Trial Outcomes & Findings for Study Of Allergic Rhinitis In Patients Who Also Have Asthma (NCT NCT00296491)
NCT ID: NCT00296491
Last Updated: 2016-12-16
Results Overview
Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.
COMPLETED
PHASE4
725 participants
Baseline to Endpoint (weeks 3-4)
2016-12-16
Participant Flow
Participant milestones
| Measure |
Flut Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)
Flut Prop = Fluticasone Propionate.
|
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)
|
Fluticasone Propionate/Salmeterol (FSC)
|
Montelukast (MON)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
182
|
182
|
180
|
181
|
|
Overall Study
COMPLETED
|
140
|
129
|
137
|
138
|
|
Overall Study
NOT COMPLETED
|
42
|
53
|
43
|
43
|
Reasons for withdrawal
| Measure |
Flut Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)
Flut Prop = Fluticasone Propionate.
|
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)
|
Fluticasone Propionate/Salmeterol (FSC)
|
Montelukast (MON)
|
|---|---|---|---|---|
|
Overall Study
Low Pollen Counts
|
18
|
26
|
25
|
16
|
|
Overall Study
Protocol Violation
|
4
|
6
|
2
|
3
|
|
Overall Study
Adverse Event
|
1
|
3
|
1
|
4
|
|
Overall Study
Withdrawn due to Asthma
|
0
|
0
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
3
|
2
|
|
Overall Study
Non-Compliance
|
12
|
13
|
10
|
14
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
0
|
Baseline Characteristics
Study Of Allergic Rhinitis In Patients Who Also Have Asthma
Baseline characteristics by cohort
| Measure |
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)
n=182 Participants
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) = FSC twice a day (BID), plus vehicle placebo nasal spray once a day (QD), plus MON once a day (QD)
|
Fluticasone Propionate/Salmeterol (FSC)
n=180 Participants
Fluticasone Propionate/Salmeterol (FSC) = FSC BID, plus vehicle placebo nasal spray once a day (QD), plus placebo capsule once a day (QD).
|
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)
n=182 Participants
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) = FSC twice a day (BID), plus FPANS (once a day) QD, plus placebo capsule once a day (QD).
|
Montelukast (MON)
n=181 Participants
Montelukast (MON) = Placebo DISKUS BID, plus vehicle placebo nasal spray once a day (QD), plus MON (once a day) QD.
|
Total
n=725 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.0 years
STANDARD_DEVIATION 13.54 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 14.64 • n=7 Participants
|
34.9 years
STANDARD_DEVIATION 12.62 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 12.47 • n=4 Participants
|
34.2 years
STANDARD_DEVIATION 13.34 • n=21 Participants
|
|
Gender
Female
|
115 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
449 Participants
n=21 Participants
|
|
Gender
Male
|
67 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
276 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
138 participants
n=5 Participants
|
138 participants
n=7 Participants
|
143 participants
n=5 Participants
|
145 participants
n=4 Participants
|
564 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
34 participants
n=5 Participants
|
35 participants
n=7 Participants
|
31 participants
n=5 Participants
|
30 participants
n=4 Participants
|
130 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Endpoint (weeks 3-4)Population: The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment.
Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.
Outcome measures
| Measure |
Fluticasone Prop/Salmeterol (FSC)
n=179 Participants
|
Montelukast (MON)
n=181 Participants
|
|---|---|---|
|
Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population
|
26.4 L/min
Standard Error 4.10
|
3.6 L/min
Standard Error 3.28
|
PRIMARY outcome
Timeframe: Baseline to Endpoint (weeks 3-4)Population: The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol.
Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.
Outcome measures
| Measure |
Fluticasone Prop/Salmeterol (FSC)
n=83 Participants
|
Montelukast (MON)
n=88 Participants
|
|---|---|---|
|
Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population
|
30.9 L/min
Standard Error 4.92
|
35.2 L/min
Standard Error 6.41
|
SECONDARY outcome
Timeframe: Baseline to 1-2 WeeksPopulation: The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC+FPANS and FSC+MON in the context of rhinitis measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.
The sum of scores of each of the four daytime symptoms (nasal congestion, itching, rhinorrhea, and sneezing). Scale: 0=none (no sign/symptom evident)1=mild (sign/symptom clearly present; easily tolerated)2=moderate (definite awareness of sign/symptom that is bothersome but tolerable)3=severe (sign/symptom is hard to tolerate)
Outcome measures
| Measure |
Fluticasone Prop/Salmeterol (FSC)
n=181 Participants
|
Montelukast (MON)
n=181 Participants
|
|---|---|---|
|
Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS).
|
-2.3 Points on a Scale
Standard Error 0.16
|
-3.0 Points on a Scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline To 1-2 WeeksPopulation: The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC+FPANS and FSC+MON in the context of rhinitis measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.
