Investigational tiotropium shown to improve symptoms of moderate asthma

Boehringer Ingelheim presented a pooled analysis of new data from the phase 3 UniTinA-asthma program at the European Respiratory Society (ERS) Annual Congress 2013 in Barcelona, Spain, recently.

The data from the individual MezzoTinA-asthma phase 3 studies (NCT01172808 and NCT01172821), from which the pooled data are derived, show the addition of tiotropium delivered via the Respimat inhaler to medium-dose maintenance inhaled corticosteroid (ICS) therapy (defined as 400-800 µg budesonide/day or equivalent) improved lung function and provided sustained bronchodilation over 24 hours in patients with moderate asthma and airflow limitation.

Tiotropium is being investigated to determine efficacy in treating asthma patients and is not currently approved for this indication.

These new data from the MezzoTinA-asthma phase 3 studies also showed the addition of once-daily tiotropium delivered via the Respimat inhaler provided a statistically significant improvement in asthma control responder rate, as measured by the Asthma Control Questionnaire (ACQ).

In the individual trials and the pooled analysis presented, the mean change in peak FEV₁ at 24 weeks from baseline versus placebo was significantly improved for all 3 active treatments. Additionally, the mean change in trough FEV₁ at 24 weeks from baseline versus placebo in the individual trials, as well as in the pooled data presented at ERS, was significantly improved for all 3 active treatments.

To characterize the treatment response as greater than or equal to 0.5, measured by the ACQ, treatment with tiotropium (2.5 μg and 5 μg) resulted in a statistically significant improvement in the ACQ responder rate at 24 weeks compared with placebo and comparable to that of salmeterol. ACQ responder rates, performed on the pooled MezzoTinA-asthma results, were as follows:

• Placebo: 57.7% (n=299/518)

• Tiotropium 2.5 μg once daily: 64.5% (n=332/515; P=.03)

• Tiotropium 5 μg once daily: 64.3% (n=330/513; P=.03)

• Salmeterol 50 μg twice daily: 66.5% (n=356/535; P=.004)

Patients in the MezzoTinA-asthma studies were permitted to receive additional background therapy, including antihistamines, nasal steroids and leukotriene modifiers. Long-acting beta agonists (LABAs) were not permitted during the study (salmeterol was included as an active comparator for the trial).

Adverse events were balanced across the 4 treatment groups in the pooled analysis with 58.2% of patients receiving tiotropium 2.5 μg once daily reporting an adverse event compared to 57.3% of patients in the tiotropium 5 μg once daily group, 54.3% of patients who received salmeterol 50 μg twice daily and 59.1% of patients receiving placebo. The most commonly reported adverse events were asthma, peak expiratory flow (PEF) rate decreased, nasopharyngitis and upper respiratory tract infection. Adverse events reported by Preferred Term; MedDRA v 15.1 was used).

The MezzoTinA-asthma set of replicate studies show results in patients with moderate persistent asthma and build on previous positive study results for tiotropium from the PrimoTinA-asthma studies in patients with severe asthma. 

“At least 40% of asthma patients remain symptomatic despite current standard treatment options and may experience asthma exacerbations [attacks],” said Alan H. Cohen, MD, executive director, clinical development & medical affairs – respiratory, Boehringer Ingelheim. “They can continue to have symptoms and lifestyle restrictions and might even require emergency care.

“These data increase our understanding of tiotropium’s potential efficacy across asthma severities as an add-on asthma treatment for patients who continue to experience symptoms despite current standard treatments,” added Dr Cohen.