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

NCT ID: NCT02232087

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

test product A

salmeterol and fluticasone propionate, 2 puffs

Group Type: EXPERIMENTAL

Salmeterol

Intervention Type: DRUG

A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

fluticasone propionate

Intervention Type: DRUG

A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

reference product D

salmeterol and fluticasone propionate, 2 puffs

Group Type: ACTIVE_COMPARATOR

Salmeterol

Intervention Type: DRUG

A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

fluticasone propionate

Intervention Type: DRUG

A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

test product B

salmeterol and fluticasone propionate, 6 puffs

Group Type: EXPERIMENTAL

Salmeterol

Intervention Type: DRUG

A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

fluticasone propionate

Intervention Type: DRUG

A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

reference product E

salmeterol and fluticasone propionate, 6 puffs

Group Type: ACTIVE_COMPARATOR

Salmeterol

Intervention Type: DRUG

A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

fluticasone propionate

Intervention Type: DRUG

A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

test product C

salmeterol and fluticasone propionate, 12 puffs

Group Type: EXPERIMENTAL

Salmeterol

Intervention Type: DRUG

A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

fluticasone propionate

Intervention Type: DRUG

A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

reference product F

salmeterol and fluticasone propionate, 12 puffs

Group Type: ACTIVE_COMPARATOR

Salmeterol

Intervention Type: DRUG

A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

fluticasone propionate

Intervention Type: DRUG

A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

Interventions

Salmeterol

A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

Intervention Type: DRUG

fluticasone propionate

A, D 2 puffs; B, E 6 puffs; C, F 12 puffs

Intervention Type: DRUG

Other Intervention Names

Sirdupla; Seretide Evohaler; Sirdupla; Seretide Evohaler

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kindeva Drug Delivery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pui Leung, MD

Role: PRINCIPAL_INVESTIGATOR

Quotient Clinical Ltd

Locations

Quotient Clinical Ltd

Ruddington, Nottingham, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 28626983 (View on PubMed)

Other Identifiers

DDSD-1030-SAFL

Identifier Type: -

Identifier Source: org_study_id