Health Condition 1: null- Asthma
Conditions
Interventions
Intervention1: Tiotropium: 5 mcg once daily delivered via Respimat inhaler for 12 weeks
Intervention2: Tiotropium: 2.5 mcg once daily delivered via Respimat inhaler for 12 weeks
Intervention3: Place
Sponsors
Boehringer Ingelheim Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation prior to participation in the trial that is prior to any trial procedures including any pretrial washout of medications and medication restrictions for pulmonary function test at Visit 1 Male or female patients aged 18 years or more at Visit 0 and 75 years or less at Visit 0 All patients must have at least a 3 months history of asthma at the time of enrolment into the trial The initial diagnosis of asthma must have been made before the patients age of 40 A pre bronchodilator Forced Expiratory Volume in 1 second FEV1 equal to 60 percent predicted and equal to 90 percent of predicted normal at Visit 1 Variation of absolute FEV1 values of Visit 1 prebronchodilator as compared to Visit 2 pre dose must be within plus minus 30 percent Patients diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility within 10 minutes pre and 15 to 30 minutes after 400 micro gram salbutamol or albuterol resulting in a FEV1 increase of equal to 12 percent and equal ro200mL. If this is not achieved the reversibility test may be repeated once within two weeks All patients must be symptomatic despite their current maintenance treatment with low doses of inhaled corticosteroids All patients must be symptomatic at Visit 1 screening and Visit 2 as defined by an Asthma Control Questionnaire mean score of equal ro 1.5 All patients must have been on maintenance treatment with a low stable dose of inhaled corticosteroids for at least 4 weeks prior to Visit 1 Patients must be never smokers or ex smokers who stopped smoking at least one year prior to enrolment and who have a smoking history of less than 10 pack years Patients must be able to use the Respimat inhaler correctly Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of the e Diary or peak flow meter eDiary compliance of at least 80 percent is required Patients taking a chronic pulmonary medication allowed by the study protocol must be willing to continue this therapy for the entire duration of the study exception times of acute disease deterioration
Exclusion criteria
Exclusion criteria: Patients with a significant disease other than asthma. A significant disease is defined as a disease which in the opinion of the Investigator may put the patient at risk because of participation in the trial or cause concern regarding the patients 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 number 1 Patients requiring more than 10 puffs of rescue medication salbutamol oralbuterol MDI per 24 hours on 2 consecutive days during the screening period Patients with a recent history that is six months or less of Acute Coronary Syndrome that is STEMI Non STEMI and Unstable Angina Pectoris 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 eg 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 on Investigators assessment 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 or BAC or EDTA or any other components of the tiotropium inhalation solution Pregnant or nursing woman including female patients with positive beta HCG test at Visit 1 Female patients of child-bearing potential not using highly effective method of birth control As defined in ICH 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 oral or patch beta adrenergics systemic that is oral or intravenous corticosteroids long acting anticholinergic tiotropium or Spiriva within four weeks prior to Visit 1 and or during the screening period Patients who have been treated with depot corticosteroids within six months prior to Visit 1 and or during the screening period Patients who have ever been treated with anti IgE antibodies Patients who have been treated with leukotriene modifiers systemic anticholinergics cromolyn sodium or nedocromil sodium and methylxanthines or phosphodiesterase 4 inhibitors within two weeks prior to Visit 1 and or during the screening period Patients who have been treated with inhaled long acting beta adrenergics and long acting beta adrenergics combination products within four weeks prior to Visit 0 and or during the screening period Patients who have taken an investigational drug within four weeks or six half lives whichever is greater prior to Visit 1 Patients who have been treated with other non-approved and according to i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline at the end of 12 week treatment period in the highest forced expiratory volume in one second observed within 3 hours post evening trial drug administration (peak FEV1 0-3 hours response)Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline at the end of 12 week treatment period in the area under the curve from zero to 3 hours of the trough forced expiratory volume and forced vital capacityTimepoint: 12 weeks;Change from baseline at the end of 12 week treatment period in the highest forced vital capacity observed within 3 hours post evening trial drug administrationTimepoint: 12 weeks;Change from baseline at the end of 12 week treatment period in the trough forced expiratory volume in one second (trough FEV1 response)Timepoint: 12 weeks;Number of inhalations of salbutamol/albuterol rescue medication used per day (24 hours; day time; night time) during the entire study period. Weekly means will be comparedTimepoint: 0- 19 weeks;The number of responders (improvement of at least 0.5 for the ACQ) as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 12 week treatment periodTimepoint: 12 weeks;Time to first asthma exacerbation during the 12 week treatment periodTimepoint: 0- 12 weeks;Time to first severe asthma exacerbation during the 12 week treatment periodTimepoint: 0- 12 weeks | — |
Countries
Austria, Croatia, Estonia, Guatemala, Hungary, Italy, Latvia, Poland, Republic of Korea, Slovakia
Contacts
Public ContactDr Partha Gokhale
Boehringer Ingelheim India Pvt. Ltd.
Outcome results
None listed