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

NCT02232087 | Completed Phase 1 Results DMC

• 1 other identifier: DDSD-1030-SAFL
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

long-acting beta agonist (LABA); corticosteroid; pMDI; inhaler

Outcome Measures

Primary Outcomes (2)

• Relative Potency Max Heart Rate

  Selection of steepest part of dose response curve for Relative Potency: 6 and 12 inhalation dose pairs. Slope of B and C line compared with slope of E and F to obtain relative potency value. Two inhalation dose not utilized as not on steepest part of curve.

  Baseline, up to 6 hrs

• Relative Potency QTcB Interval

  Selection of steepest part of dose response curve for Relative Potency: 2 and 6 inhalation dose pairs. Slope of A and B line compared with slope of D and E to obtain relative potency value. Twelve inhalation dose not utilized as not on steepest part of curve.

  Baseline up to 6 hrs

Secondary Outcomes (4)

• Max Heart Rate

  Baseline through 6 hours

• Plasma Potassium Level

  baseline through 6 hours

• Max Plasma Glucose Level

  baseline through 6 hours

• Max QTcB

  Baseline through 6 hours

Study Arms (6)

test product A

EXPERIMENTAL

salmeterol and fluticasone propionate, 2 puffs

Drug: Salmeterol; Drug: fluticasone propionate

reference product D

ACTIVE COMPARATOR

salmeterol and fluticasone propionate, 2 puffs

Drug: Salmeterol; Drug: fluticasone propionate

test product B

EXPERIMENTAL

salmeterol and fluticasone propionate, 6 puffs

Drug: Salmeterol; Drug: fluticasone propionate

reference product E

ACTIVE COMPARATOR

salmeterol and fluticasone propionate, 6 puffs

Drug: Salmeterol; Drug: fluticasone propionate

test product C

EXPERIMENTAL

salmeterol and fluticasone propionate, 12 puffs

Drug: Salmeterol; Drug: fluticasone propionate

reference product F

ACTIVE COMPARATOR

salmeterol and fluticasone propionate, 12 puffs

Drug: Salmeterol; Drug: fluticasone propionate

Interventions

Salmeterol DRUG

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

Also known as: Sirdupla, Seretide Evohaler

reference product D; reference product E; reference product F; test product A; test product B; test product C

fluticasone propionate DRUG

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

Also known as: Sirdupla, Seretide Evohaler

reference product D; reference product E; reference product F; test product A; test product B; test product C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kindeva Drug Delivery: lead

Study Sites (1)

Quotient Clinical Ltd

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28626983 RESULT

MeSH Terms

Interventions

Salmeterol Xinafoate; Fluticasone

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

There are no limitations or caveats.

Results Point of Contact

• Title: Pui Leung
• Organization: Quotient Clinical Ltd

Pui Leung <Pui.Leung@quotientclinical.com>

44(0)115 974 9000

Study Officials

• Pui Leung, MD

  Quotient Clinical Ltd

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 4, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 15, 2022
• Results First Posted: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)