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

NCT03964207 | Completed Phase 4 Results

• 1 other identifier: 0205-0541
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 8

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®.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• PASAPQ Total Score After 4 Weeks of Treatment

  After 4 weeks of treatment (at week 4 and week 8)

• Percentage of Patients Indicating Preference at Week 8

  At Week 8.

• Overall Satisfaction Question Score From PASAPQ After 4 Weeks of Treatment

  At the end of 4 weeks of treatment

• Score on Willingness to Continue at Week 8

  At Week 8.

Study Arms (2)

(T1): 5μg tiotropium Respimat®, then (T2): 18μg tiotropium Handihaler®

EXPERIMENTAL

From Day 1 of Period 1 participants received Test treatment (T1): tiotropium Respimat® (Spiriva® Respimat®) 5 microgram (μg) once daily for a duration of 4 weeks, given as 2.5μg per puff, two puffs (2.5μg per puff) inhalation solution of tiotropium, orally via Respimat®. From Day 1 of Period 2 participants received comparator treatment(T2): tiotropium Handihaler® (Spiriva®) 18μg once daily for a duration of 4 weeks, inhalation powder tiotropium with 1 Handihaler® device.

Drug: Tiotropium Respimat® (T1); Drug: Tiotropium Handihaler® (T2)

(T2): 18μg tiotropium Handihaler®, then (T1): 5μg tiotropium Respimat®

EXPERIMENTAL

From Day 1 of Period 1 participants received comparator treatment (T2): tiotropium Handihaler® (Spiriva®) 18 microgram (μg) once daily for a duration of 4 weeks, inhalation powder tiotropium with 1 Handihaler® device. From Day 1 of Period 2 participants received Test treatment (T1): tiotropium Respimat® (Spiriva® Respimat®) 5 microgram (μg) once daily for a duration of 4 weeks, given as 2.5μg per puff, two puffs (2.5μg per puff) inhalation solution of tiotropium, orally via Respimat®.

Drug: Tiotropium Respimat® (T1); Drug: Tiotropium Handihaler® (T2)

Interventions

Tiotropium Respimat® (T1) DRUG

inhalation solution

(T1): 5μg tiotropium Respimat®, then (T2): 18μg tiotropium Handihaler®; (T2): 18μg tiotropium Handihaler®, then (T1): 5μg tiotropium Respimat®

Tiotropium Handihaler® (T2) DRUG

Inhalation Powder

(T1): 5μg tiotropium Respimat®, then (T2): 18μg tiotropium Handihaler®; (T2): 18μg tiotropium Handihaler®, then (T1): 5μg tiotropium Respimat®

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (8)

Beijing Chao-Yang Hospital

Beijing, 100020, China

Location

China-Japan Friendship Hospital

Beijing, 100029, China

Location

West China Hospital

Chengdu, 610041, China

Location

The First Afiliated Hospital, Sun Yet-sen University

Guangzhou, 510080, China

Location

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510120, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

Location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Location

The First Hospital of China Medical University

Shenyang, 110001, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 28, 2019
• Study Start: November 25, 2019
• Primary Completion: October 19, 2021
• Study Completion: November 16, 2021
• Last Updated: October 13, 2023
• Results First Posted: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

Locations

CN (8)