Influence Of Salmeterol Xinafoate/Fluticasone Propionate... | NCT00527826

NCT00527826

Status Module

Description Module

Label	Type	Description	Intervention Names
arm 1	Active Comparator		Drug: Salmeterol / Fluticasone (50/500 µg) BID fixed combination
arm 2	Active Comparator		Drug: Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers

Name	Type	Description	Arm Group Labels	Other Names
Salmeterol / Fluticasone (50/500 µg) BID fixed combination	Drug	comparator	arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Number of Exacerbations Per Year: Negative Binomial Model	During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.	Baseline through Week 52
Mean Number of Exacerbations Per Year: Poisson Model	During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.	Baseline through Week 52

Secondary Outcomes

Measure	Description	Time Frame
Compliance and Adherence to Study Medication	Compliance is calculated as the ratio (in percent) between the number of actual doses taken during the total treatment period divided by the number of doses that should have been taken during the total treatment period.	Baseline through Week 52
Mean Number of COPD-related Visits at/by Physician

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Subject must have a diagnosis of COPD based on the American Thoracic Society (ATS)/ European Respiratory Society (ERS) criteria.
Male or female subjects, aged >=40 years. Females must be of Non Child Bearing Potential. The definition of Non Child Bearing Potential is as following: Females, regardless of their age, with functioning ovaries and who have a current documented tubal ligation or hysterectomy, or females who are post-menopausal.
Have diagnosed COPD stage III or IV according to GOLD criteria: a baseline post-bronchodilator Forced Expiratory Volume, measured at 1 second (FEV1) <50% of predicted normal and a baseline post- bronchodilator FEV1/Inspiratory Vital Capacity (IVC) ratio <70%.
Have experienced at least 2 moderate or severe COPD exacerbations leading to medical consultation (requiring oral corticosteroids or increasing dosage of oral corticosteroids and/or antibiotics or hospitalization) within the 12 months preceding Visit 1.
Have stable COPD medication within 4 weeks prior to Visit 1 (no new medication added and no dosage changes in medication).
Current or ex-smokers with a smoking history of at least 10 pack years (number of pack years = [number of cigarettes per day / 20] x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
Are currently managed at home (outpatients), are ambulatory and able to travel to the clinic. Subjects can be treated with all relevant COPD medication. This includes vaccines, inhaled short-acting beta-2-agonists as needed, short-acting or long-acting anticholinergics (tiotropium), systemic beta-2-agonists, theophylline, mucolytics, antioxidants, beta-1-agonists (for cardiovascular indication), non-invasive ventilation, long term oxygen therapy and can have Cor Pulmonale.
A signed and dated written informed consent is obtained prior to participation.
Able to comply with the requirements of the protocol and be available for study visits over 52 weeks.

Exclusion criteria:

Known other respiratory disorders or signs for other respiratory disorders (e.g. asthma, lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis, bronchoectasis).
Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and systemic lupus erythematosus).
Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ)
Having undergone lung surgery (e.g. lung resection including lung volume reduction surgery, lung transplant) or subjects scheduled for surgery.
Concurrent medication from Visit 1 and for the duration of the study with any of the prohibited medications: monoamine oxidase inhibitors and tricyclic antidepressants, and ritonavir (a highly potent cytochrome P450 3A4 inhibitor).
Subjects receiving chronic or prophylactic antibiotic therapy.
Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety.
Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
History of depression.
History or presence of clinically significant drug sensitivity or clinically significant allergic reaction to corticosteroids or salmeterol.
Moderate or severe COPD exacerbation (requiring corticosteroids or increased dosage of corticosteroids and/or antibiotics or hospitalization) within the 4 weeks prior to Visit 1
Lower respiratory tract infection within the 4 weeks prior to Visit 1 .
Pregnant or lactating female and female of childbearing potential.
Subject is a participating investigator, sub-investigator, study coordinator, or other employee of a participating investigator, or is an immediate family member of the before mentioned. Subject is an employee of GlaxoSmithKline (GSK).
Subject participated in an investigational drug study within 30 days prior to Visit 1

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Bruchsal	Baden-Wurttemberg	76646	Germany
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
23337300	Derived	Hagedorn C, Kassner F, Banik N, Ntampakas P, Fielder K. Influence of salmeterol/fluticasone via single versus separate inhalers on exacerbations in severe/very severe COPD. Respir Med. 2013 Apr;107(4):542-9. doi: 10.1016/j.rmed.2012.12.020. Epub 2013 Jan 20.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
FG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Age at study start (years). The Intent-to-Treat (ITT) Population (all participants receiving at least one dose of study medication and suffering from COPD) was used for all baseline characteristics.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00065.6± 8.3 BG00164.2± 8.9 BG00264.9± 8.6

Sex: Female, Male

The ITT Population was used.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00033 BG00129 BG002

Severity of Chronic Obstructive Lung Disease (COPD)

Severe COPD (stage III) is defined by the global initiative for chronic obstructive lung disease (GOLD) as baseline forced expiratory volume in one second (FEV1) >30% and <50% predicted and FEV1/inspiratory vital capacity (IVC) ratio <70%. Very severe COPD (stage IV) is defined as baseline FEV1 <30% predicted and FEV1/IVC <70%. ITT Population.

Number

participants

Title

Denominators

Categories

Severe COPD

Title	Measurements
	BG00077 BG001

Smoking History

The number of smokers/ex-smokers participating in the study was recorded. The ITT Population was used.

Number

participants

Title

Denominators

Categories

Ex-smoker

Title	Measurements
	BG00074 BG00178 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Number of Exacerbations Per Year: Negative Binomial Model

During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.

Intent-to-Treat (ITT) Population: all participants receiving at least one dose of study medication and suffering from COPD

Posted

Least Squares Mean

Standard Error

Number of exacerbations per year

Baseline through Week 52

ID	Title	Description
OG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
OG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)

Units	Counts
Participants	OG000107 OG001105

Title

Denominators

Categories

Title	Measurements
	OG0000.864± 0.134 OG0010.862± 0.138

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Negative binomial model	Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.	0.73							95						Yes	Non-Inferiority or Equivalence	Negative binomial model for the rate of exacerbations (per year) using the treatment duration as offset term and treatment, COPD severity (stratum) and interaction as fixed factors. This model took further into account a strata imbalance of 73% COPD III vs. 27% COPD IV according to the observed rates (SAS code: proc GENMOD).

Secondary

Compliance and Adherence to Study Medication

Compliance is calculated as the ratio (in percent) between the number of actual doses taken during the total treatment period divided by the number of doses that should have been taken during the total treatment period.

ITT Population

Posted

Mean

Standard Deviation

percentage of doses

Baseline through Week 52

ID	Title	Description
OG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
OG001	Sal 50 µg	Salmeterol xinafoate (Sal) 50 µg BID (morning and evening) from a separate inhaler (SEVERENT Diskus)
OG002	FP 500 µg	Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)

Units	Counts

Primary

Mean Number of Exacerbations Per Year: Poisson Model

ITT Population

Posted

Least Squares Mean

Standard Error

Number of exacerbations per year

Baseline through Week 52

ID	Title	Description
OG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
OG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)

Secondary

Mean Number of COPD-related Visits at/by Physician

The total number of COPD-related visits, i.e., from baseline through week 52, the number of visits at physician's office, the number of home visits made by physician, the number of visits at an emergency outpatient clinic, as well as the number of home visits by an emergency physician were summed up.

ITT Population with non-missing data (due to early withdrawal some data for this outcome measure are missing)

Posted

Mean

Standard Deviation

number of visits

Baseline through Week 52

ID	Title	Description
OG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
OG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
OG002	Total	Total number of participants randomized to the SFC and Sal/FP groups

Secondary

Number of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)

The number participants with the indicated number of days at the ICU was recorded.

ITT Population of participants who were admitted to the ICU

Posted

Number

participants

Baseline through Week 52

ID	Title	Description
OG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
OG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
OG002	Total	Total number of participants randomized to the SFC and Sal/FP groups

Units	Counts
Participants

Secondary

Number of Participants With the Indicated Number of Hospital Stays

The number of participants with the indicated number of hospitalizations was recorded.

ITT Population

Posted

Number

participants

Baseline through Week 52

ID	Title	Description
OG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
OG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
OG002	Total	Total number of participants randomized to the SFC and Sal/FP groups

Units	Counts
Participants

Secondary

Mean Number of Days Rescue Medication Was Used

Participants were asked for the number of days they used rescue medication within the 7 days before Week 8 and Week 52.

ITT Population with non-missing data (due to early withdrawal, some data for this outcome measure are missing).

Posted

Mean

Standard Deviation

number of days

The 7 days before baseline (=Visit 2 [Week 8]) and the last 7 days of study (=Visit 6 [Week 52])

ID	Title	Description
OG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
OG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
OG002	Total	Total number of participants randomized to the SFC and Sal/FP groups

Secondary

Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52

Change from baseline was calculated as the FEV1 percent predicted value at Week 52 minus the percent predicted value at baseline. The post-bronchodilator lung function test was performed to measure FEV1 30 minutes after inhaling salbutamol. The most reliable result of three different consecutive measurements was documented.