The scores of 3 nighttime symptoms (nasal congestion upon awakening, difficulty going to sleep due to nasal symptoms, nighttime awakenings due to nasal symptoms). Scale: 0=not noticeable, 1=noticeable but not bothersome, 2=noticeable and bothersome some of the time, 3=bothersome most of the time and/or very bothersome some of the time.
Outcome measures
| Measure |
Fluticasone Prop/Salmeterol (FSC)
n=181 Participants
|
Montelukast (MON)
n=181 Participants
|
|---|---|---|
|
Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS)
|
-2.0 Points on a Scale
Standard Error 0.13
|
1.7 Points on a Scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline to Endpoint (weeks 3-4)Population: The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.
Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.
Outcome measures
| Measure |
Fluticasone Prop/Salmeterol (FSC)
n=178 Participants
|
Montelukast (MON)
n=180 Participants
|
|---|---|---|
|
Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population
|
0.15 L/sec
Standard Error 0.02
|
0.04 L/sec
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline to Endpoint (weeks 3-4)Population: The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.
Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.
Outcome measures
| Measure |
Fluticasone Prop/Salmeterol (FSC)
n=83 Participants
|
Montelukast (MON)
n=88 Participants
|
|---|---|---|
|
Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population
|
0.27 L/sec
Standard Error 0.04
|
0.13 L/sec
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline to Endpoint (weeks 3-4)Population: The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.
Endpoint was defined as the average of the data reported from the last week of treatment.Asthma symptom scores and the subject-rated overall satisfaction with treatment, related to the percentage of asthma symptom-free days. Same scale used as in outcome 8.
Outcome measures
| Measure |
Fluticasone Prop/Salmeterol (FSC)
n=179 Participants
|
Montelukast (MON)
n=181 Participants
|
|---|---|---|
|
Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population
|
34.8 Percentage of asthma symptom-free days
Standard Error 2.94
|
26.1 Percentage of asthma symptom-free days
Standard Error 2.83
|
SECONDARY outcome
Timeframe: Baseline to Endpoint (weeks 3-4)Population: The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.
Asthma symptom score:0=no symptoms,1=symptoms 1 short period,2=symptoms 2 or more short periods,3=symptoms most of day not affect activities,4=symptoms most of day did affect activities,5=symptoms severe.Overall satisfaction score:0=very dissatisfied,1=dissatisfied,2=slightly dissatisfied,3=neutral,4=slightly satisfied,5=satisfied 6=very satisfied
Outcome measures
| Measure |
Fluticasone Prop/Salmeterol (FSC)
n=83 Participants
|
Montelukast (MON)
n=88 Participants
|
|---|---|---|
|
Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population
|
34.8 Percentage of asthma symptom-free days
Standard Error 4.32
|
37.1 Percentage of asthma symptom-free days
Standard Error 4.23
|
SECONDARY outcome
Timeframe: Baseline to Endpoint (weeks 3-4)Population: The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.
Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).
Outcome measures
| Measure |
Fluticasone Prop/Salmeterol (FSC)
n=179 Participants
|
Montelukast (MON)
n=181 Participants
|
|---|---|---|
|
Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population
|
37.5 Percentage of rescue-free days
Standard Error 2.84
|
26.7 Percentage of rescue-free days
Standard Error 2.92
|
SECONDARY outcome
Timeframe: Baseline to Endpoint (weeks 3-4)Population: The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.
Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).
Outcome measures
| Measure |
Fluticasone Prop/Salmeterol (FSC)
n=83 Participants
|
Montelukast (MON)
n=88 Participants
|
|---|---|---|
|
Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population
|
41.2 Percentage of rescue-free days
Standard Error 3.97
|
42.9 Percentage of rescue-free days
Standard Error 4.20
|
Adverse Events
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)
Fluticasone Propionate/Salmeterol (FSC)
Montelukast (MON)
Serious adverse events
| Measure |
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)
n=182 participants at risk
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) = FSC twice a day (BID), plus FPANS (once a day) QD, plus placebo capsule once a day (QD).
|
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)
n=182 participants at risk
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) = FSC twice a day (BID), plus vehicle placebo nasal spray once a day (QD), plus MON once a day (QD)
|
Fluticasone Propionate/Salmeterol (FSC)
n=180 participants at risk
Fluticasone Propionate/Salmeterol (FSC) = FSC BID, plus vehicle placebo nasal spray once a day (QD), plus placebo capsule once a day (QD).
|
Montelukast (MON)
n=181 participants at risk
Montelukast (MON) = Placebo DISKUS BID, plus vehicle placebo nasal spray once a day (QD), plus MON (once a day) QD.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.00%
0/181
|
|
Infections and infestations
Appendicitis
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
Other adverse events
| Measure |
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)
n=182 participants at risk
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) = FSC twice a day (BID), plus FPANS (once a day) QD, plus placebo capsule once a day (QD).
