FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects
![]() |
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: NCT00370097 |
Recruitment Status
:
Completed
First Posted
: August 30, 2006
Last Update Posted
: September 11, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: FLOVENT (fluticasone propionate) HFA Drug: Placebo HFA | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | PD of Hydrofluoroalkane Propellant of Inhaled Fluticasone Propionate Following Administration in Pediatric Subjects 6-12 Months of Age With Asthma |
Actual Study Start Date : | August 30, 2006 |
Actual Primary Completion Date : | April 12, 2007 |
Actual Study Completion Date : | April 12, 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Subjects receiving HFA
Subjects in Session 1 will receive two inhalations of placebo HFA by meter-dose inhaler (MDI) twice daily and in Session 2 subjects will receive two inhalations of fluticasone propionate (FP) HFA MDI 44 mcg twice daily
|
Drug: FLOVENT (fluticasone propionate) HFA
FLOVENT HFA consists of a white to off-white suspension of FP (micronized) in a liquefied hydrofluoroalkane propellant, 1,1,1,2-tetrafluoroethane. Subject will receive FP HFA using an Aerochamber Plus with Infant Mask.
Drug: Placebo HFA
Subjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask.
|
- Serum cortisol weighted mean(0-12h) [ Time Frame: throughout the study ]
- Serum cortisol Cmin FP Cmaxss, AUClast and tmaxss Adverse events [ Time Frame: throughout the study ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Months to 12 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects who have experienced 2 or more wheezing episodes in the previous 6 months.
- Subjects may not have taken any corticosteroids in the 4 weeks prior to dosing
- Parents/guardians should be able to read and comprehend diary information collected throughout the study
- Parents must be able to demonstrate the ability to use the facemask and spacer used to administer study drug
Exclusion criteria:
- Subjects who weigh less than 7 kg
- Subjects who are taking any drugs that inhibit or induce the cytochrome P450 isoform
- Any parents who have a history of psychiatric disease, intellectual deficiency, substance abuse that would compromise the validity of the consent

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): NCT00370097
United States, California | |
GSK Investigational Site | |
Huntington Beach, California, United States, 92647 | |
United States, Colorado | |
GSK Investigational Site | |
Centennial, Colorado, United States, 80112 | |
United States, Florida | |
GSK Investigational Site | |
Jacksonville, Florida, United States, 32207 | |
United States, Georgia | |
GSK Investigational Site | |
Atlanta, Georgia, United States, 30309-7520 | |
United States, Illinois | |
GSK Investigational Site | |
Normal, Illinois, United States, 61761 | |
United States, Oklahoma | |
GSK Investigational Site | |
Oklahoma City, Oklahoma, United States, 73112 | |
United States, Texas | |
GSK Investigational Site | |
Dallas, Texas, United States, 75230 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00370097 History of Changes |
Other Study ID Numbers: |
FAS106533 |
First Posted: | August 30, 2006 Key Record Dates |
Last Update Posted: | September 11, 2017 |
Last Verified: | September 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
URL: | http:// |
Keywords provided by GlaxoSmithKline:
Asthma infants FLOVENT spacer |
Additional relevant MeSH terms:
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone |
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 |