Boehringer Releases Positive Update on OTEMTO Phase III Trial Findings Showing Superior Clinical Performance of Spiolto Respimat

Boehringer Ingelheim recently released a report on the company’s findings from the Phase IIIb OTEMTO 1 (NCT01964352) & 2 (NCT02006732) clinical trials, which are testing combination treatment Spiolto® Respimat® (tiotropium/olodaterol) for patients with chronic obstructive pulmonary disease (COPD). The update is published in the journal Respiratory Medicine. entitled, “Tiotropium+olodaterol shows clinically meaningful improvements in quality of life.”

In COPD, patients’ quality of life is measured by the St. George’s Respiratory Questionnaire (SGRQ), a disease-specific patient-reported instrument that evaluates symptoms including frequency and duration of cough, wheezing and breathlessness. Recent data from the OTEMTO studies reveal the treatment’s superior ability to reduce patients’ SGRQ score by 4.67, compared to those given a placebo.

Dave Singh, a Professor of clinical pharmacology and respiratory medicine at University of Manchester, and lead investigator of the OTEMTO® trials, said, “The improvement in quality of life provided by Spiolto® Respimat® in these trials could make a noticeable difference to the daily activity of COPD patients and enable them to maintain a more independent life. For example, this could mean that patients are able to walk up stairs without stopping, go out to socialise with friends or find it easier to wash and dress. Essentially, the data show that patients feel much better.”

The recently published report on the 1,600-large OTEMTO trial also revealed the following points on Spiolto Respimat:

• Clinically meaningful improvements in breathlessness compared to placebo (measured by a 1.62 point improvement in TDI focal score), reflecting the meaningful quality of life benefits.
• Consistent improvements in lung function, breathlessness and quality of life compared to Spiriva® (tiotropium).
• A safety profile similar to Spiriva® or placebo. Incidence of adverse events (AEs) was broadly similar across treatment groups, with a higher incidence of AEs leading to discontinuation in the placebo groups compared to the treatment groups.

The two OTEMTO trials pick up from the vital findings of the Phase III TONADO trials, which evidenced the combination treatment’s improved ability to clinically enhance pulmonary function, breathlessness and patients’ quality of life, and reduce the need for rescue medication, compared to Spiriva® Respimat®. OTEMTO 1&2 falls under one of the largest COPD clinical trial programs to date, the TOviTO® Phase III clinical trial program, which is estimated to enroll up to 15,000 patients.