Dose Finding Study on BI54903 (Inhaled Corticosteroid) Ad... | NCT01397162

ID	Type	Description	Link
2010-023167-17	EudraCT Number	EudraCT

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BI 54903 - low dose	Experimental	BI 54903 low dose 2 puffs twice daily (b.i.d.) via Respimat inhaler plus hydrofluoralkane (HFA) metered dose inhaler (MDI) matching placebo 2 puffs b.i.d.	Drug: BI 54903
BI 54903 - medium dose	Experimental	BI 54903 medium dose 2 puffs b.i.d. via Respimat inhaler plus HFA MDI matching placebo 2 puffs b.i.d.	Drug: BI 54903
BI 54903 - high dose	Experimental	BI 54903 high dose 2 puffs b.i.d. via Respimat inhaler plus HFA MDI matching placebo 2 puffs b.i.d.	Drug: BI 54903
Fluticasone propionate	Active Comparator	Fluticasone propionate 2 puffs twice b.i.d via HFA MDI plus placebo BI 54903 via Respimat inhaler 2 puffs b.i.d.	Drug: Fluticasone propionate
Placebo	Placebo Comparator	Placebo Respimat inhaler 2 puffs b.i.d. and placebo HFA MDI, 2 puffs b.i.d.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Fluticasone propionate	Drug	Fluticasone propionate	Fluticasone propionate

Measure	Description	Time Frame
Mean Change From the Randomisation Baseline to the End of the 8-week Treatment Period in Trough (Morning Pre-dose and Pre-rescue Bronchodilator ) Forced Expiratory Volume in One Second (FEV1)	Mean change from the randomisation baseline to the end of the 8-week treatment period in trough (morning pre-dose and pre-rescue bronchodilator ) forced expiratory volume in one second (FEV1).	At baseline and week 8.

Measure	Description	Time Frame
Mean Changes From Randomisation Baseline in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in One Second (FEV1) After 2 and 4-week Treatment Periods	Mean changes from randomisation baseline in trough (pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1) after 2 and 4-week treatment periods.	At baseline and at week 2 and 4.

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Male and female patients aged at least 12 to 65 years
All patients must have a history of asthma diagnosed by a physician for at least three months at the time of enrolment into the trial according to the 2009 Global Initiative for Asthma (GINA) Guidelines. The initial diagnosis of asthma must have been made before the age of 40 years 4 All patients must be on a maintenance treatment with either low-dose inhaled corticosteroid (ICS) plus long-acting-beta -agonist (LABA) or medium-dose ICS without LABA, stable for at least six weeks prior to Visit 1

5 All patients must have a pre-bronchodilator FEV1 of not less than 60 to 90% of predicted normal and an asthma control questionnaire (ACQ-6) mean score of less than 1.5 at the pre-screening Visit 1 6 All patients must have an improvement in forced expiratory volume in one second (FEV1) not less than 12 % above baseline and an absolute change of at least 200 mL within 15-30 min after administration of 400 mcg salbutamol/albuterol hydrofluoroalkane metered dose inhaler (HFA MDI) 7 Patients must be never-smokers or ex-smokers with a smoking history of less than 10 pack-years and smoking cessation at least one year prior to screening 9 Patients must be able to use Respimat® inhaler and metered dose inhaler (MDI) correctly 10 Patients must be able to perform all trial-related procedures including technically acceptable pulmonary function tests and electronic peak expiratory flow (PEF) measurements, and must be able to maintain records during the study period as required in the protocol

Exclusion criteria:

