The objective of this study is to investigate the patient acceptability/preference of Respimat® compared with Handihaler® in patients with moderate to severe chronic obstructive pulmonary disease (COPD) to demonstrate the superiority of Respimat®.
Full Title of Study: “A Randomized, Open-label, Two-way Crossover Study to Compare Patient Acceptability/Preference of Tiotropium Respimat® With Tiotropium Handihaler® in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 6, 2020
- Drug: Tiotropium Respimat® (T1)
- inhalation solution
- Drug: Tiotropium Handihaler® (T2)
- Inhalation Powder
Arms, Groups and Cohorts
- Experimental: T1 followed by T2
- Experimental: T2 followed by T1
Clinical Trial Outcome Measures
- Performance domain of the Patient satisfaction and preference questionnaire (PASAPQ)
- Time Frame: Week 4
- PASAPQ total score
- Time Frame: Week 4
- Proportion of patients indicating preference
- Time Frame: Week 8
- Overall Satisfaction Question Score from PASAPQ
- Time Frame: Week 4 & Week 8
- Score on willingness to continue
- Time Frame: Week 8
- Response between 0 and 100 with 0 indicating not willing to continue using the trial device and 100 indicating definitely willing to continue.
Participating in This Clinical Trial
- All patients must have a diagnosis of COPD and must meet the following spirometric criteria at Visit 1 (Screening).
– Relatively stable, moderate to severe airway obstruction with a post-bronchodilator 30% ≤ Forced Expiratory Volume (FEV)1 ≤80% of predicted normal and FEV1/FVC ≤70%. Spirometry should be done at baseline and approximately 1/2 hour following 4 inhalations of albuterol.
- Male or female, age: 40-80 years
- Patients must be current or ex-smokers with a smoking history of ≥ 10 pack years. (Patients who have never smoked cigarettes must be excluded).
- Signed and dated written informed consent in accordance with International Council on Harmonization (ICH) ICH-GCP and local legislation prior to admission to the trial
- Patients must be able to inhale medication from the Tiotropium Respimat® and Tiotropium HandiHaler®
- Patients must be able to perform all study related procedures, and must be able to maintain records (patient diary) during the study period as required by the protocol
- Had visual, cognitive, or motor impairment that, as judged by the investigator, did not allow the patient to independently read and complete the PASAPQ questionnaire
- Patients have any previous experience of using Respimat® or Handihaler® or generic Handihaler within one year pior to screening.
- Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patients at risk because of participation in the study or may influence either the results of the study or the patient's ability to participate in the study.
- All patients with an Aspartate Transaminase (AST) (serum glutamic-oxaloacetic transaminase, SGOT) >80 IU/L, Alanine Aminotransferase (ALT) (Serum Glutamic-pyruvic Transaminase, SGPT) >80 IU/L, Bilirubin >2.0 mg/dL or Creatinine >2.0 mg/dL will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not be conducted in these subjects.
- Patients with a recent history (i.e., one year or less) of myocardial infarction.
- Patients who have been hospitalized or being treated for heart failure within the past year.
- Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
- Patients with a history of cancer, other than treated basal cell carcinoma, within the last five years.
- Known active tuberculosis.
- Patients with a history of asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease
- History of thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated.
- Patients with any respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial screening visit (Visit 1).
- Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction. Patients whose symptoms are controlled on treatment may be included.
- Patients with known narrow-angle glaucoma
- Use of systemic corticosteroid medication at unstable doses (i.e., less than six weeks on stable dose) or at doses in excess of the equivalent of 10 milligrams (mg) prednisolone per day.
- Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy.
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral or injectable contraceptives, intrauterine devices (IUD) or diaphragm with spermicide, or Norplant®).
- Significant alcohol or drug abuse within the past 12 months
- Known hypersensitivity to anticholinergic drugs, lactose, benzalkonium chloride (BAC), ethylenediaminetetraacetic acid (EDTA) or any other components of the HandiHaler® or Respimat® inhalation solution delivery system.
- Patients currently in any pulmonary rehabilitation program or scheduled to participate in any such program during the study period.
- Previous participation in this study. (The patient cannot re-enroll into this study.)
- Patients who are currently participating in another interventional study.
Gender Eligibility: All
Minimum Age: 40 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Boehringer Ingelheim
- Provider of Information About this Clinical Study
- Overall Contact(s)
- Boehringer Ingelheim, 1-800-243-0127, email@example.com
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