Trial Outcomes & Findings for Chronic Obstructive Pulmonary Disease (COPD) Post-hospitalization Study (NCT NCT01110200)
NCT ID: NCT01110200
Last Updated: 2017-11-08
Results Overview
A COPD exacerbation (EX) was defined as the worsening of \>=2 major symptoms (dyspnoea, sputum volume, sputum purulence \[containing/discharging pus\]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold \[nasal discharge and/or nasal conjestion\], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur \>21 days post-discharge/physician's office visit for a prior COPD EX.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
639 participants
Primary outcome timeframe
From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks
Results posted on
2017-11-08
Participant Flow
Participant milestones
| Measure |
FSC 250/50
Participants (par.) self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
SAL 50
Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
|---|---|---|
|
Overall Study
STARTED
|
314
|
325
|
|
Overall Study
COMPLETED
|
208
|
204
|
|
Overall Study
NOT COMPLETED
|
106
|
121
|
Reasons for withdrawal
| Measure |
FSC 250/50
Participants (par.) self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
SAL 50
Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
|---|---|---|
|
Overall Study
Adverse Event
|
28
|
28
|
|
Overall Study
Withdrawal by Subject
|
25
|
32
|
|
Overall Study
Lack of Efficacy
|
16
|
25
|
|
Overall Study
Protocol Violation
|
14
|
12
|
|
Overall Study
Physician Decision
|
13
|
17
|
|
Overall Study
Lost to Follow-up
|
10
|
7
|
Baseline Characteristics
Chronic Obstructive Pulmonary Disease (COPD) Post-hospitalization Study
Baseline characteristics by cohort
| Measure |
FSC 250/50
n=314 Participants
Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
SAL 50
n=325 Participants
Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
Total
n=639 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 Years
STANDARD_DEVIATION 9.15 • n=93 Participants
|
62.7 Years
STANDARD_DEVIATION 9.30 • n=4 Participants
|
62.9 Years
STANDARD_DEVIATION 9.22 • n=27 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=93 Participants
|
151 Participants
n=4 Participants
|
291 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
174 Participants
n=93 Participants
|
174 Participants
n=4 Participants
|
348 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage (AA/AH)
|
26 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese/South East and East Asian Heritage
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
284 Participants
n=93 Participants
|
300 Participants
n=4 Participants
|
584 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
AA/AH & American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native & White
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeksPopulation: Intent-to-Treat (ITT) Population: all participants randomized to study drug
A COPD exacerbation (EX) was defined as the worsening of \>=2 major symptoms (dyspnoea, sputum volume, sputum purulence \[containing/discharging pus\]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold \[nasal discharge and/or nasal conjestion\], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur \>21 days post-discharge/physician's office visit for a prior COPD EX.
Outcome measures
| Measure |
FSC 250/50
n=314 Participants
Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
SAL 50
n=325 Participants
Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
|---|---|---|
|
Number of Par. With Chronic Obstructive Pulmonary Disease (COPD) EXs Requiring Hospitalization That Occurred >21 Days Post-discharge/Physician's Office Visit for a COPD EX Requiring Treatment With Oral Corticosteroids (OCSs) or OCSs and Antibiotics (ABs)
|
43 participants
|
39 participants
|
PRIMARY outcome
Timeframe: From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeksPopulation: ITT Population
A COPD EX was defined as the worsening of \>=2 major symptoms (dyspnoea, sputum volume, sputum purulence \[containing/discharging pus\]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold \[nasal discharge and/or nasal conjestion\], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur more than 21 days post-discharge or physician's office visit for a prior COPD EX.
Outcome measures
| Measure |
FSC 250/50
n=314 Participants
Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
SAL 50
n=325 Participants
Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
|---|---|---|
|
Number of Participants With the Indicated Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs
0
|
271 participants
|
286 participants
|
|
Number of Participants With the Indicated Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs
1
|
36 participants
|
31 participants
|
|
Number of Participants With the Indicated Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs
2
|
7 participants
|
5 participants
|
|
Number of Participants With the Indicated Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs
3
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs
4
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeksPopulation: ITT Population. Only those participants with an EX requiring hospitalization were assessed.
A COPD EX was defined as the worsening of \>=2 major symptoms (dyspnoea, sputum volume, sputum purulence \[containing/discharging pus\]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold \[nasal discharge and/or nasal conjestion\], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur more than 21 days post-discharge or physician's office visit for a prior COPD EX.
Outcome measures
| Measure |
FSC 250/50
n=43 Participants
Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
SAL 50
n=39 Participants
Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
|---|---|---|
|
Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs
|
50 Exacerbations
|
51 Exacerbations
|
SECONDARY outcome
Timeframe: From Baseline up to Week 29, approximatelyPopulation: ITT Population
A COPD EX was defined as the worsening of \>=2 major symptoms (dyspnoea, sputum volume, sputum purulence \[containing/discharging pus\]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold \[nasal discharge and/or nasal conjestion\], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit).
