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

Kindeva

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Salmeterol; Drug: fluticasone propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02232087

DDSD-1030-SAFL

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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52 participants in 6 patient groups

test product A

Experimental group

Description:

salmeterol and fluticasone propionate, 2 puffs

Treatment:

Drug: fluticasone propionate

Drug: Salmeterol

reference product D

Active Comparator group

Description:

salmeterol and fluticasone propionate, 2 puffs

Treatment:

Drug: fluticasone propionate

Drug: Salmeterol

test product B

Experimental group

Description:

salmeterol and fluticasone propionate, 6 puffs

Treatment:

Drug: fluticasone propionate

Drug: Salmeterol

reference product E

Active Comparator group

Description:

salmeterol and fluticasone propionate, 6 puffs

Treatment:

Drug: fluticasone propionate

Drug: Salmeterol

test product C

Experimental group

Description:

salmeterol and fluticasone propionate, 12 puffs

Treatment:

Drug: fluticasone propionate

Drug: Salmeterol

reference product F

Active Comparator group

Description:

salmeterol and fluticasone propionate, 12 puffs

Treatment:

Drug: fluticasone propionate

Drug: Salmeterol