Trial of Aeroquin Versus Tobramycin Inhalation Solution (... | NCT01270347

ID	Type	Description	Link
2010-019634-26	EudraCT Number

Status Module

Name	Class
Forest Laboratories	INDUSTRY

Oversight Module

Description 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
Aeroquin	Experimental	Aeroquin, Inhaled Levofloxacin (MP-376)	Drug: MP-376 (Levofloxacin Solution for Inhalation)
TIS	Active Comparator	Tobramycin Inhalation solution (TIS) [TOBI® Novartis Pharmaceuticals]	Drug: TIS (Tobramycin Inhalation Solution)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MP-376 (Levofloxacin Solution for Inhalation)	Drug	MP-376 (Aeroquin, Levofloxacin solution for Inhalation) 240 mg administered BID for 28-days treatment followed by 28 days off treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a Study Drug, whether or not considered related to the Study Drug. An AE could potentially be a new disease, any untoward event, or an exacerbation of a pre-existing condition. AEs included, but were not limited to: Any symptom not previously reported by the patient (medical history) An exacerbation of a pre-existing illness An increase in frequency or intensity of a pre-existing episodic event or condition A condition first detected or diagnosed after Study Drug administration even though the condition may have been present before the start of the study Overdose of Study Drug	From start of study until end of the study (up to 168 days)
Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1)	FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer. Least squares (LS) mean and standard error (SE) were determined from an analysis of covariance model with terms for treatment, region (US, non-US), and age (12 to 18 years, > 18 years), and Baseline FEV1 (< 55%, . 55%).	Baseline, day 28

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Average Expired Flow Over the Middle Half of The FVC Maneuver (FEF25-75)	LSMean and SE were determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, >18 years), baseline FEV1 (<55%, >=55%), and baseline as a covariate.	Baseline, day 28

Eligibility Module

Name	Affiliation	Role
MD	Amgen	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26935334	Derived	Elborn JS, Flume PA, Cohen F, Loutit J, VanDevanter DR. Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. J Cyst Fibros. 2016 Sep;15(5):634-40. doi: 10.1016/j.jcf.2016.01.005. Epub 2016 Feb 28.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tobramycin Inhalation Solution 300 mg/Aeroquin 240 mg	Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment) during core phase. Participants received 240 mg of Aeroquin by inhalation route, BID over 3 consecutive 56-day cycles (28days on treatment and 28 days off treatment) during extension phase.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Tobramycin Inhalation Solution 300 mg	Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
BG001	Levofloxacin Inhalation Solution 240 mg	Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
BG002	Total	Total of all reporting groups

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
	BG00028.9± 11.05 BG00128.3± 9.00 BG00228.5± 9.71

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00037 BG00181 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG00114 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 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

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a Study Drug, whether or not considered related to the Study Drug.

An AE could potentially be a new disease, any untoward event, or an exacerbation of a pre-existing condition. AEs included, but were not limited to:

Any symptom not previously reported by the patient (medical history) An exacerbation of a pre-existing illness An increase in frequency or intensity of a pre-existing episodic event or condition A condition first detected or diagnosed after Study Drug administration even though the condition may have been present before the start of the study Overdose of Study Drug

Safety Population

Posted

Number

participants

From start of study until end of the study (up to 168 days)

ID	Title	Description
OG000	Tobramycin Inhalation Solution 300 mg	Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
OG001	Levofloxacin Inhalation Solution 240 mg	Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).

Units	Counts
Participants	OG00090 OG001182

Title

Denominators

Categories

Title	Measurements
	OG00090 OG001180

Primary

Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1)

FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer. Least squares (LS) mean and standard error (SE) were determined from an analysis of covariance model with terms for treatment, region (US, non-US), and age (12 to 18 years, > 18 years), and Baseline FEV1 (< 55%, . 55%).

Intent-to-treat population included all participants randomized in the study.

Posted

Least Squares Mean

Standard Error

percent predicted FEV1

Baseline, day 28

ID	Title	Description
OG000	Tobramycin Inhalation Solution 300 mg	Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
OG001	Levofloxacin Inhalation Solution 240 mg	Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).

Units	Counts
Participants

Secondary

Percent Change From Baseline in Average Expired Flow Over the Middle Half of The FVC Maneuver (FEF25-75)

LSMean and SE were determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, >18 years), baseline FEV1 (<55%, >=55%), and baseline as a covariate.

ITT Population

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, day 28

ID	Title	Description
OG000	Tobramycin Inhalation Solution 300 mg	Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
OG001	Levofloxacin Inhalation Solution 240 mg	Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Forced Vital Capacity (FVC)

LSMean and SE were determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, >18 years), baseline FEV1 (<55%, >=55%), and baseline as a covariate

ITT Population

Posted

Least Squares Mean

Standard Error

Percent change

Baseline, day 28

ID	Title	Description
OG000	Tobramycin Inhalation Solution 300 mg	Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
OG001	Levofloxacin Inhalation Solution 240 mg	Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).

Units	Counts
Participants	OG000

Secondary

Number of Participants in Each Category of Relative Change in Percent Predicted FEV1

FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer.

