A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)
A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)
Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.
Inclusion criteria:
All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
Male or female patients 40 years of age or older.
Patients must be current or ex-smokers with a smoking history of ≥10 pack-years. (Patients who have never smoked cigarettes must be excluded)
All patients must have a diagnosis of COPD (P06-12085), and must meet the following criteria: Relatively stable airway obstruction with a post-bronchodilator FEV1 ≤ 70% of predicted normal and post-bronchodilator FEV1 / FVC ≤70%.
Pulmonary function tests (PFTs) were conducted after the inhalation of 400 μg salbutamol / albuterol (preferred), however testing with either 200 μg salbutamol/albuterol or a combination of salbutamol / albuterol with ipratropium bromide (2 to 4 actuations) was acceptable. Other short-acting beta agonists, such as terbutaline, may have been used for the testing. The medication used for the testing was documented. Further, historical data from measurements within the past 6 months either at the site or at a referral site may have been used (see Section 6.2.1 of the CTP, located in Appendix 16.1.1). Subjects were not to have been randomized to the study without the availability of spirometry data at the actual study site.
Eligibility for PFT sub-study: For subjects participating in the spirometry sub-study, historical data may not have been used for inclusion. These subjects must have qualified in the clinic at Visit 1 after performing a baseline measurement. These subjects performed a pre-dose PFT which was followed by the administration of 400 μg salbutamol / albuterol only (no other short-acting beta agonist was allowed), followed by a post-dose PFT for qualification.
Able to inhale from the HandiHaler® and the Respimat® devices.
Exclusion criteria:
Pheonix, Arizona, United States
Downer Grove, Illinois, United States
Elizabeth City, North Carolina, United States
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Passo Fundo - RS, Brazil
Sao Pablo, Brazil
Grand Falls-Windsor, Newfoundland and Labrador, Canada
Mount Pearl, Newfoundland and Labrador, Canada
St. John's, Newfoundland and Labrador, Canada
St. John's, Newfoundland and Labrador, Canada
Point Claire, Quebec, Canada
Bourg Des Cptes, France
Serres Casset, France
Six Four Les Plages, France
Ense, Germany
Käbschütztal-Krögis, Germany
Rodgau-Dudenhofen, Germany
Nivel 12, Guatemala
Nivel Guatemala, Guatemala
Nivel Guatemala, Guatemala
Nivel Guatemala, Guatemala
Farkasgyepü, Hungary
Hajduböszörmeny, Hungary
Karnataka, India
Maharashtra, India
Maharastra, India
Punjab, India
Co. Cork, Ireland
Co. Tipperary, Ireland
Co. Wexford, Ireland
Offaly, Ireland
Sarawak, Malaysia
Terengganu, Malaysia
Zona Río, Mexico
Newtown Wellington NZ, New Zealand
Marbella, Panama
Marbella, Panama
Jesús Maria, Peru
Gorzow Wlkp, Poland
Ostrow Wielkopolska, Poland
Tranow, Poland
Daejoen, South Korea
Gangwon-Do, South Korea
Järfälla, Sweden
Taoyuan County, Taiwan
Hatyai, Songkhla, Thailand
Crimea, Ukraine
Dnipropetrovks, Ukraine
Dnyepropyetrovsk, Ukraine
Saint Just, Penzance, United Kingdom