroid (mometasone). Formoterol is already approved as single-drug therapy for COPD.
Merck created 2 separate trials with identical designs to meet an FDA requirement.
Both trials enrolled about 1000 patients who were older than 40 years of age, were diagnosed with moderate to severe COPD, had had symptoms for more than 2 years, had a smoking history of at least 10 pack-years, and had been using short-acting bronchodilators or short-acting anticholinergic medication for at least 2 weeks.
In each trial, patients were randomly divided into 5 groups with different treatments:
Mometasone, 200 g, combined with formoterol, 10 g;
Mometasone, 400 g, combined with formoterol, 10 g;
Mometasone alone, 400 g;
Formoterol alone, 10 g; and
Placebo.
The drugs were prescribed to be taken twice a day.
In both trials, all the active treatments improved lung function, as measured by forced expiratory volume in 1 second (FEV1) area under the curve over 0-12 hours at week 13.
In both studies, the improvement with mometasone 200 g/formoterol 10 g and mometasone 400 g/formoterol 10 g was significantly better than with mometasone alone (P < .007). The 2 combinations were also better than formoterol alone.
"The combination product was better than each individual component when looking at FEV1 area under the curve," said Dr. Doherty.
Patients receiving both doses of mometasone/formoterol also had fewer exacerbations than patients receiving placebo. In the second trial, the rate of exacerbations was 37.6% with 400 g mometasone/10 g formoterol, 32.2% with 200 g mometasone/10 g formoterol, and 45.7% with placebo.
The number of adverse reactions with active drug combinations was similar to that with placebo in both trials, ranging from 57 to 100 events. "Pretty much it was a fairly safe product," said Dr. Doherty.
He particularly noted a low incidence of pneumonia, an adverse reaction that has been a problem with some competing drugs.
Compared with drugs already on the market, mometasone/formoterol has a high-binding affinity to glucocorticoid receptors, so it should theoretically be less bioavailable outside the lung, said Dr. Doherty.
Mometasone/formoterol could make a significant difference for many patients with COPD, noted Paul W. Jones, MD, PhD, a professor of respiratory medicine at the University of London, United Kingdom, who was not involved in the study.
He told Medscape Medical News that several other new drugs using similar combinations of molecules are in the pipeline. "What's interesting is that none of these agents are new," he said. "The classes of molecule have been around for a long time, but they are being put together in new ways. And the health data is much better with the new drugs than with the old drugs."
Dr. Doherty disclosed that he has served as served as a consultant for pharmaceutical companies, including Merck. Dr. Jones's research has been supported by Almiral and other pharmaceutical companies, and he has served as an advisor to several pharmaceutical companies.
CHEST 2011: The Annual Meeting of the American College of Chest Physicians (ACCP). Abstract # 2423. Presented October 26, 2011.
http://www.medscape.com/viewarticle/752491
I thought that if you had not alread read this, that some of you might find it interesting.
Have an Easy Breathing day,
Love to all,
Holly
Peta44
Interesting read, thanks Holly for posting.
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