Safety and Effectiveness of AZLI (an Inhaled Antibiotic)... | NCT01313624

Status Module

Label	Type	Description	Intervention Names
AZLI-AZLI	Experimental	Participants were randomized to receive blinded AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up.	Drug: AZLI
Placebo-AZLI	Placebo Comparator	Participants were randomized to receive blinded placebo to match AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up.	Drug: AZLI Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AZLI	Drug	AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily	AZLI-AZLI Placebo-AZLI

Measure	Description	Time Frame
Change in QOL-B Respiratory Symptoms Score at Day 28	The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.	Baseline to Day 28

Measure	Description	Time Frame
Change in QOL-B Respiratory Symptoms Score at Day 84	The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.	Baseline to Day 84

Eligibility Module

Name	Affiliation	Role
Alan Barker, MD	Oregon Health and Science University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Pulmonary Associates		Phoenix	Arizona	85006	United States
Arizona Pulmonary Specialists, LTD

PubMed Identifier	Type	Citation	Retractions
25154045	Derived	Barker AF, O'Donnell AE, Flume P, Thompson PJ, Ruzi JD, de Gracia J, Boersma WG, De Soyza A, Shao L, Zhang J, Haas L, Lewis SA, Leitzinger S, Montgomery AB, McKevitt MT, Gossage D, Quittner AL, O'Riordan TG. Aztreonam for inhalation solution in patients with non-cystic fibrosis bronchiectasis (AIR-BX1 and AIR-BX2): two randomised double-blind, placebo-controlled phase 3 trials. Lancet Respir Med. 2014 Sep;2(9):738-49. doi: 10.1016/S2213-2600(14)70165-1. Epub 2014 Aug 18.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	AZLI-AZLI	Participants were randomized to receive blinded Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.

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

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00064.2± 12.92 BG00164.9± 12.11 BG00264.6± 12.51

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00084 BG00197 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00012 BG00111 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White

Title	Measurements
	BG000121 BG001119 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00086 BG00179 BG002

QOL-B Respiratory Symptom Score

The Quality of Life Questionnaire-Bronchiectasis (QOL-B) overall score was scaled from 0-100 with higher scores representing better quality of life.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00055.0± 19.32 BG001

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 in QOL-B Respiratory Symptoms Score at Day 28

The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.

Participants in the ITT Analysis Set with scores at both baseline and Day 28 were analyzed.

Posted

Mean

Standard Deviation

units on a scale

Baseline to Day 28

ID	Title	Description
OG000	AZLI-AZLI	Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
OG001	Placebo-AZLI	Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.

Units	Counts
Participants	OG000117 OG001124

Title

Denominators

Categories

Title	Measurements
	OG0007.4± 21.37 OG0015.7± 13.62

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		MMRM		0.68	P-value was based on T-test from mixed-effect model repeated measures (MMRM).	Difference in least squares mean	0.8			2-Sided	95	-3.1	4.7				No	Superiority or Other

Secondary

Change in QOL-B Respiratory Symptoms Score at Day 84

The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.

Participants in the ITT Analysis Set with scores at both baseline and Day 84 were analyzed.

Posted

Mean

Standard Deviation

units on a scale

Baseline to Day 84

ID	Title	Description
OG000	AZLI-AZLI	Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
OG001	Placebo-AZLI	Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.

Units	Counts

Secondary

Time to Protocol-Defined Exacerbation (PDE)

Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria.

Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough
Minor Criteria: fever (> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased > 10% from baseline; new or increased hemoptysis

ITT Analysis Set

Posted

Median

95% Confidence Interval

days

Baseline to Day 112

ID	Title	Description
OG000	AZLI-AZLI	Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
OG001	Placebo-AZLI	Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AZLI-AZLI (Double-Blind)	Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.	28	134	116	134
EG001	Placebo-AZLI (Double-Blind)	Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind placebo; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.	13	132	102	132
EG002	AZLI-AZLI (Open-Label)	Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.	9	96	54	96
EG003	Placebo-AZLI (Open-Label)	Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.	18	122	76	122

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0005 affected134 at risk EG0014 affected132 at risk EG0025 affected96 at risk EG0037 affected122 at risk
Pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0005 affected134 at risk EG0011 affected132 at risk EG0022 affected96 at risk EG003
Bronchitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Lung infection pseudomonal	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Infected skin ulcer	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Sinusitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected134 at risk EG0010 affected132 at risk EG0021 affected96 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Sputum increased	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0011 affected132 at risk EG0021 affected96 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Orthostatic intolerance	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Dizziness	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Pyrexia	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Gait disturbance	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Electrocardiogram abnormal	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0011 affected132 at risk EG0020 affected96 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0010 affected132 at risk EG0021 affected96 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0010 affected132 at risk EG0021 affected96 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0010 affected132 at risk EG0021 affected96 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Type IV hypersensitivity reaction	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected134 at risk EG0010 affected132 at risk EG0020 affected96 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00069 affected134 at risk EG00157 affected132 at risk EG00235 affected96 at risk EG00350 affected122 at risk
Sputum Increased	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00062 affected134 at risk EG00148 affected132 at risk EG00229 affected96 at risk EG003
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00042 affected134 at risk EG00133 affected132 at risk EG00224 affected96 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0008 affected134 at risk EG00112 affected132 at risk EG0025 affected96 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00073 affected134 at risk EG00147 affected132 at risk EG00231 affected96 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00014 affected134 at risk EG00117 affected132 at risk EG0024 affected96 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0006 affected134 at risk EG0017 affected132 at risk EG0020 affected96 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 affected134 at risk EG0017 affected132 at risk EG0020 affected96 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00021 affected134 at risk EG00114 affected132 at risk EG0026 affected96 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00010 affected134 at risk EG0017 affected132 at risk EG0020 affected96 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00014 affected134 at risk EG0013 affected132 at risk EG0026 affected96 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0007 affected134 at risk EG0017 affected132 at risk EG0020 affected96 at risk EG003
Fatigue	General disorders	MedDRA 15.1	Systematic Assessment	EG00056 affected134 at risk EG00129 affected132 at risk EG00222 affected96 at risk EG003
Malaise	General disorders	MedDRA 15.1	Systematic Assessment	EG00011 affected134 at risk EG00114 affected132 at risk EG0025 affected96 at risk EG003
Pyrexia	General disorders	MedDRA 15.1	Systematic Assessment	EG00032 affected134 at risk EG00116 affected132 at risk EG0027 affected96 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG00020 affected134 at risk EG00114 affected132 at risk EG0026 affected96 at risk EG003
Chills	General disorders	MedDRA 15.1	Systematic Assessment	EG00018 affected134 at risk EG0016 affected132 at risk EG0026 affected96 at risk EG003
Oedema peripheral	General disorders	MedDRA 15.1	Systematic Assessment	EG0007 affected134 at risk EG0016 affected132 at risk EG0020 affected96 at risk EG003
Headache	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG00021 affected134 at risk EG00123 affected132 at risk EG0025 affected96 at risk EG003
Sinus headache	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0008 affected134 at risk EG0012 affected132 at risk EG0020 affected96 at risk EG003
Dizziness	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG00010 affected134 at risk EG0016 affected132 at risk EG0020 affected96 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00013 affected134 at risk EG00111 affected132 at risk EG0020 affected96 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0007 affected134 at risk EG0016 affected132 at risk EG0020 affected96 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00010 affected134 at risk EG00112 affected132 at risk EG0020 affected96 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0008 affected134 at risk EG0015 affected132 at risk EG0020 affected96 at risk EG003

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description
BG000	AZLI-AZLI	Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
BG001	Placebo-AZLI	Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
BG002	Total	Total of all reporting groups