An Exploratory Study to Assess Multiple Doses of Omalizum... | NCT00787917

NCT00787917

Status Module

Sponsor/Collaborators Module

Oversight Module

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No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omalizumab	Experimental	Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg. Participants who completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.	Drug: Omalizumab Drug: Itraconazole
Placebo	Placebo Comparator	Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.	Drug: Placebo Drug: Itraconazole

Name	Type	Description	Arm Group Labels	Other Names
Omalizumab	Drug	Omalizumab subcutaneous injections of 600 mg daily.	Omalizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline, as Measured by the Percentage of Participants Requiring Rescue With Corticosteroids, and as Measured by the Time to Deviation From the Protocol Prescribed Steroid Tapering Regimen		6 months of blinded treatment

Secondary Outcomes

Measure	Description	Time Frame
Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period		6 months, 12 months
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline, Measured at 3 and 6 Months of Treatment

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis	Novartis Investigator Site	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigator Site		Leuven			Belgium
Novartis Investigator Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26302738	Derived	Beam KT, Coop CA. Steroid sparing effect of omalizumab in seropositive allergic bronchopulmonary aspergillosis. Allergy Rhinol (Providence). 2015 Jan;6(2):143-5. doi: 10.2500/ar.2015.6.0128.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Omalizumab	Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg. Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Omalizumab	Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg. Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.
BG001	Placebo	Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0009 BG0015 BG00214

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
Female	BG0005 BG0011 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

Change From Baseline, as Measured by the Percentage of Participants Requiring Rescue With Corticosteroids, and as Measured by the Time to Deviation From the Protocol Prescribed Steroid Tapering Regimen

No statistical analysis was performed due to insufficient study enrollment

Posted

Least Squares Mean

Standard Error

percentage

6 months of blinded treatment

ID	Title	Description
OG000	Omalizumab	Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
OG001	Placebo	Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.

Units	Counts
Participants	OG0000 OG0010

Secondary

Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period

No statistical analysis was performed due to insufficient study enrollment

Posted

Least Squares Mean

Standard Error

percentage

6 months, 12 months

ID	Title	Description
OG000	Omalizumab	Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg. Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.
OG001	Placebo	Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.

Secondary

Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline, Measured at 3 and 6 Months of Treatment

No statistical analysis was performed due to insufficient study enrollment

Posted

Least Squares Mean

Standard Error

Liters

3 months, 6 months

ID	Title	Description
OG000	Omalizumab	Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
OG001	Placebo	Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.

Secondary

Time to Steroid Free State.

No statistical analysis was performed due to insufficient study enrollment

Posted

Mean

Standard Deviation

days

12 months

ID	Title	Description
OG000	Omalizumab	Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg. Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.
OG001	Placebo	Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.

Secondary

Change From Baseline in Average Oral Corticosteroid Use.

No statistical analysis was performed due to insufficient study enrollment

Posted

Mean

Standard Deviation

mg/day

6 months, 12 months

ID	Title	Description
OG000	Omalizumab	Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg. Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.
OG001	Placebo	Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.

Secondary

Percentage of Participants Responding to Omalizumab, as Defined by a Reduction in Oral Corticosteroid Dose Use of 50% or More as Compared to Baseline

No statistical analysis was performed due to insufficient study enrollment

Posted

Least Squares Mean

Standard Error

percentage of participants

6 months, 12 months

ID	Title	Description
OG000	Omalizumab	Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg. Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.
OG001	Placebo	Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Blinded Omalizumab	Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.	6	9	9	9
EG001	Placebo	Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.	1	5	5	5
EG002	Open Label Omalizumab	Patients who completed double-blinded phase of the study, enrolled into 6 months open label phase and continued in the same regimen of omalizumab as they were during double-blinded phase. A maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.	4	7	6	7

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Distal intestinal obstruction syndrome	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Bronchopulmonary aspergillosis allergic	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Infective pulmonary exacerbation of cystic fibrosis	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected9 at risk EG0011 affected5 at risk EG0024 affected7 at risk
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cystic fibrosis lung	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0011 affected5 at risk EG0020 affected7 at risk
Conjunctivitis	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0011 affected5 at risk EG0020 affected7 at risk
Retinopathy hypertensive	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0011 affected5 at risk EG0023 affected7 at risk
Chills	General disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0011 affected5 at risk EG0020 affected7 at risk
Device occlusion	General disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Exercise tolerance decreased	General disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Influenza like illness	General disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Injection site erythema	General disorders	MedDRA	Systematic Assessment	EG0003 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Injection site inflammation	General disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Injection site pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Injection site swelling	General disorders	MedDRA	Systematic Assessment	EG0004 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Injection site warmth	General disorders	MedDRA	Systematic Assessment	EG0004 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Medical device pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0011 affected5 at risk EG0021 affected7 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0003 affected9 at risk EG0012 affected5 at risk EG0022 affected7 at risk
Vessel puncture site haematoma	General disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Food allergy	Immune system disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0011 affected5 at risk EG0020 affected7 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0011 affected5 at risk EG0020 affected7 at risk
Infective pulmonary exacerbation of cystic fibrosis	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected9 at risk EG0014 affected5 at risk EG0023 affected7 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Lung infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0011 affected5 at risk EG0020 affected7 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected9 at risk EG0010 affected5 at risk EG0022 affected7 at risk
Oral candidiasis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Oral herpes	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Pseudomonas infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0011 affected5 at risk EG0020 affected7 at risk
Respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0011 affected5 at risk EG0020 affected7 at risk
Blood glucose increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Blood sodium decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Liver function test abnormal	Investigations	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected9 at risk EG0010 affected5 at risk EG0022 affected7 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Vitamin K deficiency	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0011 affected5 at risk EG0020 affected7 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 affected9 at risk EG0011 affected5 at risk EG0023 affected7 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0011 affected5 at risk EG0020 affected7 at risk
Bronchostenosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected9 at risk EG0011 affected5 at risk EG0023 affected7 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0011 affected5 at risk EG0020 affected7 at risk
Sputum increased	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0011 affected5 at risk EG0022 affected7 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0011 affected5 at risk EG0020 affected7 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0011 affected5 at risk EG0020 affected7 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected9 at risk EG0010 affected5 at risk EG0020 affected7 at risk
Flushing	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected9 at risk EG0010 affected5 at risk EG0021 affected7 at risk

ID	Term
D003550	Cystic Fibrosis
D001229	Aspergillosis, Allergic Bronchopulmonary

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007232	Infant, Newborn, Diseases
D055732	Pulmonary Aspergillosis
D001228	Aspergillosis
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections
D008172	Lung Diseases, Fungal
D012141	Respiratory Tract Infections
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D000069444	Omalizumab
D017964	Itraconazole

Ancestor Terms

ID	Term
D000888	Antibodies, Anti-Idiotypic
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D012712	Serum Globulins
D005916	Globulins
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D010879	Piperazines

Units	Counts
Participants	OG0000 OG0010