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Trial record 37 of 318 for:    FLUTICASONE AND SALMETEROL

Comparing Fluticasone-salmeterol in Chronic Obstructive Pulmonary Disease (COPD) and Sleep

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: NCT00731770
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Timothy Craig, Milton S. Hershey Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition COPD
Interventions Drug: Advair 250
Drug: Placebo- matched
Drug: Placebo
Drug: Advair 250 - matched
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo, Then Advair 250- Matched Advair 250, Then Palcebo- Matched
Hide Arm/Group Description 1 puff bid Placebo for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Advair 250- matched 1 puff bid for two weeks. 1 puff bid Advair 250 for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Placebo- matched 1 puff bid for two weeks.
Period Title: Overall Study
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title Placebo, Then Advair 250- Matched Advair 250, Then Placebo- Matched Total
Hide Arm/Group Description 1 puff bid Placebo for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Advair 250- matched 1 puff bid for two weeks 1 puff bid Advair 250 for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Placebo- matched 1 puff bid for two weeks Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
The PI has left the Institution and no baseline data are available for reporting. Sincere efforts were made to obtain the data, but were unsuccessful.
Age, Categorical   [1] 
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
[1]
Measure Description: data was not analyzed and is no longer available for analysis
Sex: Female, Male   [1] 
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
[1]
Measure Description: data was not analyzed and is no longer available for analysis
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants
1.Primary Outcome
Title The Aim of This Study is to Determine the Effect of Fluticasone/Salmeterol on Sleep Quality in Patients With COPD and to Compare Efficacy of Advair 250 Compared to Placebo on Sleep.
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Th PI has left the Institution and no outcome data are available for reporting. Sincere efforts were made to obtain the data, but were unsuccessful.
Arm/Group Title Placebo, Then Advair 250- Matched Advair 250, Then Palcebo- Matched
Hide Arm/Group Description:
1 puff bid Placebo for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Advair 250- matched 1 puff bid for two weeks.
1 puff bid Advair 250 for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Placebo- matched 1 puff bid for two weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Daytime Somnolence
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Th PI has left the Institution and no outcome data are available for reporting. Sincere efforts were made to obtain the data, but were unsuccessful.
Arm/Group Title Placebo, Then Advair 250- Matched Advair 250, Then Placebo- Matched
Hide Arm/Group Description:

1 puff bid Placebo for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Advair 250- matched 1 puff bid for two weeks.

Advair 250: 1 puff bid inhaled

Placebo- matched: 1 puff bid inhaled

1 puff bid Advair 250 for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Placebo- matched 1 puff bid for two weeks.

Placebo: Placebo 1 puff bid inhaled

Advair 250 - matched: i puff bid inhaled

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Advair 250
Hide Arm/Group Description 1 puff bid Placebo for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Advair 250- matched 1 puff bid for two weeks. 1 puff bid Advair 250 for two weeks followed by a 4 week washout period with placebo. After the washout period, they then received Placebo- matched 1 puff bid for two wee
All-Cause Mortality
Placebo Advair 250
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Advair 250
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Advair 250
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Th PI has left the Institution and no outcome data are available for reporting. Sincere efforts were made to obtain the data, but were unsuccessful.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Erin Banta
Organization: Penn State University
Phone: 717-531-6525 ext 1
EMail: ebanta@hmc.psu.edu
Layout table for additonal information
Responsible Party: Timothy Craig, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00731770     History of Changes
Other Study ID Numbers: IRB 29024
First Submitted: August 7, 2008
First Posted: August 11, 2008
Results First Submitted: July 17, 2017
Results First Posted: March 29, 2019
Last Update Posted: March 29, 2019