Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma II

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on quality of life, effects on asthma control, effects on health care resource utilisation, and number of adverse events.

Key facts

Study ID: NCT01172821
Run by: Boehringer Ingelheim
People needed: 1032
Starts: 2010-08-01
Expected to finish: 2012-11-01
Last updated by the study team: 2014-06-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test at Visit 1).
Male or female patients aged at least 18 years but not more than 75 years.
All patients must have at least a 3 month history of asthma at the time of enrolment into the trial. The diagnosis should be confirmed at Visit 1 by fulfilling inclusion criterion 5.
The initial diagnosis of asthma must have been made before the patient's age of 40.
The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility (15 minutes after 400 mcg salbutamol (albuterol)) resulting in a Forced Expiratory Volume in one second (FEV1) increase of at least 12% and at least 200mL.
All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids for at least for 4 weeks prior to Visit 1. 7. All patients must be symptomatic at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of at least 1.5.
All patients must have a pre-bronchodilator FEV1 at least 60% and less than or equal to 90% of predicted normal at Visit 1.
Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%.
Patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment (Visit 0) and who have a smoking history of less than 10 pack years.
Patients must be able to use the Respimat® inhaler and metered dose inhaler correctly.
Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of electronic diary/peak flow meter.

You may not qualify if…

Patients with a significant disease other than asthma. A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial.
Patients with a clinically relevant abnormal screening (Visit 1) haematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion 1.
Patients with a recent history (i.e. six months or less) of myocardial infarction.
Patients who have been hospitalised for cardiac failure during the past year.
Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
Patients with lung diseases other than asthma (e.g. Chronic Obstructive Pulmonary Disease (COPD)).
Patients with known active tuberculosis.
Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion no. 1.
Patients with significant alcohol or drug abuse within the past two years.
Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to Visit 1 (screening).
Patients with known hypersensitivity to anticholinergic drugs, benzalkonium chloride (BAC), ethylenediamineteraacetic acid (EDTA), salmeterol xinafoate or any other components of the study medication delivery systems.
Pregnant or nursing woman.
Women of childbearing potential not using a highly effective method of birth control.
Patients who have taken an investigational drug within four weeks prior to Visit 1.
Patients who have been treated with beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period. Topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed.
Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within four weeks prior to Visit 1 and/or during the screening period.
Patients who have been treated with oral or patch beta-adrenergics within four weeks prior to Visit 1 and/or during the Screening period.
Patients who have been treated with oral corticosteroids within four weeks prior to Visit 1 and/or during the screening period.
Patients who have been treated with anti-IgE antibodies, e.g. omalizumab (Xolair®), within 6 months prior to Visit 1 and/or during the screening period.
Patients who have been treated with cromone within two weeks prior to Visit 1 and/or during the screening period.
Patients who have been treated with methylxanthines or phosphodiesterase 4 inhibitors within two weeks prior to Visit 1 and/or during the screening period.
Patients who have been treated with other non-approved and according to international guidelines not recommended "experimental" drugs for routine asthma therapy within four weeks prior to Visit 1 and/or during the screening period.
Patients with any asthma exacerbation or any respiratory tract infection iin the four weeks prior to Visit 1 and/or during the screening period.
Patients who have previously been randomised in this trial or in the respective twin trial (205.418) or are currently participating in another trial.

Where it is running

205.419.01053 Boehringer Ingelheim Investigational Site — Stockton, California, United States
205.419.01061 Boehringer Ingelheim Investigational Site — Centennial, Colorado, United States
205.419.01066 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
205.419.01064 Boehringer Ingelheim Investigational Site — Panama City, Florida, United States
205.419.01060 Boehringer Ingelheim Investigational Site — Winter Park, Florida, United States
205.419.01068 Boehringer Ingelheim Investigational Site — Novi, Michigan, United States
205.419.01054 Boehringer Ingelheim Investigational Site — Plymouth, Minnesota, United States
205.419.01062 Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
205.419.01070 Boehringer Ingelheim Investigational Site — Bozeman, Montana, United States
205.419.01067 Boehringer Ingelheim Investigational Site — Skillman, New Jersey, United States
205.419.01071 Boehringer Ingelheim Investigational Site — Raleigh, North Carolina, United States
205.419.01055 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
205.419.01065 Boehringer Ingelheim Investigational Site — Portland, Oregon, United States
205.419.01069 Boehringer Ingelheim Investigational Site — Greenville, South Carolina, United States
205.419.01056 Boehringer Ingelheim Investigational Site — Union, South Carolina, United States
205.419.01063 Boehringer Ingelheim Investigational Site — El Paso, Texas, United States
205.419.01051 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
205.419.55053 Boehringer Ingelheim Investigational Site — Florianópolis, Brazil
205.419.55054 Boehringer Ingelheim Investigational Site — Porto Alegre, Brazil
205.419.55052 Boehringer Ingelheim Investigational Site — São Paulo, Brazil
205.419.55055 Boehringer Ingelheim Investigational Site — São Paulo, Brazil
205.419.86061 Boehringer Ingelheim Investigational Site — Chengdu, China
205.419.86053 Boehringer Ingelheim Investigational Site — Chongqing, China
205.419.86056 Boehringer Ingelheim Investigational Site — Guangzhou, China
205.419.01058 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.