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Anticholinergic

Test Product (tiotropium bromide inhalation powder) for Chronic Obstructive Pulmonary Disease

Phase 3
Waitlist Available
Research Sponsored by Lupin, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-24 hours after dosing on day 1 of visits 2-4 over a period of approximately 6 weeks
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

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).

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-24 hours after dosing on day 1 of visits 2-4 over a period of approximately 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-24 hours after dosing on day 1 of visits 2-4 over a period of approximately 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Baseline Adjusted Mean Change in FEV1 AUC0-24h Post Dose
Difference in Baseline Adjusted FEV1 AUC0-24h for Comparison of Lupin Tiotropium Bromide Inhalation Powder (Test) and Spiriva (Reference) to Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Test Product (tiotropium bromide inhalation powder)Experimental Treatment1 Intervention
Once daily administration of test product (tiotropium bromide inhalation powder), 18 mcg for open-label extension (device robustness).
Group II: Reference Product (Spiriva®)Active Control1 Intervention
Single dose of reference product (Spiriva®) 18 mcg
Group III: PlaceboPlacebo Group1 Intervention
Single dose of placebo inhalation powder
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tiotropium
FDA approved

Find a Location

Who is running the clinical trial?

Lupin, Inc.Lead Sponsor
1 Previous Clinical Trials
217 Total Patients Enrolled
~47 spots leftby Dec 2025
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