COPD Treatment a Clinical Trial Success

Glycopyrrolate had positive results in phase 2b clinical trials

December 10, 2011 / Author:  / Reviewed by: Joseph V. Madia, MD

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(dailyRx News) Patients with moderate-to-severe COPD may have a new treatment option on the way. A new drug has been generating positive results in clinical trials and could improve lung function and ease symptoms.

Phase 2b clinical trials of Glycopyrrolate (GP MDI; PT001) have been successful so far. Using GP MDI twice a day via inhaler showed significant improvements in lung function when compared to a placebo. These positive results mean GP MDI could be begin Phase III trials in 2012.

"Ask your doctor about clinical trials. "

Phase 2b clinical testing evaluates the drug's effectiveness at the prescribed dosage. The clinical trial tested the effective of four doses of GP MDI against four doses of a placebo and the U.S. Food and Drug Administration (FDA) approved COPD treatment, Atrovent.

GP MDI's results were similar to Atrovent. Additionally, GP MDI was considered safe and was well-tolerated among patients. A phase 3 trial would begin in 2012. Phase 3 trials test the drug on a much larger population and against the best current FDA-approved treatment.

GP MDI is an interesting candidate because it is quicker acting than long-acting beta-adrenoceptor agonist (LABA). LABA's, such as Advair, work over a long period of time, up to 12 hours. LABA's would be used as an alternative to multiple doses of an inhaled corticosteroid.

GP MDI is a Long-Acting Muscarinic Agonist (LAMA) which could be combined with a LABA to improve treatment.

According to Chuck Bramlage, chief executive officer for Pearl Therapeutics, GP MDI can help fill a gap in COPD treatment because there is no quicker alternative to the sustained treatment of a LAMA. Mr. Bramlage says,

“A significant part of the very large COPD market is driven by the use of BID (twice daily) LABAs and inhaled corticosteroids. However, a rapid-acting, BID LAMA to complement these options is not yet available.”

GP MDI will be used in combination with a LABA for a combined treatment called PT003. With successful results in a Phase 3 trial, PT003 can be marketed and sold but will continue to be evaluated for safety and effectiveness.

GP MDI could be a new treatment for moderate-to-severe COPD pending future clinical trial results. Considering how deadly COPD is, any new treatment is eagerly anticipated.

Reviewed by: 
Review Date: 
December 9, 2011
Last Updated:
September 27, 2012