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Asthma Drug Tiotropium Improves Lung Function in Phase III Trials
Positive data from five phase III studies of investigational tiotropium (Boehringer Ingelheim) delivered via the Respimat inhaler have been presented at the 2015 American Academy of Allergy, Asthma, and Immunology annual meeting in Houston, Texas.
The studies included:
- Two PrimoTinA-asthma trials in patients with severe asthma who remained symptomatic while receiving high-dose inhaled corticosteroid (ICS) therapy plus long-acting beta agonist (LABA) therapy
- Two MezzoTinA-asthma trials in patients with moderate asthma who remained symptomatic while receiving medium-dose ICS therapy
- One GraziaTinA-asthma trial in patients with mild asthma who remained symptomatic while receiving low-dose ICS treatment
Pre-planned analyses showed that the addition of tiotropium Respimat improved lung function, as measured by the peak forced expiratory volume in one second (FEV1(o-3hr)) and the trough FEV1, independent of underlying allergic status, in adult patients with mild, moderate, or severe asthma who continued to experience symptoms despite the use of maintenance therapies.
Tiotropium is being studied as a once-daily, add-on treatment in asthma patients who continue to experience symptoms (e.g., wheezing, shortness of breath, chest tightness and cough), despite the use of maintenance therapy, including ICS therapy with or without LABAs. The drug is not currently approved for this indication.
The studies included in the new analyses were double-blind, placebo-controlled, parallel-group trials in adult patients with mild, moderate, or severe asthma. A total of 3,480 patients were randomly assigned to receive tiotropium 5.0 mcg, tiotropium 2.5 mcg, or placebo in addition to ICS therapy with or without LABAs in the five studies. The patients were permitted to receive additional background treatment, which included antihistamines, anti-allergic agents, nasal steroids, and omalizumab.
In all five studies, the peak FEV1 (0-3hr) and the trough FEV1 significantly improved with the addition of tiotropium delivered via the Respimat inhaler compared with placebo, irrespective of the patient’s underlying allergic status.
Adverse event (AE) data were pooled from the five trials. The most common AEs included asthma, bronchitis, decreased peak expiratory flow rate, headache, nasopharyngitis, and upper respiratory tract infection.
As of December 2012, an estimated 300 million people have asthma worldwide. Despite current treatment options, approximately 40% of patients remain symptomatic. The disease cannot be cured.
Source: Boehringer Ingelheim; February 21, 2015.