Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 86 of 319 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

Tracking Information
First Submitted Date  ICMJE September 2, 2014
First Posted Date  ICMJE September 4, 2014
Last Update Posted Date January 26, 2015
Study Start Date  ICMJE July 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2014)
ECG [ Time Frame: 6 hours ]
data adjusted for change from baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02232087 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2014)
  • plasma potassium level [ Time Frame: 6 hours ]
    change from baseline levels of potassium will be compared
  • plasma glucose level [ Time Frame: 6 hours ]
    change from baseline levels of glucose will be compared
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Blind Cross-over Dose Response Study in Subjects of Two Inhalers of Salmeterol and Fluticasone Propionate
Official Title  ICMJE 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
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. ECGs and plasma potassium and glucose levels will be measured pre-dose and over 6 hours post-dose.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: test product
    salmeterol and fluticasone propionate
    Interventions:
    • Drug: salmeterol (as salmeterol xinafoate)
    • Drug: fluticasone propionate
  • Active Comparator: reference product
    salmeterol and fluticasone propionate
    Interventions:
    • Drug: salmeterol (as salmeterol xinafoate)
    • Drug: fluticasone propionate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2015)
52
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2014)
48
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02232087
Other Study ID Numbers  ICMJE DDSD-1030-SAFL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party 3M
Study Sponsor  ICMJE 3M
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pui Leung, MD Quotient Clinical Ltd
PRS Account 3M
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP