Clinical trial NCT02232087: Single Blind Cross-over Dose Response Study in Subjects of Two Inhalers of Salmeterol and Fluticasone Propionate
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: long-acting beta agonist (LABA)
corticosteroid
pMDI
inhaler
Lead sponsor: Kindeva Drug Delivery
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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. Electrocardiograms (ECGs) and plasma potassium and glucose levels will be measured pre-dose and over 6 hours post-dose.

Eligibility 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

Primary outcomes:
measure: Relative Potency Max Heart Rate
timeFrame: Baseline, up to 6 hrs
measure: Relative Potency QTcB Interval
timeFrame: Baseline up to 6 hrs
Secondary outcomes:
measure: Max Heart Rate
timeFrame: Baseline through 6 hours
measure: Plasma Potassium Level
timeFrame: baseline through 6 hours
measure: Max Plasma Glucose Level
timeFrame: baseline through 6 hours
measure: Max QTcB
timeFrame: Baseline through 6 hours
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Clinical Ltd
state: Nottingham
Study officials:
affiliation: Quotient Clinical Ltd
name: Pui Leung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harrison LI, Sessions V, Wiggenhorn CJ, Chalmers D, Leung P, Efthimiou J. Comparison of systemic pharmacodynamic effects of two combination pressurized metered dose inhalers that deliver salmeterol and fluticasone propionate. Br J Clin Pharmacol. 2017 Nov;83(11):2377-2385. doi: 10.1111/bcp.13349. Epub 2017 Aug 1.