Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
40–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice guidelines prior to participation in the trial, including medication washout and restrictions
Diagnosis of Chronic Obstructive Pulmonary Disease and relatively stable airway obstruction: post bronchodilator 30%\<= Forced Expiratory Volume in 1st second (FEV1)\<80% of predicted normal (European Coal and Steel Community) and a post bronchodilator FEV1/Forced Vital Capacity\<0.70 at visit 1
Male or female patients \>=40 and =\<75 years of age on day of signing consent.
Current or ex-smokers with a smoking history \> 10 pack-years. Patients who have never smoked cigarettes must be excluded.
Baseline Dyspnea Index score\< 8 at visit 0.
Hyperinflation at rest, defined as Functional Residual Capacity \> 120% predicted at visit 1.
Borg dyspnea score \>=4 at the end of 3min Constant Speed Shuttle Test at visit 2
Perform technically acceptable pulmonary function tests (spirometry and body plethysmography) and complete multiple shuttle tests during the study period
Inhale medication in a competent manner from the Respimat® inhaler and from a metered dose inhaler
You may not be if
Significant disease other than Chronic Obstructive Pulmonary Disease (COPD); a significant disease which, in the investigator's opinion, may (i) put the patient at risk (ii) influence the study results or (iii) cause concern regarding the patient's ability to participate
Clinically relevant abnormal baseline haematology, blood chemistry, in the investigator's opinion, or creatinine \>x2 Upper Limit Normal will be excluded regardless of clinical condition
Current documented diagnosis of asthma
COPD exacerbation in the 6 weeks prior to screening
Diagnosis of thyrotoxicosis
History of myocardial infarction within 6 months of screening
Severe emphysema requiring endobronchial interventions within 6 months prior to screening
History of significant alcohol or drug abuse (investigator judgment)
Any contraindications for exercise testing
Patients who have undergone thoracotomy with pulmonary resection
Treatment with any oral or patch ß-adrenergics
Treatment with oral corticosteroid medication at unstable doses or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
Treatment with antibiotics for any reason within 4 weeks of screening
Patients being treated with Phosphodiesterase Type 4 (PDE4) inhibitors within 3 months of screening visit should not be enrolled and PDE4 inhibitors should not be withdrawn for the purpose of enrolling in this study
Regular use of daytime oxygen therapy for \>1 hour per day and in the investigator's opinion will be unable to abstain from use during clinic visits
Completion of a pulmonary rehabilitation program 6 weeks prior to screening or currently in a program
Limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea, such as arthritis in the leg, angina pectoris, claudication, morbid obesity
Endurance time \>=12 minutes during the incremental shuttle walk test
Oxygen saturation \< 85% (on room air) at rest or during exercise.
Taken an investigational drug within 1 month or 6 half-lives or in case the investigational drug class is listed within the washout period specified prior to screening visit
Known hypersensitivity to ß-adrenergics and/or anticholinergic drugs, Benzalkonium Chloride, Ethylenediaminetetraacetic acid or any other component of the Respimat® inhalation solution
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Women of childbearing potential not using a highly effective method of birth control
Previously been randomized in this study or are currently participating in another study
Unable to comply with pulmonary medication restrictions prior to randomization
Clareo Health | Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients
