A Study on Whether Patients Prefer the Spiriva® Respimat® or the Spiriva® Handihaler® for Treating Their Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03964207
• Other study ID #: 0205-0541
• Status: Completed
• Phase: Phase 4
• Start date: November 25, 2019
• Est. completion date: November 16, 2021

Study information

• Verified date: October 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 16, 2021
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium Respimat® (T1)
inhalation solution
• Tiotropium Handihaler® (T2)
Inhalation Powder

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital	Beijing
China	China-Japan Friendship Hospital	Beijing
China	West China Hospital	Chengdu
China	First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	The First Afiliated Hospital, Sun Yet-sen University	Guangzhou
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai
China	The First Hospital of China Medical University	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance Domain of the Patient Satisfaction and Preference Questionnaire (PASAPQ) After 4 Weeks of Treatment	The score on the performance domain of the Patient satisfaction and preference questionnaire (PASAPQ) after 4 weeks of treatment is reported. The performance domain score is the sum of 7 questions (Q) within the domain (Q1, Q2, Q3, Q4, Q5, Q10 and Q11), the range for each question went from 1 to 7 the higher the better. The score was then transformed to a 0 (least) to 100 (most) point scale following ((Q1+Q2+Q3+Q4+Q5+Q10+Q11)/49)*100, the higher the better performance. The performance domain of PASAPQ) was analysed using Mixed-effects Model for Repeated Measures (MMRM), with treatment and period as fixed effects, and patient as a random effect. Compound symmetry was used as a covariance structure for within-patient variation.	After 4 weeks of treatment (at week 4 and week 8)
Secondary	PASAPQ Total Score After 4 Weeks of Treatment	The total score on the Patient satisfaction and preference questionnaire (PASAPQ) after 4 weeks of treatment is reported. The Total score is the sum of 13 questions (Q1-Q13) and then transformed to a 0 (least) to 100 (most) point scale. This continuous secondary endpoint was analyzed using a similar MMRM model as for the primary endpoint.	After 4 weeks of treatment (at week 4 and week 8)
Secondary	Percentage of Patients Indicating Preference at Week 8	The percentage of patients indicating preference in the Patient satisfaction and preference questionnaire (PASAPQ) at week 8 is reported. The questionnaire PASAPQ is a two part questionnaire, in Part II of the PASAPQ the stand-alone question 15 (Q15) was asked for a response to indicate the preference for the trial device, it had three possible answers: "I prefer Respimat", "I prefer Handihaler", "No answer to this question " and "no preference". Chi-squared test was used to analyze proportion of patients indicating preference in the Patient satisfaction and preference questionnaire (PASAPQ) at week 8.	At Week 8.
Secondary	Overall Satisfaction Question Score From PASAPQ After 4 Weeks of Treatment	The overall satisfaction question score in the Patient satisfaction and preference questionnaire (PASAPQ) at week 4 and 8 is reported (after 4 weeks of treatment). In Part I of the questionnaire PASAPQ: the Question 14 (Q14) asked for the overall satisfaction with the device used in the study. Q14 had Likert-type response options of 1 (very dissatisfied) to 7 (very satisfied) and was then transformed to a 0 (least) to 100 (most) point scale (if a patient scored "x", the transfer to 0-100 scale was x/7*100). Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the overall satisfaction question score, with treatment and period as fixed effects, and patient as a random effect.	At the end of 4 weeks of treatment
Secondary	Score on Willingness to Continue at Week 8	The score on willingness to continue in the Patient satisfaction and preference questionnaire (PASAPQ) at week 8 is reported. The PASAPQ is a two part questionnaire, in Part I of the questionnaire PASAPQ the Question 16 (Q16) asked for a response between 0 and 100 with 0 indicating not willing to continue using the trial device and 100 indicating definitely willingness to continue. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the score on willingness to continue, with treatment and period as fixed effects, and patient as a random effect.	At Week 8.

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