ITT population with available data at specified timepoint.

Posted

Number

participants

Day 28

ID	Title	Description
OG000	Tobramycin Inhalation Solution 300 mg	Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
OG001	Levofloxacin Inhalation Solution 240 mg	Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).

Units	Counts
Participants	OG000

Secondary

Number of Participants in Each Category of Percent Change From Baseline in FEV1

FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer.

ITT population with available data.

Posted

Number

participants

Day 28

ID	Title	Description
OG000	Tobramycin Inhalation Solution 300 mg	Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
OG001	Levofloxacin Inhalation Solution 240 mg	Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Pseudomonas Aeruginosa Sputum Density

Pseudomonas aeruginosa density was measured as log10 colony-forming units [CFU] per gram sputum.

ITT population with available data at specified time point

Posted

Least Squares Mean

Standard Error

log10 CFU per gram

Baseline, day 28

ID	Title	Description
OG000	Tobramycin Inhalation Solution 300 mg	Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
OG001	Levofloxacin Inhalation Solution 240 mg	Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).

Units	Counts
Participants	OG000

Secondary

Number of Participants in Each Category of Change From Baseline in Pseudomonas Aeruginosa Sputum Density

Pseudomonas aeruginosa density was measured as log10 colony-forming units [CFU] per gram sputum.

ITT population with available data at specified time point.

Posted

Number

participants

Baseline, day 28

ID	Title	Description
OG000	Tobramycin Inhalation Solution 300 mg	Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
OG001	Levofloxacin Inhalation Solution 240 mg	Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).

Units	Counts
Participants	OG000

Secondary

Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R)

The Cystic Fibrosis Questionnaire (CFQ-R) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF). Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.

ITT population with available data at specified time point.

Posted

Least Squares Mean

Standard Error

Score on a scale

Baseline, day 28

ID	Title	Description
OG000	Tobramycin Inhalation Solution 300 mg	Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
OG001	Levofloxacin Inhalation Solution 240 mg	Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).

Units	Counts
Participants

Secondary

Number of Participants in Each Category of Change From Baseline in the Respiratory Domain of CFQ-R

ITT population with available data at specified time point.

Posted

Number

participants

Baseline, day 28

ID	Title	Description
OG000	Tobramycin Inhalation Solution 300 mg	Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).
OG001	Levofloxacin Inhalation Solution 240 mg	Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment).

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tobramycin Inhalation Solution 300 mg - Core Phase	Participants received 300 mg of Tobramycin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment) during core phase.	90	29	90	88	90
EG001	Aeroquin 240 mg - Core Phase	Participants received 240 mg of Levofloxacin by inhalation route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment) during core phase.	182	40	182	180	182
EG002	Aeroquin 240 mg - Extension Phase	Participants received 240 mg of Aeroquin by inhalation route route, BID over 3 consecutive 56-day cycles (28 days on treatment and 28 days off treatment) during extension phase.	88	22	88	82	88