Outcome measures
| Measure |
FSC 250/50
n=314 Participants
Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
SAL 50
n=325 Participants
Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
|---|---|---|
|
Number of Participants With an EX of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization
|
102 participants
|
115 participants
|
SECONDARY outcome
Timeframe: From Baseline up to Week 29, approximatelyPopulation: ITT Population. Only those participants with an EX were assessed for hospitalization, treatment with OCSs, and treatment with ABs.
A COPD EX was defined as the worsening of \>=2 major symptoms (dyspnoea, sputum volume, sputum purulence \[containing/discharging pus\]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold \[nasal discharge and/or nasal conjestion\], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit).
Outcome measures
| Measure |
FSC 250/50
n=314 Participants
Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
SAL 50
n=325 Participants
Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
|---|---|---|
|
Number of EXs of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization (Alone and in Combination)
Number of EXs, n=314,325
|
156 exacerbations
|
182 exacerbations
|
|
Number of EXs of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization (Alone and in Combination)
Number of EXs requiring hospitalization, n=156,182
|
50 exacerbations
|
51 exacerbations
|
|
Number of EXs of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization (Alone and in Combination)
Number of EXs treated with OCSs, n=156, 182
|
140 exacerbations
|
167 exacerbations
|
|
Number of EXs of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization (Alone and in Combination)
Number of EXs treated with ABs, n=156, 182
|
121 exacerbations
|
144 exacerbations
|
Adverse Events
FSC 250/50
Serious events: 75 serious events
Other events: 88 other events
Deaths: 0 deaths
SAL 50
Serious events: 82 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FSC 250/50
n=314 participants at risk
Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
SAL 50
n=325 participants at risk
Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
15.0%
47/314
|
15.7%
51/325
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.96%
3/314
|
1.5%
5/325
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
4/314
|
0.31%
1/325
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.32%
1/314
|
0.62%
2/325
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/314
|
0.31%
1/325
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/314
|
0.31%
1/325
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/314
|
0.31%
1/325
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/314
|
0.31%
1/325
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/314
|
0.31%
1/325
|
|
Infections and infestations
Pneumonia
|
2.2%
7/314
|
1.5%
5/325
|
|
Infections and infestations
Bronchitis
|
0.96%
3/314
|
0.92%
3/325
|
|
Infections and infestations
Cellulitis
|
0.64%
2/314
|
0.31%
1/325
|
|
Infections and infestations
Lobar pneumonia
|
0.64%
2/314
|
0.31%
1/325
|
|
Infections and infestations
Urinary tract infection
|
0.96%
3/314
|
0.00%
0/325
|
|
Infections and infestations
Sepsis
|
0.32%
1/314
|
0.31%
1/325
|
|
Infections and infestations
Cystitis
|
0.32%
1/314
|
0.00%
0/325
|
|
Infections and infestations
Encephalitis herpes
|
0.32%
1/314
|
0.00%
0/325
|
|
Infections and infestations
Escherichia sepsis
|
0.32%
1/314
|
0.00%
0/325
|
|
Infections and infestations
Infective exacerbation, chronic obstructive airways disease
|
0.00%
0/314
|
0.31%
1/325
|
|
Infections and infestations
Lymphangitis
|
0.32%
1/314
|
0.00%
0/325
|
|
Infections and infestations
Pneumonia streptococcal
|
0.32%
1/314
|
0.00%
0/325
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/314
|
0.31%
1/325
|
|
Infections and infestations
Sinusitis
|
0.32%
1/314
|
0.00%
0/325
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/314
|
0.31%
1/325
|
|
Infections and infestations
Urosepsis
|
0.32%
1/314
|
0.00%
0/325
|
|
Cardiac disorders
Angina pectoris
|
0.64%
2/314
|
0.31%
1/325
|
|
Cardiac disorders
Cardiac failure congestive
|
0.32%
1/314
|
0.62%
2/325
|
|
Cardiac disorders
Acute myocardial infarction
|
0.32%
1/314
|
0.31%
1/325
|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
1/314
|
0.31%
1/325
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/314
|
0.31%
1/325
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/314
|
0.31%
1/325
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/314
|
0.31%
1/325
|
|
Cardiac disorders
Coronary artery disease
|
0.32%
1/314
|
0.00%
0/325
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/314
|
0.31%
1/325
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/314
|
0.31%
1/325
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/314
|
0.31%
1/325
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/314
|
0.31%
1/325
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/314
