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Trial record 85 of 318 for:    FLUTICASONE AND SALMETEROL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02232087
Recruitment Status : Completed
First Posted : September 4, 2014
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
3M

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: salmeterol (as salmeterol xinafoate) Drug: fluticasone propionate Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: test product
salmeterol and fluticasone propionate
Drug: salmeterol (as salmeterol xinafoate)
2, 6, and 12 inhalations
Other Name: Seretide Evohaler

Drug: fluticasone propionate
2, 6, and 12 inhalations
Other Name: Seretide Evohaler

Active Comparator: reference product
salmeterol and fluticasone propionate
Drug: salmeterol (as salmeterol xinafoate)
2, 6, and 12 inhalations
Other Name: Seretide Evohaler

Drug: fluticasone propionate
2, 6, and 12 inhalations
Other Name: Seretide Evohaler




Primary Outcome Measures :
  1. ECG [ Time Frame: 6 hours ]
    data adjusted for change from baseline


Secondary Outcome Measures :
  1. plasma potassium level [ Time Frame: 6 hours ]
    change from baseline levels of potassium will be compared

  2. plasma glucose level [ Time Frame: 6 hours ]
    change from baseline levels of glucose will be compared



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232087


Locations
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United Kingdom
Quotient Clinical Ltd
Ruddington, Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
3M
Investigators
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Principal Investigator: Pui Leung, MD Quotient Clinical Ltd

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Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT02232087     History of Changes
Other Study ID Numbers: DDSD-1030-SAFL
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015
Keywords provided by 3M:
long-acting beta agonist (LABA)
corticosteroid
pMDI
inhaler
Additional relevant MeSH terms:
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Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics