Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 76 of 318 for:    FLUTICASONE AND SALMETEROL

Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair

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: NCT00927758
Recruitment Status : Completed
First Posted : June 25, 2009
Results First Posted : September 8, 2014
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Sandoz

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Intervention Drug: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg
Enrollment 105
Recruitment Details  
Pre-assignment Details Actual screened patients was 105. However, 22 eligible patients were randomized.
Arm/Group Title Sequence 1: Flu/Sal- 250mcg/50mcg ->100mcg/50mcg->500mcg/50mcg Sequence 2: Flu/Sal- 500mcg/50mcg ->250mcg/50mcg->100mcg/50mcg Sequence 3: Flu/Sal- 100mcg/50mcg ->250mcg/50mcg->500mcg/50mcg Sequence 4: Flu/Sal- 250mcg/50mcg ->500mcg/50mcg->100mcg/50mcg Sequence 5: Flu/Sal- 500mcg/50mcg ->100mcg/50mcg->250mcg/50mcg Sequence 6: Flu/Sal- 100mcg/50mcg ->500mcg/50mcg->250mcg/50mcg
Hide Arm/Group Description

Treatment cycle 1: Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for

7 days.

Treatement Cycle 2 : Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for

7 days.

Treatment Cycle 3: Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for

7 days.

There were 14 days washout period between cycles.

Treatment cycle 1: Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for

7 days.

Treatement Cycle 2 : Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for

7 days.

Treatment Cycle 3: Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for

7 days.

There were 14 days washout period between cycles.

Treatment cycle 1: Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for

7 days.

Treatement Cycle 2 : Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for

7 days.

Treatment Cycle 3: Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for

7 days.

There were 14 days washout period between cycles.

Treatment cycle 1: Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for

7 days.

Treatement Cycle 2 : Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for

7 days.

Treatment Cycle 3: Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for

7 days.

There were 14 days washout period between cycles.

Treatment cycle 1: Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for

7 days.

Treatement Cycle 2 : Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for

7 days.

Treatment Cycle 3: Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for

7 days.

There were 14 days washout period between cycles.

Treatment cycle 1: Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for

7 days.

Treatement Cycle 2 : Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for

7 days.

Treatment Cycle 3: Patient randomized to Fluticasone

Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for

7 days.

There were 14 days washout period between cycles.

Period Title: Treatment Cycle 1 (Day 1 - Day 7)
Started 4 [1] 4 4 3 3 4
Intent to Treat (ITT) 4 4 4 2 3 3
Completed 4 4 4 2 3 3
Not Completed 0 0 0 1 0 1
Reason Not Completed
Withdrawal by Subject             0             0             0             1             0             1
[1]
"Started " indicates randomized as well as safety set.
Period Title: Treatment Cycle 2 (Day 1 - Day 7)
Started 4 4 4 2 3 3
Per Protocol Population (PP) 4 4 3 1 3 2
Completed 4 4 3 1 3 2
Not Completed 0 0 1 1 0 1
Reason Not Completed
Did not meet eNO criteria             0             0             1             1             0             1
Period Title: Treatment Cycle 3 (Day 1 - Day 7)
Started 4 4 3 1 3 2
Completed 4 4 3 1 3 2
Not Completed 0 0 0 0 0 0
Arm/Group Title All Randomized Patients
Hide Arm/Group Description Baseline measured for all randomized (safety set) patients.
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
29.86  (10.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
11
  50.0%
Male
11
  50.0%
1.Primary Outcome
Title Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)
Hide Description Percentage change in eNO was reported following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines. eNO was calculated 3 times every day in a treatment cycle for 7 days. The maximum value of all 3 collected value were collected for each seven days of the individual treatment cycle. Out of the maximum values, the minimum was taken and used for calculating the percentage change from baseline.
Time Frame Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol (PP) population was all subjects who completed the study with no major variances that would impair the analysis of the data
Arm/Group Title Flu/Sal- 100mcg/50mcg Flu/Sal- 250mcg/50mcg Flu/Sal- 500mcg/50mcg
Hide Arm/Group Description:
All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
Overall Number of Participants Analyzed 17 17 17
Mean (Standard Deviation)
Unit of Measure: Percentage change in eNO
36.65  (18.74) 45.31  (16.46) 54.58  (12.55)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety set includes all subjects who received at least one dose of drug.
 
Arm/Group Title Flu/Sal- 100mcg/50mcg Flu/Sal- 250mcg/50mcg Flu/Sal- 500mcg/50mcg
Hide Arm/Group Description All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days. All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days. All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
All-Cause Mortality
Flu/Sal- 100mcg/50mcg Flu/Sal- 250mcg/50mcg Flu/Sal- 500mcg/50mcg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Flu/Sal- 100mcg/50mcg Flu/Sal- 250mcg/50mcg Flu/Sal- 500mcg/50mcg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%)   1/17 (5.88%) 
Injury, poisoning and procedural complications       
Injury  1  0/20 (0.00%)  0/19 (0.00%)  1/17 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Flu/Sal- 100mcg/50mcg Flu/Sal- 250mcg/50mcg Flu/Sal- 500mcg/50mcg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/20 (15.00%)   1/19 (5.26%)   5/17 (29.41%) 
Eye disorders       
Dilated, Dry Eyes  1  0/20 (0.00%)  1/19 (5.26%)  0/17 (0.00%) 
Gastrointestinal disorders       
Vomiting  1  0/20 (0.00%)  0/19 (0.00%)  1/17 (5.88%) 
Infections and infestations       
Viral Upper respiratory infection  1  1/20 (5.00%)  0/19 (0.00%)  0/17 (0.00%) 
Upper Respiratory infection  1  1/20 (5.00%)  0/19 (0.00%)  3/17 (17.65%) 
Respiratory, thoracic and mediastinal disorders       
Worsening Asthma  1  0/20 (0.00%)  0/19 (0.00%)  2/17 (11.76%) 
Oropharyngeal pain  1  0/20 (0.00%)  0/19 (0.00%)  1/17 (5.88%) 
Cough  1  1/20 (5.00%)  0/19 (0.00%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The terms and conditions of Sandoz's agreements with its investigators may vary. However, Sandoz does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Sandoz
Phone: 609-627-8889
EMail: yaping.zhu@sandoz.com
Layout table for additonal information
Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT00927758     History of Changes
Other Study ID Numbers: CP-Sandoz-2009-PilotFP
First Submitted: June 23, 2009
First Posted: June 25, 2009
Results First Submitted: April 22, 2014
Results First Posted: September 8, 2014
Last Update Posted: March 29, 2017