|
0.31%
1/325
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/314
|
0.62%
2/325
|
|
Nervous system disorders
Carotid artery stenosis
|
0.32%
1/314
|
0.00%
0/325
|
|
Nervous system disorders
Convulsion
|
0.32%
1/314
|
0.00%
0/325
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/314
|
0.31%
1/325
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.32%
1/314
|
0.00%
0/325
|
|
Nervous system disorders
Ischaemic stroke
|
0.32%
1/314
|
0.00%
0/325
|
|
Nervous system disorders
Myoclonus
|
0.32%
1/314
|
0.00%
0/325
|
|
Nervous system disorders
Presyncope
|
0.32%
1/314
|
0.00%
0/325
|
|
Nervous system disorders
Syncope
|
0.00%
0/314
|
0.31%
1/325
|
|
Nervous system disorders
Tension headache
|
0.00%
0/314
|
0.31%
1/325
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/314
|
0.31%
1/325
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.32%
1/314
|
0.00%
0/325
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/314
|
0.31%
1/325
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/314
|
0.31%
1/325
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/314
|
0.31%
1/325
|
|
Gastrointestinal disorders
Melaena
|
0.32%
1/314
|
0.00%
0/325
|
|
Gastrointestinal disorders
Nausea
|
0.32%
1/314
|
0.00%
0/325
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.32%
1/314
|
0.00%
0/325
|
|
Gastrointestinal disorders
Vomiting
|
0.32%
1/314
|
0.00%
0/325
|
|
General disorders
Chest pain
|
0.32%
1/314
|
0.92%
3/325
|
|
General disorders
Non-cardiac chest pain
|
0.32%
1/314
|
0.00%
0/325
|
|
General disorders
Oedema peripheral
|
0.32%
1/314
|
0.00%
0/325
|
|
General disorders
Sudden death
|
0.32%
1/314
|
0.00%
0/325
|
|
Metabolism and nutrition disorders
Dehydration
|
0.64%
2/314
|
0.31%
1/325
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/314
|
0.31%
1/325
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/314
|
0.31%
1/325
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/314
|
0.31%
1/325
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.32%
1/314
|
0.00%
0/325
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.32%
1/314
|
0.00%
0/325
|
|
Vascular disorders
Hypotension
|
0.64%
2/314
|
0.31%
1/325
|
|
Vascular disorders
Arterial thrombosis limb
|
0.32%
1/314
|
0.00%
0/325
|
|
Vascular disorders
Hypertension
|
0.32%
1/314
|
0.00%
0/325
|
|
Vascular disorders
Labile hypertension
|
0.32%
1/314
|
0.00%
0/325
|
|
Vascular disorders
Orthostatic hypotension
|
0.32%
1/314
|
0.00%
0/325
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/314
|
0.31%
1/325
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.32%
1/314
|
0.00%
0/325
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.32%
1/314
|
0.00%
0/325
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.32%
1/314
|
0.00%
0/325
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.32%
1/314
|
0.00%
0/325
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.32%
1/314
|
0.00%
0/325
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
0.32%
1/314
|
0.00%
0/325
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/314
|
0.31%
1/325
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/314
|
0.31%
1/325
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal carcinoma metastatic
|
0.00%
0/314
|
0.31%
1/325
|
|
Renal and urinary disorders
Renal failure acute
|
0.64%
2/314
|
0.00%
0/325
|
|
Renal and urinary disorders
Calculus ureteric
|
0.32%
1/314
|
0.00%
0/325
|
|
Renal and urinary disorders
Renal failure
|
0.32%
1/314
|
0.00%
0/325
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/314
|
0.31%
1/325
|
|
Psychiatric disorders
Mental status changes
|
0.64%
2/314
|
0.00%
0/325
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/314
|
0.31%
1/325
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/314
|
0.31%
1/325
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/314
|
0.31%
1/325
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/314
|
0.31%
1/325
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.32%
1/314
|
0.00%
0/325
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/314
|
0.31%
1/325
|
|
Hepatobiliary disorders
Cholangitis
|
0.32%
1/314
|
0.00%
0/325
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.32%
1/314
|
0.00%
0/325
|
Other adverse events
| Measure |
FSC 250/50
n=314 participants at risk
Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
SAL 50
n=325 participants at risk
Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
15.0%
47/314
|
15.7%
51/325
|
|
Nervous system disorders
Headache
|
6.1%
19/314
|
5.8%
19/325
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
15/314
|
6.2%
20/325
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
10/314
|
4.0%
13/325
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
11/314
|
3.1%
10/325
|
|
General disorders
Oedema peripheral
|
1.9%
6/314
|
4.3%
14/325
|
|
Gastrointestinal disorders
Nausea
|
1.6%
5/314
|
4.0%
13/325
|
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