Phase 4
N=72
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
Bottom Line
View on ClinicalTrials.gov: NCT03964207 ↗Enrolled (actual)
72
Serious AEs
2.9%
Results posted
Oct 2023
Primary outcome: Primary: Performance Domain of the Patient Satisfaction and Preference Questionnaire (PASAPQ) After 4 Weeks of Treatment — 79.830; 85.112 Scores on a scale — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tiotropium Respimat® (T1) (Drug); Tiotropium Handihaler® (T2) (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance Domain of the Patient Satisfaction and Preference Questionnaire (PASAPQ) After 4 Weeks of Treatment |
79.830; 85.112 | 0.007 sig |
| SECONDARY PASAPQ Total Score After 4 Weeks of Treatment |
81.51; 85.69 | 0.024 sig |
| SECONDARY Percentage of Patients Indicating Preference at Week 8 |
50.7; 37.7; 5.8; 5.8 | 0.249 |
| SECONDARY Overall Satisfaction Question Score From PASAPQ After 4 Weeks of Treatment |
82.56; 87.24 | 0.057 |
| SECONDARY Score on Willingness to Continue at Week 8 |
82.9; 87.3 | 0.347 |
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 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.
Data sourced from ClinicalTrials.gov (NCT03964207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.