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Single Blind Cross-over Dose Response Study in Subjects of Two Inhalers of Salmeterol and Fluticasone Propionate

Information source: 3M
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: salmeterol (as salmeterol xinafoate) (Drug); fluticasone propionate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: 3M

Official(s) and/or principal investigator(s):
Pui Leung, MD, Principal Investigator, Affiliation: Quotient Clinical Ltd

Summary

The purpose of this study is to test the body's response to several doses of two different inhalation products in healthy volunteers.

Clinical Details

Official title: Phase I Single Blind, Randomised, Cross-over Pharmacodynamic Dose Response Study in Healthy Volunteers of Two Pressurized Metered Dose Inhalers (pMDIs) That Deliver Salmeterol and Fluticasone Propionate

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: ECG

Secondary outcome:

plasma potassium level

plasma glucose level

Detailed description: Healthy subjects will be enrolled and will receive 2, 6, and 12 inhalations from both the test and reference pMDI products according to a six-period cross-over design. ECGs and plasma potassium and glucose levels will be measured pre-dose and over 6 hours post-dose.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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

- Male and female subjects aged 18 to 55 years (inclusive)

- 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)

- Surgery scheduled during the study or within 3 weeks after last dose

- History of familial long QT syndrome or history of sudden death in family members

aged < 30 years

Locations and Contacts

Quotient Clinical Ltd, Ruddington, Nottingham NG11 6JS, United Kingdom
Additional Information

Starting date: July 2014
Last updated: January 23, 2015

Page last updated: August 23, 2015

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