Last updated 2 years ago
A multicenter, randomized, placebo-controlled, crossover, single dose study to demonstrate clinical pharmacodynamic bioequivalence of tiotropium 18 µg inhalation powder, hard capsule with Spiriva®Handihaler® 18 µg inhalation powder, hard capsule, in patients with chronic obstructive pulmonary disease (COPD).
324 patients around the world
Available in United States
Chemo Research S.L.
9Research sites
324Patients around the world
Requirements for the patient
To 75 years
All Gender
Medical requirements
- Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the Investigator, capable of giving written informed consent and being compliant with all study requirements (visits, study procedures such as pulmonary function tests, record-keeping, etc.).Male or non-pregnant female patients 40 to 75 years of age at Screening Visit (Visit 1) diagnosed with COPD who have signed informed consent prior to initiation of any study-related procedure.General good health (except the COPD diagnosis) and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study as per the discretion of the Investigator.An established physician diagnosis of COPD as defined by the American Thoracic Society (ATS) [Global Initiative for Chronic Obstructive Lung Disease (GOLD 2022)].At first (Visit 1) or second (Visit 2) Screening Visit, post-bronchodilator FEV1≤80% and ≥40% of predicted normal values as per Global Lung Function Initiative (GLI-2012) after 4 puffs of albuterol used as per GOLD 2022. Additionally, post-bronchodilator FEV1/FVC ratio ≤0.70.Predose FEV1 values at Visits 4 and 5 within ± 20% of the Visit 3 FEV1.Able to perform spirometry according to the defined acceptability and reproducibility criteria at the Screening Visit (Visit 1 or 2).Current COPD Therapy: Patients must be on stable regimens of one of the following for at least 8 weeks prior to screening (Visit 1): Long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA), LAMA+LABA, Inhaled corticosteroids + LABA, Inhaled corticosteroids + LAMA, Short-acting beta-agonist (SABA).All patients must be able to replace their current short-acting bronchodilators with study-provided albuterol inhalation aerosol provided at the Screening Visit (Visit 1) for use as needed for the duration of the study.Patients must be able to discontinue their COPD maintenance medications during the run-in and treatment periods.Patients must be able to withhold their short-acting β2-agonists for at least 6 hours prior to spirometry on each clinic visit at the discretion of the investigator.Current or ex-smoker with ≥10 pack-year smoking history (Note: Pack-Year= (cigarettes smoked per day x years smoked)/20)).Female patients may be of non-childbearing potential (postmenopausal, i.e., amenorrheal for >2 consecutive years, or naturally postmenopausal [no menses] for ≥1 year; surgically sterile [tubal ligation, bilateral oophorectomy, or hysterectomy], congenital sterility, or diagnosed as infertile and not undergoing treatment to reverse infertility) or if of childbearing potential committed to the consistent and correct use of an acceptable method of birth control and demonstrate a negative pregnancy test at the Screening Visit (Visit 1) and during the study.Male subjects, who are sexually active, committed to the consistent and correct use of an acceptable method of birth control for the duration of the study or exclusively have same-sex partners.No occurrence of an upper or lower respiratory tract infection during the run-in period.No COPD exacerbation, defined as any worsening of COPD requiring an emergency department visit or hospitalization, or requiring excessive use of the albuterol rescue medication (more than 3 puffs per day increase from the average daily usage) during the run-in period at the discretion of the Investigator, or the use of antibiotics during the run-in period.Patients should be able to tolerate the withdrawal of COPD medications during the study at the discretion of the Investigator.Patients must be able to perform the inhalation technique correctly. Patient must be able to demonstrate the ability to produce an adequate inspiratory flow rate for using the In-Check DIAL device mimicking the Handihaler device setting.Patient must be able to demonstrate the ability to produce an adequate inspiratory flow rate and technique using the AIM device in the DPI setting.Patient has completed diary data on a minimum of 5 days out of the last 7 days prior to randomization (not including the day of randomization) and has achieved a minimum of 70% compliance with the paper diary during the run-in period.