ITT Population

Posted

Mean

Standard Deviation

percent of predicted value

Baseline and Week 52

ID	Title	Description
OG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
OG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
OG002	Total	Total number of participants randomized to the SFC and Sal/FP groups

Secondary

Mean Change From Baseline in Inspiratory Vital Capacity (IVC) at Week 52

Change from baseline was measured as the IVC value at Week 52 minus the value at baseline. The post-bronchodilator lung function test was performed to measure IVC 30 minutes after inhaling salbutamol. The most reliable result of three different, consecutive measurements was documented.

ITT Population

Posted

Mean

Standard Deviation

liters

Baseline and Week 52

ID	Title	Description
OG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
OG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
OG002	Total	Total number of participants randomized to the SFC and Sal/FP groups

Secondary

Mean Change From Baseline in the Tiffeaneau Index at Week 52

The Tiffeneau index is defined as the FEV1 divided by the IVC (i.e., forced expiratory volume in one second relative to the inspiratory capacity) in percent. Change from baseline is calculated as the FEV1/IVC value at Week 52 minus the value at baseline.

ITT Population

Posted

Mean

Standard Deviation

percent of IVC

Baseline and Week 52

ID	Title	Description
OG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
OG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
OG002	Total	Total number of participants randomized to the SFC and Sal/FP groups

Secondary

Mean Change From Baseline in the Symptom Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52

Change from baseline is calculated as the symptom score at Week 52 minus the symptom score at baseline. The SGRQ (a self-administered questionnaire) subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life (summed weights of 8 questions). A score of 0 indicates the best possible status.

ITT Population

Posted

Mean

Standard Deviation

percent

Baseline and Week 52

ID	Title	Description
OG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
OG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
OG002	Total	Total number of participants randomized to the SFC and Sal/FP groups

Secondary

Mean Change From Baseline in the Activity Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52

Change from baseline is calculated as the activity score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale activity score ranges from 0 to 100% and is concerned with activities that cause or are limited by breathlessness (summed weights of 2 questions). A score of 0 indicates the best possible status.

ITT Population

Posted

Mean

Standard Deviation

percent

Baseline and Week 52

ID	Title	Description
OG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
OG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
OG002	Total	Total number of participants randomized to the SFC and Sal/FP groups

Secondary

Mean Change From Baseline in the Impact Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52

Change from baseline was calculated as the impact score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale impact score ranges from 0 to 100% and is concerned with social functioning and psychological disturbances (summed weights of 5 questions). A score of 0 indicates the best possible status.

ITT Population

Posted

Mean

Standard Deviation

percent

Baseline and Week 52

ID	Title	Description
OG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
OG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
OG002	Total	Total number of participants randomized to the SFC and Sal/FP groups

Secondary

Mean Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52

Change from baseline was calculated as the total score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) total score ranges from 0 to 100% and summarizes the impact of COPD on overall health status (summed weights of 15 questions). A total score of 0 indicates the best possible status.

ITT Population

Posted

Mean

Standard Deviation

percent

Baseline and Week 52

ID	Title	Description
OG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
OG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
OG002	Total	Total number of participants randomized to the SFC and Sal/FP groups

Secondary

Mean Total Costs (Related to COPD) Per Participant

Total costs include costs for hospitalization, medication, and visits to/by physician. Medications that were used "as required" were assumed to be used every second day.

ITT Population

Posted

Mean

Standard Deviation

Euros per participant

Baseline through Week 52

ID	Title	Description
OG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
OG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
OG002	Total	Total number of participants randomized to the SFC and Sal/FP groups

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected108 at risk EG0011 affected105 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected108 at risk EG0011 affected105 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0011 affected105 at risk
Cyanosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected108 at risk EG0011 affected105 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Duodenal stenosis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Duodenitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected108 at risk EG0011 affected105 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected108 at risk EG0011 affected105 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected108 at risk EG0011 affected105 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected108 at risk EG0011 affected105 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected108 at risk EG0011 affected105 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected108 at risk EG0014 affected105 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0011 affected105 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected108 at risk EG0011 affected105 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected108 at risk EG0011 affected105 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected108 at risk EG0011 affected105 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00012 affected108 at risk EG0017 affected105 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected108 at risk EG0011 affected105 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected108 at risk EG0011 affected105 at risk
Cardioplegia	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 affected108 at risk EG0011 affected105 at risk
Arterial occlusive disease	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected108 at risk EG0010 affected105 at risk

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D010349	Patient Compliance

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

ID	Term
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D010627	Phenethylamines
D005021	Ethylamines
D000730	Androstadienes
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
BG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg	Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)			23	108	45	108
EG001	Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg	Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)			16	105	48	105