Phase 3
Completed N=374
Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness
Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov NCT03137992 ↗
Enrolled (actual)
374
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Baseline Adjusted Mean Change in FEV1 AUC0-24h Post Dose — 2.5644; 2.7370 L*hour
Summary
The purpose of this study is to show bioequivalence of test product to reference product based on baseline-adjusted forced expiratory volume in one second (FEV1).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Adjusted Mean Change in FEV1 AUC0-24h Post Dose |
2.5644; 2.7370 | — |
| PRIMARY Difference in Baseline Adjusted FEV1 AUC0-24h for Comparison of Lupin Tiotropium Bromide Inhalation Powder (Test) and Spiriva (Reference) to Placebo |
2.90; 3.03; -0.40 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Male and non-pregnant female subjects (40 years of age and older).
- Patients with diagnosis of COPD according to the GOLD guidelines.
- Post-bronchodilator FEV1 <80% of the predicted value at the screening visit.
- Post-bronchodilator FEV1/FVC ratio ≤0.70 at the screening visit.
- Current or former smokers (e.g., with history of = 10 pack-years).
- Written informed consent.
Exclusion Criteria
- Known respiratory disorder other than COPD including, but not limited to the following: alpha-1 antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease.
- History of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or known hypersensitivity to any of the proposed ingredients or components of the delivery system.
- Hospitalization for COPD or pneumonia within 12 weeks prior to the screening visit.
- Treatment for COPD exacerbation within 12 weeks prior to the screening visit.
- Viral or bacterial upper or lower respiratory tract infection, sinusitis, sinus infection, rhinitis, pharyngitis, middle ear infection, urinary tract infection, or illness within 6 weeks prior to the screening visit.
- Abnormal and significant ECG finding prior to the screening, during the run-in and treatment periods.
Data sourced from ClinicalTrials.gov (NCT03137992). 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. Informational only — not medical advice.