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CompletedNCT03964207Updated Oct 13, 2023Results posted

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

A Phase 4 interventional study of Tiotropium Respimat® (T1) and Tiotropium Handihaler® (T2) in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 8 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-13.

Sponsored by Boehringer Ingelheim · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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®.

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 72 is close to the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

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

    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)

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

    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

  • DrugTiotropium Respimat® (T1)

    inhalation solution

  • DrugTiotropium Handihaler® (T2)

    Inhalation Powder

06

What researchers measure

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.

    Time frame: After 4 weeks of treatment (at week 4 and week 8)

Secondary outcomes

  1. 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.

    Time frame: After 4 weeks of treatment (at week 4 and week 8)

  2. 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.

    Time frame: At Week 8.

  3. 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.

    Time frame: At the end of 4 weeks of treatment

  4. 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.

    Time frame: At Week 8.

07

Results

Posted Oct 13, 2023

Participant flow

This was a randomised, open-label, 2 -way cross-over design, to compare patient acceptability/preference of Tiotropium Respimat® (T1),with Tiotropium Handihaler® (T2) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

First Treatment
Participant flow — First Treatment
Milestone(T1): 5μg Tiotropium Respimat®, Then (T2): 18μg Tiotropium Handihaler®(T2): 18μg Tiotropium Handihaler®, Then (T1): 5μg Tiotropium Respimat®
Started3735
Treated3635
Completed3433
Not completed32
Withdrew: Withdrawal by subject12
Withdrew: Protocol violation10
Withdrew: Lost to follow-up10
Second Treatment
Participant flow — Second Treatment
Milestone(T1): 5μg Tiotropium Respimat®, Then (T2): 18μg Tiotropium Handihaler®(T2): 18μg Tiotropium Handihaler®, Then (T1): 5μg Tiotropium Respimat®
Started3433
Completed3330
Not completed13
Withdrew: Lost to follow-up01
Withdrew: Adverse event12

Outcome measures

PrimaryPerformance 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.

Time frame:
After 4 weeks of treatment (at week 4 and week 8)
Reported as:
Mean · Scores on a scale
Performance Domain of the Patient Satisfaction and Preference Questionnaire (PASAPQ) After 4 Weeks of Treatment
Scores on a scale(T1): 5μg Tiotropium Respimat®(T2): 18μg Tiotropium Handihaler®
Performance Domain of the Patient Satisfaction and Preference Questionnaire (PASAPQ) After 4 Weeks of Treatment79.830 ± 15.05285.112 ± 11.583
Statistical analysis
  • (T1): 5μg Tiotropium Respimat® vs (T2): 18μg Tiotropium Handihaler® · Mixed-effects Model · p = 0.007 · Difference of lsmeans: -5.28 · 95% CI -9.07 to -1.48The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.
SecondaryPASAPQ 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.

Time frame:
After 4 weeks of treatment (at week 4 and week 8)
Reported as:
Mean · Scores on a scale
PASAPQ Total Score After 4 Weeks of Treatment
Scores on a scale(T1): 5μg Tiotropium Respimat®(T2): 18μg Tiotropium Handihaler®
PASAPQ Total Score After 4 Weeks of Treatment81.51 ± 13.6785.69 ± 10.802
Statistical analysis
  • (T1): 5μg Tiotropium Respimat® vs (T2): 18μg Tiotropium Handihaler® · Mixed Models Analysis · p = 0.024 · Difference of lsmeans: -4.14 · 95% CI -7.72 to -0.56The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.
SecondaryPercentage 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.

Time frame:
At Week 8.
Reported as:
Number · Percentage
Percentage of Patients Indicating Preference at Week 8
PercentageTiotropium (T1 or T2)
I prefer Respimat50.7
I prefer Handihaler37.7
No preference5.8
No answer to this question5.8
Statistical analysis
  • Tiotropium (T1 or T2) · Chi-square test · p = 0.249 · Difference rate (%): 13.0The Difference rate was calculated as: value from the test treatment group - value from the comparator treatment group.
SecondaryOverall 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.

Time frame:
At the end of 4 weeks of treatment
Reported as:
Mean · Score on a scale
Overall Satisfaction Question Score From PASAPQ After 4 Weeks of Treatment
Score on a scale(T1): 5μg Tiotropium Respimat®(T2): 18μg Tiotropium Handihaler®
Overall Satisfaction Question Score From PASAPQ After 4 Weeks of Treatment82.56 ± 19.70287.24 ± 12.257
Statistical analysis
  • (T1): 5μg Tiotropium Respimat® vs (T2): 18μg Tiotropium Handihaler® · The mixed model for repeated measures · p = 0.057 · Difference of lsmeans: -4.72 · 95% CI -9.59 to 0.15The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.
SecondaryScore 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.

Time frame:
At Week 8.
Reported as:
Mean · Scores on a scale
Score on Willingness to Continue at Week 8
Scores on a scale(T1): 5μg Tiotropium Respimat®(T2): 18μg Tiotropium Handihaler®
Score on Willingness to Continue at Week 882.9 ± 28.1087.3 ± 19.19
Statistical analysis
  • (T1): 5μg Tiotropium Respimat® vs (T2): 18μg Tiotropium Handihaler® · Mixed Models Analysis · p = 0.347 · Difference of lsmeans: -4.38 · 95% CI -13.63 to 4.86The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.

Adverse events

Collected over From first treatment intake until 28 days after last treatment intake. Up to 56 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
(T1): 5μg Tiotropium Respimat®0/69 (0%)2/69 (2.9%)0/69 (0%)
(T2): 18μg Tiotropium Handihaler®0/69 (0%)2/69 (2.9%)0/69 (0%)
Most frequent serious events
Most frequent serious events
Event(T1): 5μg Tiotropium Respimat®(T2): 18μg Tiotropium Handihaler®
Foot deformityMusculoskeletal and connective tissue disorders0/691/69
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders1/690/69
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders1/691/69

Baseline characteristics

Treated set (TS) is defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.

Age, Continuous
Age, Continuous(Years)(T1): 5μg Tiotropium Respimat®, Then (T2): 18μg Tiotropium Handihaler®(T2): 18μg Tiotropium Handihaler®, Then (T1): 5μg Tiotropium Respimat®Total
Mean67.4 ± 6.5465.2 ± 7.2366.3 ± 6.93
Sex: Female, Male
Sex: Female, Male(Participants)(T1): 5μg Tiotropium Respimat®, Then (T2): 18μg Tiotropium Handihaler®(T2): 18μg Tiotropium Handihaler®, Then (T1): 5μg Tiotropium Respimat®Total
Female202
Male343569
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)(T1): 5μg Tiotropium Respimat®, Then (T2): 18μg Tiotropium Handihaler®(T2): 18μg Tiotropium Handihaler®, Then (T1): 5μg Tiotropium Respimat®Total
Hispanic or Latino000
Not Hispanic or Latino363571
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)(T1): 5μg Tiotropium Respimat®, Then (T2): 18μg Tiotropium Handihaler®(T2): 18μg Tiotropium Handihaler®, Then (T1): 5μg Tiotropium Respimat®Total
American Indian or Alaska Native000
Asian363571
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
08

Study locations

8 sites
  • Beijing Chao-Yang Hospital
    Beijing, 100020, China
  • China-Japan Friendship Hospital
    Beijing, 100029, China
  • West China Hospital
    Chengdu, 610041, China
  • The First Afiliated Hospital, Sun Yet-sen University
    Guangzhou, 510080, China
  • First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, 510120, China
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, 200025, China
  • Zhongshan Hospital Fudan University
    Shanghai, 200032, China
  • The First Hospital of China Medical University
    Shenyang, 110001, China
09

References and documents

Related links

Study documents

  • Study protocol · Mar 23, 2020
  • Statistical analysis plan · Jul 14, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03964207
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
May 28, 2019
Start date
Nov 25, 2019
Primary completion
Oct 19, 2021
Completion
Nov 16, 2021
Results posted
Oct 13, 2023
Last update
Oct 13, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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