Clinical trial NCT03964207: A Study on Whether Patients Prefer the Spiriva® Respimat® or the Spiriva® Handihaler® for Treating Their Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized, Open-label, Two-way Crossover Study to Compare Patient Acceptability/Preference of Tiotropium Respimat® With Tiotropium Handihaler® in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-05-28
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the patient acceptability/preference of Respimat® compared with Handihaler® in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) to demonstrate the superiority of Respimat®.


Eligibility criteria: Inclusion Criteria:

* All patients must have a diagnosis of COPD and must meet the following spirometric criteria at Visit 1 (Screening).

  * Relatively stable, moderate to very severe airway obstruction with a post-bronchodilator FEV1 \<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 = exp \[-10.61669 + 2.27078 × ln (- in cm) + 0.06622 × ln (age in year) + Mspline\] Female = exp \[-9.69716 + 2.09385 × ln (- in cm) + 0.02006 × ln (age in year) + Mspline\]
  * Historical data from spirometry measurements within the past 6 either at the site or at the other hospital may be used. If the measurements are not performed at the trial site a referral letter and signed copies of the measurement printouts must be provided to the trial site for source data verification. In case several qualifying spirometry measurements are available, the most recent one should be referred to as long as it was not performed during an exacerbation. Patients may not be randomised to the study without the availability of spirometry data at the actual study site.
* Male or female, age: ≥40 years of age
* 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

Exclusion Criteria:

* 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 had used both Respimat® and HandiHaler® (including generic HandiHaler®) within one year prior 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 malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed).
* Known active tuberculosis.
* Patients with a history of asthma, cystic fibrosis, clinically not well-controlled 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.

Primary outcomes:
measure: Performance Domain of the Patient Satisfaction and Preference Questionnaire (PASAPQ) After 4 Weeks of Treatment
timeFrame: After 4 weeks of treatment (at week 4 and week 8)
Secondary outcomes:
measure: PASAPQ Total Score After 4 Weeks of Treatment
timeFrame: After 4 weeks of treatment (at week 4 and week 8)
measure: Percentage of Patients Indicating Preference at Week 8
timeFrame: At Week 8.
measure: Overall Satisfaction Question Score From PASAPQ After 4 Weeks of Treatment
timeFrame: At the end of 4 weeks of treatment
measure: Score on Willingness to Continue at Week 8
timeFrame: At Week 8.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Chengdu
country: China
facility: West China Hospital
city: Guangzhou
country: China
facility: The First Afiliated Hospital, Sun Yet-sen University
city: Guangzhou
country: China
facility: First Affiliated Hospital of Guangzhou Medical University
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shenyang
country: China
facility: The First Hospital of China Medical University
Study officials:
References: