Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness

Lupin

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Test Product (tiotropium bromide inhalation powder); Drug: Reference Product (Spiriva®); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03137992

TB-DPI-301

Details and patient eligibility

About

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).

Enrollment: 377 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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377 participants in 3 patient groups, including a placebo group

Test Product (tiotropium bromide inhalation powder)

Experimental group

Description:

Once daily administration of test product (tiotropium bromide inhalation powder), 18 mcg for open-label extension (device robustness).

Treatment:

Drug: Test Product (tiotropium bromide inhalation powder)

Reference Product (Spiriva®)

Active Comparator group

Description:

Single dose of reference product (Spiriva®) 18 mcg

Treatment:

Drug: Reference Product (Spiriva®)

Placebo

Placebo Comparator group

Description:

Single dose of placebo inhalation powder

Treatment:

Drug: Placebo