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 levelplasma 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
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