|
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)
n=182 participants at risk
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) = FSC twice a day (BID), plus vehicle placebo nasal spray once a day (QD), plus MON once a day (QD)
|
Fluticasone Propionate/Salmeterol (FSC)
n=180 participants at risk
Fluticasone Propionate/Salmeterol (FSC) = FSC BID, plus vehicle placebo nasal spray once a day (QD), plus placebo capsule once a day (QD).
|
Montelukast (MON)
n=181 participants at risk
Montelukast (MON) = Placebo DISKUS BID, plus vehicle placebo nasal spray once a day (QD), plus MON (once a day) QD.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.55%
1/182
|
0.55%
1/182
|
1.7%
3/180
|
2.2%
4/181
|
|
Infections and infestations
Nasopharyngitis
|
0.55%
1/182
|
1.6%
3/182
|
2.2%
4/180
|
0.00%
0/181
|
|
Infections and infestations
Sinusitis
|
1.6%
3/182
|
0.00%
0/182
|
2.2%
4/180
|
0.55%
1/181
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/182
|
0.55%
1/182
|
0.56%
1/180
|
0.55%
1/181
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/182
|
0.55%
1/182
|
1.1%
2/180
|
0.00%
0/181
|
|
Infections and infestations
Gastroenteritis
|
1.1%
2/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Infections and infestations
Influenza
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/182
|
1.1%
2/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
Appendicitis
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
Bronchitis
|
0.55%
1/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
Cystitis
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.00%
0/181
|
|
Infections and infestations
Eye infection
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
Laryngitis
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Infections and infestations
Oral herpes
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.00%
0/181
|
|
Infections and infestations
Otitis media
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Infections and infestations
Viral infection
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.00%
0/181
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Nervous system disorders
Headache
|
3.8%
7/182
|
3.8%
7/182
|
4.4%
8/180
|
4.4%
8/181
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/182
|
1.1%
2/182
|
1.7%
3/180
|
0.55%
1/181
|
|
Nervous system disorders
Migraine
|
0.55%
1/182
|
0.55%
1/182
|
0.56%
1/180
|
0.00%
0/181
|
|
Nervous system disorders
Dizziness
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Nervous system disorders
Tremor
|
0.55%
1/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
2/182
|
0.55%
1/182
|
1.7%
3/180
|
0.55%
1/181
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.55%
1/182
|
1.1%
2/182
|
0.56%
1/180
|
0.55%
1/181
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.55%
1/182
|
0.55%
1/182
|
0.56%
1/180
|
0.55%
1/181
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.55%
1/181
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/182
|
0.55%
1/182
|
0.56%
1/180
|
0.00%
0/181
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.1%
2/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.55%
1/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.55%
1/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.55%
1/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/182
|
0.55%
1/182
|
2.2%
4/180
|
1.7%
3/181
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.55%
1/182
|
0.55%
1/182
|
1.1%
2/180
|
2.2%
4/181
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.55%
1/182
|
0.00%
0/182
|
0.56%
1/180
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.55%
1/181
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/182
|
0.55%
1/182
|
0.56%
1/180
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.55%
1/181
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis perennial
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.00%
0/181
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
2/182
|
0.00%
0/182
|
0.00%
0/180
|
1.7%
3/181
|
|
Gastrointestinal disorders
Nausea
|
1.1%
2/182
|
0.55%
1/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
1.1%
2/181
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
1.7%
3/181
|
|
Gastrointestinal disorders
Food poisoning
|
0.55%
1/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.55%
1/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.55%
1/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.55%
1/181
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.55%
1/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.55%
1/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/182
|
0.55%
1/182
|
0.56%
1/180
|
1.7%
3/181
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.00%
0/181
|
|
General disorders
Pyrexia
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
1.1%
2/181
|
|
General disorders
Chest pain
|
0.00%
0/182
|
0.55%
1/182
|
0.56%
1/180
|
0.00%
0/181
|
|
General disorders
Injection site pain
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.00%
0/181
|
|
General disorders
Oedema peripheral
|
0.55%
1/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.55%
1/181
|
|
Eye disorders
Eye pruritis
|
1.1%
2/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Eye disorders
Dry eye
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Eye disorders
Eye swelling
|
0.55%
1/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.55%
1/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.00%
0/181
|
|
Immune system disorders
Food allergy
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Immune system disorders
Hypersensitivity
|
0.55%
1/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Psychiatric disorders
Anorgasmia
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/182
|
0.00%
0/182
|
0.56%
1/180
|
0.00%
0/181
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/182
|
0.00%
0/182
|
0.00%
0/180
|
0.55%
1/181
|
|
Investigations
Weight increased
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Surgical and medical procedures
Shoulder operation
|
0.55%
1/182
|
0.00%
0/182
|
0.00%
0/180
|
0.00%
0/181
|
|
Vascular disorders
Haematoma
|
0.00%
0/182
|
0.55%
1/182
|
0.00%
0/180
|
0.00%
0/181
|
Additional Information
GSK Response Center
GlaxoSmithKline
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 centres of a multi-centre 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