Concomitant use of Perforomist, tiotropium improves COPD

Perforomist™ Inhalation Solution was approved in 2007 by the FDA for long-term, twice-daily maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is the only FDA-approved nebulized formoterol fumarate.

Donald P. Tashkin, MD, FACP, FCCP, Professor of Medicine, David Geffen School of Medicine at the University of California at Los Angeles and lead clinical investigator, presented the results from “Addition of Nebulized Formoterol Fumarate to Tiotropium Treatment Relieves Dyspnea and Symptoms in COPD Patients” in a poster session today.

“In this study there was a significant improvement in patients treated concomitantly with Perforomist™ nebulized formoterol fumarate and tiotropium over tiotropium alone,” said Dr. Tashkin. “These data provide physicians with a new and valuable treatment option for COPD patients with moderate to severe manifestations of the disease.”

This randomized, placebo-controlled double-blind trial was conducted in 130 patients with moderate to severe COPD to evaluate the efficacy and safety of Perforomist™, nebulized FFIS, when added to Spiriva maintenance treatment. Patient-centered outcomes were measured by the baseline/transitional dyspnea index, daily recording of COPD symptoms, rescue albuterol use and St. George’s Respiratory Questionnaire (SGRQ).

In this trial there was a statistical significance between the mean transitional dyspnea index scores in the Perforomist™/TIO and TIO/placebo groups (2.30 and 0.16, respectively; p=0.0002). Shortness of breath, chest tightness, nighttime awakenings, and total symptom scores all improved significantly with the Perforomist™/TIO treatment compared with TIO/placebo (p<0.05). Cough scores did not differ between groups. Albuterol use declined in the Perforomist™/TIO group from 2.4 to1.3 puffs/day and increased in the TIO/placebo group from 2.8 to 3.4 puffs/day over six weeks; another statistically significant difference (p< 0.0001). SGRQ total scores did not change markedly from baseline or differ between groups except for the symptom domain score, which was superior in the Perforomist™/TIO group compared to TIO/placebo (-6.3, p<0.04).

“DEY is very pleased with the results of this study and the benefit that patients are seeing with Perforomist™ Inhalation Solution,” said Carolyn Myers, Ph.D., President of Dey, L.P. “We wish to thank Dr. Tashkin and the other members of the research team for their careful investigation into the clinical benefits of concomitant therapy of Perforomist and tiotropium. At DEY, we are committed to developing effective new treatments for serious and complex diseases, and with Perforomist are proud to provide physicians and patients a twice-daily COPD maintenance medication that offers the flexibility of dosing via nebulization.”

For those attending ATS 2008, the presentation is available as follows:

Poster viewing: Session ID C42 COPD Pharmacotherapy I: Effects of Bronchodilators Tuesday, May 20, 2008, 10:45 a.m. – 12:30 p.m. EDT Metro Toronto Convention Center; Area F: Halls A-B North Building, Level 300

Poster # F4: Addition of Nebulized Formoterol Fumarate to Tiotropium Treatment Relieves Dyspnea and Symptoms in COPD Patients-Feinstein Kean Healthcare