- Treatment for COPD exacerbation within 12 weeks prior to the Screening Visit (Visit 1) or 2 or more exacerbations in the last year.Hospitalization for COPD or pneumonia within 12 weeks prior to the Screening Visit (Visit 1).History of a life-threatening COPD episode that required intubation and/or was associated with hypercapnia, respiratory arrest, hypoxic seizures, or mMRC (Modified Medical Research Council) dyspnea Grade 4.Acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 8 weeks prior to the Screening Visit (Visit 1).Use of immediate-release (Oral or IV) corticosteroids within the last 30 days and/or extended-release corticosteroids (Depot or Local) within the last 12 weeks prior to the Screening Visit (Visit 2).Patients with a history of asthma or a clinical diagnosis of asthma, allergic rhinitis, or atopy; a total blood eosinophil count above 600/mm3.Patients with an abnormal/clinically significant 12-lead electrocardiogram (ECG) prior to and during screening visit, during the run-in and treatment periods.Patients with myocardial infarction or unstable angina in the last 12 months; unstable or life-threatening cardiac arrhythmia requiring intervention in the last 12 months; or New York Heart Association Class II-IV heart failure.Patients with documented pulmonary hypertension or clinical signs of right heart failure (indicated by an increase in jugular venous pressure with or without peripheral edema) or patients who require chronic oxygen use for >12 hours per day.Presence of glaucoma or a history/family history of glaucoma.History of paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder-neck obstruction, or any other condition, which, in the opinion of the Investigator, would contraindicate the use of an anticholinergic agent.Presence or history of urinary retention.Historical or current evidence of a clinically significant disease (Note: Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the patient at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.) including, but not limited to: Cardiovascular (e.g., congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, stroke, or non-controlled arrhythmias), Hepatic, renal, hematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison’s disease, and Cushing’s syndrome), Gastrointestinal (e.g., poorly-controlled peptic ulcer disease), Pulmonary disease other than COPD (e.g., alpha-1 antitrypsin deficiency, active bronchiectasis, cystic fibrosis, broncho-pulmonary dysplasia, sarcoidosis, lung fibrosis, pulmonary edema, interstitial lung disease, lung or mediastinum proliferative process including malignancies).Patients who have undergone thoracotomy with pulmonary resection, have plans to undergo lung transplantation or lung volume reduction therapy, or have had lung volume reduction surgery within 12 months prior to the Screening Visit (Visit 1).Have any of the following conditions that, in the judgment of the Investigator, might cause participation in this study to be detrimental to the patient, including but not limited to: Current malignancy excluding basal cell carcinoma. (Note: History of malignancy is acceptable only if the patient has been in remission for one year prior to the Screening Visit (Visit 1). Remission is defined as no current evidence of malignancy and no treatment for the malignancy in the 5 years prior to the Screening Visit (Visit 1). Current or untreated tuberculosis (Note: History of tuberculosis is acceptable only if a patient has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years). Uncontrolled hypertension (systolic blood pressure [BP] ≥160 or diastolic BP >100). Stroke within 12 months prior to the Screening Visit (Visit 1). Immunocompromised.A patient must not have any clinically significant, uncontrolled condition, or disease state that, in the opinion of the Investigator, would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study.History of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or specific intolerance to aerosolized tiotropium-containing products or its derivatives (e.g., ipratropium, oxitropium), or known hypersensitivity to any of the proposed ingredients or components of the delivery system.History of alcohol or drug abuse within 2 years prior to the Screening Visit (Visit 1).Study participation by the clinical Investigator site employees and/or their immediate relatives.Participation in any investigational drug study within the 30 days preceding the Screening Visit (Visit 1) or planned participation in another investigational drug study at any time during this study.Legal incapacity or other circumstances that render the patient unable to understand the nature, scope and possible consequences of the study
Sites
SIMED Health
Recruiting
Research Institute of South Florida
Recruiting
Southwest General Healthcare
Recruiting
Vista Health Research
Recruiting
Clintex Research Group, Inc.
Recruiting
Velocity Clinical Research - New Smyrna Beach
Recruiting
Clinical Research Solutions
Recruiting
DownTown LA Research
Recruiting
Velocity Clinical Research Greenville
Recruiting
SponsorChemo Research S.L.
Study typeInterventional
Requirements
To 75 yearsAll Gender