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Disease progression	General disorders	MedDRA (14.0)	Non-systematic Assessment	EG00035 events24 affected90 at risk EG00139 events31 affected182 at risk EG00218 events16 affected88 at risk
Chest Pain	General disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected182 at risk EG0020 events0 affected88 at risk
Fatigue	General disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected182 at risk EG0020 events0 affected88 at risk
Bronchopneumonia	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0003 events2 affected90 at risk EG0012 events2 affected182 at risk EG0020 events0 affected88 at risk
Pneumonia	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected90 at risk EG0011 events1 affected182 at risk EG0022 events1 affected88 at risk
Chronic sinusitis	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected182 at risk EG0020 events0 affected88 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected182 at risk EG0020 events0 affected88 at risk
Sinusitis	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected182 at risk EG0020 events0 affected88 at risk
Staphylococcal infection	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected182 at risk EG0020 events0 affected88 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected90 at risk EG0011 events1 affected182 at risk EG0020 events0 affected88 at risk
Distal ileal obstruction syndrome	Gastrointestinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0002 events1 affected90 at risk EG0010 events0 affected182 at risk EG0020 events0 affected88 at risk
Constipation	Gastrointestinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected182 at risk EG0020 events0 affected88 at risk
Distal intestinal obstruction syndrome	Gastrointestinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected182 at risk EG0020 events0 affected88 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected182 at risk EG0020 events0 affected88 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected182 at risk EG0020 events0 affected88 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected182 at risk EG0021 events1 affected88 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0002 events2 affected90 at risk EG0011 events1 affected182 at risk EG0020 events0 affected88 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected182 at risk EG0020 events0 affected88 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected182 at risk EG0022 events1 affected88 at risk
Somnolence	Nervous system disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected182 at risk EG0020 events0 affected88 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected182 at risk EG0020 events0 affected88 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected182 at risk EG0020 events0 affected88 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected182 at risk EG0020 events0 affected88 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected90 at risk EG0011 events1 affected182 at risk EG0020 events0 affected88 at risk
Depression	Psychiatric disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected90 at risk EG0010 events0 affected182 at risk EG0020 events0 affected88 at risk
Chest Discomfort	General disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected182 at risk EG0021 events1 affected88 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected182 at risk EG0021 events1 affected88 at risk
Arnold-Chiari malformation	Congenital, familial and genetic disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected182 at risk EG0021 events1 affected88 at risk
Pseudomeningocele	Injury, poisoning and procedural complications	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected182 at risk EG0021 events1 affected88 at risk
Forced expiratory volume decreased	Investigations	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected182 at risk EG0021 events1 affected88 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected90 at risk EG0010 events0 affected182 at risk EG0021 events1 affected88 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0006 affected90 at risk EG0017 affected182 at risk EG0021 affected88 at risk
Nausea	Gastrointestinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0007 affected90 at risk EG00111 affected182 at risk EG0023 affected88 at risk
Disease progression	General disorders	MedDRA (14.0)	Non-systematic Assessment	EG00057 affected90 at risk EG00198 affected182 at risk EG00245 affected88 at risk
Exercise tolerance decreased	General disorders	MedDRA (14.0)	Non-systematic Assessment	EG00014 affected90 at risk EG00123 affected182 at risk EG00211 affected88 at risk
Fatigue	General disorders	MedDRA (14.0)	Non-systematic Assessment	EG00025 affected90 at risk EG00158 affected182 at risk EG00218 affected88 at risk
Malaise	General disorders	MedDRA (14.0)	Non-systematic Assessment	EG0005 affected90 at risk EG0011 affected182 at risk EG0023 affected88 at risk
Pyrexia	General disorders	MedDRA (14.0)	Non-systematic Assessment	EG00010 affected90 at risk EG00117 affected182 at risk EG0026 affected88 at risk
Nasopharyngitis	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG00011 affected90 at risk EG00117 affected182 at risk EG00211 affected88 at risk
Sinusitis	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0008 affected90 at risk EG0018 affected182 at risk EG0023 affected88 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0005 affected90 at risk EG0015 affected182 at risk EG0021 affected88 at risk
Blood glucose increased	Investigations	MedDRA (14.0)	Non-systematic Assessment	EG0007 affected90 at risk EG0014 affected182 at risk EG0020 affected88 at risk
Breath sounds abnormal	Investigations	MedDRA (14.0)	Non-systematic Assessment	EG0001 affected90 at risk EG0011 affected182 at risk EG0025 affected88 at risk
Forced expiratory volume decreased	Investigations	MedDRA (14.0)	Non-systematic Assessment	EG00015 affected90 at risk EG00117 affected182 at risk EG00214 affected88 at risk
Pulmonary function test decreased	Investigations	MedDRA (14.0)	Non-systematic Assessment	EG0008 affected90 at risk EG00114 affected182 at risk EG0028 affected88 at risk
Weight decreased	Investigations	MedDRA (14.0)	Non-systematic Assessment	EG00036 affected90 at risk EG00157 affected182 at risk EG00235 affected88 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (14.0)	Non-systematic Assessment	EG00016 affected90 at risk EG00123 affected182 at risk EG00210 affected88 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Non-systematic Assessment	EG0005 affected90 at risk EG00110 affected182 at risk EG0024 affected88 at risk
Dysgeusia	Nervous system disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 affected90 at risk EG00146 affected182 at risk EG00212 affected88 at risk
Headache	Nervous system disorders	MedDRA (14.0)	Non-systematic Assessment	EG0006 affected90 at risk EG00111 affected182 at risk EG0023 affected88 at risk
Sinus headache	Nervous system disorders	MedDRA (14.0)	Non-systematic Assessment	EG00013 affected90 at risk EG00135 affected182 at risk EG00212 affected88 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG00048 affected90 at risk EG001105 affected182 at risk EG00240 affected88 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0005 affected90 at risk EG0018 affected182 at risk EG0024 affected88 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG00015 affected90 at risk EG00121 affected182 at risk EG00215 affected88 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0005 affected90 at risk EG0012 affected182 at risk EG0020 affected88 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG00017 affected90 at risk EG00129 affected182 at risk EG00212 affected88 at risk
Increased viscosity of bronchial secretion	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG00028 affected90 at risk EG00159 affected182 at risk EG00221 affected88 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0002 affected90 at risk EG00114 affected182 at risk EG0024 affected88 at risk
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG00018 affected90 at risk EG00149 affected182 at risk EG00214 affected88 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0008 affected90 at risk EG0018 affected182 at risk EG0027 affected88 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG00032 affected90 at risk EG00168 affected182 at risk EG00232 affected88 at risk
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG00016 affected90 at risk EG00126 affected182 at risk EG0028 affected88 at risk
Sputum increased	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG00040 affected90 at risk EG00195 affected182 at risk EG00237 affected88 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (14.0)	Non-systematic Assessment	EG0007 affected90 at risk EG0016 affected182 at risk EG0024 affected88 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama	36608	United States

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

ID	Term
D015656	Respiratory Mechanics
D012119	Respiration
D012143	Respiratory Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena