Trial Outcomes & Findings for Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects (NCT NCT00517634)
NCT ID: NCT00517634
Last Updated: 2016-12-16
Results Overview
Number of peripheral blood eosinophils measured from blood draws
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35
Results posted on
2016-12-16
Participant Flow
Participant milestones
| Measure |
Sequence 1: FP, SFC, Placebo
Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period
|
Sequence 2: Placebo, SFC, FP
Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
|
Sequence 3: SFC, FP, Placebo
Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period
|
Sequence 4: SFC, Placebo, FP
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
|
Sequence 5: FP, Placebo, SFC
Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
|
Sequence 6: Placebo, FP, SFC
Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
|
|---|---|---|---|---|---|---|
|
First Treatment Period
STARTED
|
4
|
4
|
4
|
3
|
4
|
4
|
|
First Treatment Period
COMPLETED
|
4
|
4
|
4
|
3
|
4
|
4
|
|
First Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Treatment Period
STARTED
|
4
|
4
|
4
|
3
|
4
|
4
|
|
Second Treatment Period
COMPLETED
|
4
|
4
|
4
|
3
|
3
|
4
|
|
Second Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Third Treatment Period
STARTED
|
4
|
4
|
4
|
3
|
3
|
4
|
|
Third Treatment Period
COMPLETED
|
4
|
4
|
4
|
3
|
3
|
4
|
|
Third Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: FP, SFC, Placebo
Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period
|
Sequence 2: Placebo, SFC, FP
Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
|
Sequence 3: SFC, FP, Placebo
Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period
|
Sequence 4: SFC, Placebo, FP
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
|
Sequence 5: FP, Placebo, SFC
Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
|
Sequence 6: Placebo, FP, SFC
Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
|
|---|---|---|---|---|---|---|
|
Second Treatment Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=23 Participants
Overall Study Population: participants in all three treatment periods
|
|---|---|
|
Age, Continuous
|
36.6 years
STANDARD_DEVIATION 6.63 • n=5 Participants
|
|
Gender
Female
|
9 Participants
n=5 Participants
|
|
Gender
Male
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35Population: Intent-to-Treat (ITT) Population: All participants receiving at least one dose of study medication who had at least one post-randomization efficacy assessment
Number of peripheral blood eosinophils measured from blood draws
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo
|
FP 100 mcg BID
n=22 Participants
Fluticasone Propionate (FP) 100 mcg BID
|
SFC 50/100 mcg BID
n=22 Participants
Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID
|
|---|---|---|---|
|
Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35
|
-0.050 Giga Units per Liter (GI/L)
Interval -0.072 to -0.029
|
-0.040 Giga Units per Liter (GI/L)
Interval -0.061 to -0.019
|
-0.023 Giga Units per Liter (GI/L)
Interval -0.044 to -0.001
|
SECONDARY outcome
Timeframe: 0-6 hours, post allergen challenge, 1 hour post treatment, Day 14Population: ITT Population
Number of peripheral blood eosinophils measured from blood draws
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo
|
FP 100 mcg BID
n=23 Participants
Fluticasone Propionate (FP) 100 mcg BID
|
SFC 50/100 mcg BID
n=20 Participants
Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID
|
|---|---|---|---|
|
Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14
|
-0.023 Giga Units per Liter (GI/L)
Interval -0.039 to -0.006
|
-0.022 Giga Units per Liter (GI/L)
Interval -0.038 to -0.007
|
-0.013 Giga Units per Liter (GI/L)
Interval -0.029 to -0.004
|
SECONDARY outcome
Timeframe: 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35Amount of serum interleukin (IL)-5 measured from blood draws
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0-6 hours post allergen challenge, 1 hour after dosing, Day 14Amount of serum IL-5 measured from blood draws
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
FP 100 mcg BID
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
SFC 50/100 BID
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=22 participants at risk
Placebo
|
FP 100 mcg BID
n=23 participants at risk
Fluticasone Propionate 100 mcg BID
|
SFC 50/100 BID
n=22 participants at risk
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
Other adverse events
| Measure |
Placebo
n=22 participants at risk
Placebo
|
FP 100 mcg BID
n=23 participants at risk
Fluticasone Propionate 100 mcg BID
|
SFC 50/100 BID
n=22 participants at risk
Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
31.8%
7/22
|
13.0%
3/23
|
9.1%
2/22
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
2/22
|
13.0%
3/23
|
9.1%
2/22
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolarngeal Pain
|
4.5%
1/22
|
8.7%
2/23
|
9.1%
2/22
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
4.5%
1/22
|
8.7%
2/23
|
0.00%
0/22
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
1/22
|
4.3%
1/23
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/22
|
4.3%
1/23
|
4.5%
1/22
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/22
|
4.3%
1/23
|
4.5%
1/22
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22
|
4.3%
1/23
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/22
|
4.3%
1/23
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
4.5%
1/22
|
0.00%
0/23
|
4.5%
1/22
|
|
Infections and infestations
Sinusitis
|
0.00%
0/22
|
4.3%
1/23
|
4.5%
1/22
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
|
Infections and infestations
Appendicitis
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
|
Infections and infestations
Candidiasis
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
|
General disorders
Chest discomfort
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
|
General disorders
Discomfort
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
|
Eye disorders
Eye pruritus
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
|
Nervous system disorders
Nerve compression
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal disorder
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
|
Immune system disorders
House dust allergy
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER