Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference Product

Phase I Randomised, Five-period Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Four Test pMDI Products With Spiriva Respimat

The purpose of this study is to compare the absorption of four different inhalation products with the reference product in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: tiotropium pMDI

Detailed Description

Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products and one reference inhalation product according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Loughborough, United Kingdom
    • 3M Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy Volunteer
• Willing and able to give informed consent
• Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
• Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration

Exclusion Criteria:

• Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
• Any presence or history of a clinically significant allergy including any adverse reaction to study drug
• History of drug or alcohol abuse within the past 2 years
• Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
• Donation or loss of greater than 400 mL of blood within the previous 3 months
• Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)
• Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)
• Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
• If female, nursing, lactating or pregnant
• Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Product 1; tiotropium pMDI 2 inhalations	Drug: tiotropium pMDI; inhalation; Other Names: Spiriva Respimat
Experimental: Test Product 2; tiotropium pMDI 2 inhalations	Drug: tiotropium pMDI; inhalation; Other Names: Spiriva Respimat
Experimental: Test Product 3; tiotropium pMDI 2 inhalations	Drug: tiotropium pMDI; inhalation; Other Names: Spiriva Respimat
Experimental: Test Product 4; tiotropium pMDI 2 inhalations	Drug: tiotropium pMDI; inhalation; Other Names: Spiriva Respimat
Active Comparator: Commercial Product; tiotropium Respimat 2 inhalations	Drug: tiotropium pMDI; inhalation; Other Names: Spiriva Respimat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	noncompartmental analysis	24 hr

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	reported adverse events	24 hr
Area Under the Plasma Concentration vs Time Curve (AUC)	trapezoidal rule	24 hr

Collaborators and Investigators

• Sponsor: Solventum US LLC
• Collaborators: 3M
• Investigators: Study Chair: Victoria Sessions, PhD, 3M

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2017
• Primary Completion (Actual): January 21, 2018
• Study Completion (Actual): March 19, 2018

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: corticosteroid; inhalation; LABA
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Cholinergic Antagonists; Cholinergic Agents; Parasympatholytics; Tiotropium Bromide
• Other Study ID Numbers: CSP-07-000039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No