Patients with significant pulmonary disease other than asthma or other significant medical conditions (as determined by medical history, examination and clinical investigations at screening)
Patients with a clinically relevant, abnormal screening haematology and/or blood chemistry finding
Patients with a history of upper or lower respiratory tract infection (URTI/LRTI) in the past four weeks prior to the pre-screening Visit 1, and during pre-screening and run-in periods
Patients with any exacerbation of their underlying asthma during the eight weeks prior to the pre-screening Visit 1
Patients with active allergic rhinitis requiring treatment with systemic corticosteroids
Any of the following criteria are met during the pre-screening / run-in period (Visits 1 - 6):in clinic pre-bronchodilator forced expiratory volume in one second (FEV1 %) predicted less than 40%; more than 12 puffs rescue salbutamol/albuterol HFA MDI per day for > 2 consecutive days;exacerbation of asthma
Patients with a history of pneumonectomy or who are planning to undergo thoracotomy for any reason
Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to the first screening visit 1
Patients with two or more hospitalizations for asthma within the previous 12 months
Patients with a recent history of myocardial infarction during the last twelve months or known coronary heart disease that requires treatment
Patients with a history of hospitalisation due to heart failure in the past twelve months
Patients with myocarditis or any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year
Patients with significant alcohol or drug abuse in the opinion of the investigator within the past two years
Patients with rheumatoid arthritis or other systemic diseases that require immune system modulating treatment
Patients suffering from narrow angle glaucoma with a history of glaucoma, increased intraocular pressure, and/or cataracts
Pregnant or nursing women
Women of childbearing potential not using a highly effective method of birth control
Patients who have been treated with anti-Immunoglobin-E-antibodies (e.g. omalizumab, Xolair®) or other immune system modulating antibodies such as tumor necrosis factor-alpha blockers within six months prior to Visit 1
Patients who have been treated with the following drugs during the past four weeks prior to Visit 1 or are foreseen to need this during the study:Non-selective beta-blockers (topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed; Oral or other systemic corticosteroids; Oral beta-agonists; Changes in allergen desensitisation therapy in last 6 months; Immune system modulating agents such as methotrexate or cyclosporine; Inhibitors of cytochrome P450 3A4 such as antifungals (e.g. ketoconazole, itraconazole), antibiotics (e.g. erythromycin) or antiretroviral drugs; Patients who have been treated with leukotriene modifiers, chromones or theophylline within two weeks prior to Visit 1; Patients who have been treated with tiotropium within 3 weeks prior to Visit 1

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1248.5.01047 Boehringer Ingelheim Investigational Site		Fountain Valley	California		United States

Label	URL
Related Info	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo HFA MDI	Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
FG001	BI 54903 22.7µg Bid	2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo HFA MDI	Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
BG001	BI 54903 22.7µg Bid	2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
BG002	BI 54903 45.5µg Bid	2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) b.i.d.) for a treatment period of 8 weeks.
BG003	BI 54903 90.9µg Bid	2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
BG004	Fluticasone Propionate 88µg Bid	2 puffs of 44 µg (total 88 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.
BG005	Total	Total of all reporting groups

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 Change From the Randomisation Baseline to the End of the 8-week Treatment Period in Trough (Morning Pre-dose and Pre-rescue Bronchodilator ) Forced Expiratory Volume in One Second (FEV1)

Mean change from the randomisation baseline to the end of the 8-week treatment period in trough (morning pre-dose and pre-rescue bronchodilator ) forced expiratory volume in one second (FEV1).

Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.

Posted

At baseline and week 8.

ID	Title	Description
OG000	Placebo HFA MDI	Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
OG001	BI 54903 22.7µg Bid	2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
OG002	BI 54903 45.5µg Bid	2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) b.i.d.) for a treatment period of 8 weeks.
OG003	BI 54903 90.9µg Bid	2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
OG004	Fluticasone Propionate 88µg Bid	2 puffs of 44 µg (total 88 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Mean Changes From Randomisation Baseline in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in One Second (FEV1) After 2 and 4-week Treatment Periods

Mean changes from randomisation baseline in trough (pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1) after 2 and 4-week treatment periods.

Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.

Posted

At baseline and at week 2 and 4.

ID	Title	Description
OG000	Placebo HFA MDI	Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
OG001	BI 54903 22.7µg Bid	2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
OG002	BI 54903 45.5µg Bid	2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) b.i.d.) for a treatment period of 8 weeks.

Secondary

Mean Changes From Randomisation Baseline in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Vital Capacity (FVC) After 2, 4 and 8-week Treatment Periods

Mean changes from randomisation baseline in trough (pre-dose and pre-rescue bronchodilator) forced vital capacity (FVC) after 2, 4 and 8-week treatment periods.

Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.

Posted

At baseline and week 2, 4, 8.

ID	Title	Description
OG000	Placebo HFA MDI	Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
OG001	BI 54903 22.7µg Bid	2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
OG002	BI 54903 45.5µg Bid	2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) b.i.d.) for a treatment period of 8 weeks.

Secondary

Mean Changes From Randomisation Baseline in Trough (Morning Pre-dose and Prerescue Bronchodilator) FEF25-75 After 2, 4 and 8-week Treatment Periods

Mean change from randomization baseline in through (morning pre-dose and pre-rescue bronchodilator) Forced expiratory flow between 25% and 75% of vital capacity (FEF 25-75) after 2, 4 and 8-week treatment periods.

Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.

Posted

At baseline and at week 2, 4 and 8.

ID	Title	Description
OG000	Placebo HFA MDI	Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
OG001	BI 54903 22.7µg Bid	2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
OG002	BI 54903 45.5µg Bid	2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) b.i.d.) for a treatment period of 8 weeks.

Secondary

Mean Pre-dose (and Pre-rescue) Peak Expiratory Flow (PEF) as Assessed Via Asthma Monitor (AM2+) in the Morning and Evening, of the Last Week of the 8-week Treatment Period

Mean pre-dose (and pre-rescue) peak expiratory flow (PEF) as assessed via asthma monitor (AM2+) in the morning and evening of the last week of the 8-week treatment period.

Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.

Posted

At week 8.

ID	Title	Description
OG000	Placebo HFA MDI	Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
OG001	BI 54903 22.7µg Bid	2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
OG002	BI 54903 45.5µg Bid	2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) b.i.d.) for a treatment period of 8 weeks.

Secondary

Mean Rescue Medication Use (Daytime and Night-time) as Assessed Via Asthma Monitor (AM2+) in the Morning and Evening, of the Last Week of the 8-week Treatment Period

Mean rescue medication use (daytime and night-time) as assessed via asthma monitor (AM2+) in the morning and evening, of the last week of the 8-week treatment period.

Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.

Posted

At week 8.

ID	Title	Description
OG000	Placebo HFA MDI	Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
OG001	BI 54903 22.7µg Bid	2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
OG002	BI 54903 45.5µg Bid	2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) b.i.d.) for a treatment period of 8 weeks.

Secondary

Mean Change From Randomisation Baseline in Asthma Control Questionnaire (ACQ-6) Scores at Subsequent Study Visits

The Asthma Control Questionnaire (ACQ) consists of 6 patient self-evaluated questions with each question in 7-point scale. The items are equally weighted and the ACQ score is the mean of 6 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of less than or equal to 0.75 indicate well-controlled asthma, scores between 0.76 and less than 1.5 indicate partly controlled asthma, and a score greater than or equal to 1.5 indicates uncontrolled asthma.

Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.

Posted

At baseline and at week 2, 4 and 8.

ID	Title	Description
OG000	Placebo HFA MDI	Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
OG001	BI 54903 22.7µg Bid	2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
OG002

Secondary

Mean Change From Randomisation Baseline in Asthma Quality of Life Questionnaire (AQLQ(S)+12) Scores at Subsequent Study Visits

AQLQ(S)+12 are well established and validated questionnaires to measure control of asthma symptoms and quality of life, which is a patient-reported self-administered outcome questionnaire containing 32 items. Each item is scored on a 7-point scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.

Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.

Posted

At baseline and at week 2, 4 and 8.

ID	Title	Description
OG000	BI 54903 22.7µg Bid	2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
OG001	BI 54903 45.5µg Bid	2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) b.i.d.) for a treatment period of 8 weeks.

Secondary

Time to Withdrawal Due to First Asthma Exacerbation

Time to withdrawal due to first asthma exacerbation.

Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.

Posted

At week 8.

ID	Title	Description
OG000	Placebo HFA MDI	Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
OG001	BI 54903 22.7µg Bid	2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
OG002	BI 54903 45.5µg Bid	2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) b.i.d.) for a treatment period of 8 weeks.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler.)	8	8	3	8
EG001	BI 54903 22.7µg Bid	2 puffs of 11.4 microgram (µg) (total 22.7 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.	5	5	0	5
EG002	BI 54903 45.5µg Bid	2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) b.i.d.) for a treatment period of 8 weeks.	4	4	0	4
EG003	BI 54903 90.9µg Bid	2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.	6	6	1	6
EG004	Fluticasone Propionate 88µg Bid	2 puffs of 44 µg (total 88 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.	6	6	0	6

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Asthma	Respiratory, thoracic and mediastinal disorders	14.1	Systematic Assessment		EG0003 affected8 at risk EG0010 affected5 at risk EG0020 affected4 at risk EG0030 affected6 at risk EG0040 affected6 at risk
Viral upper respiratory tract infection	Infections and infestations	14.1	Systematic Assessment		EG0000 affected8 at risk EG0010 affected5 at risk EG0020 affected4 at risk EG003

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D000730	Androstadienes
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds