Study for Evaluating the Real Use of Inhaled Aztreonam Ly... | NCT03607396

Studies
Study for Evaluating the Real Use of Inhaled Aztreonam Lysine in Patients With Cystic Fibrosis

NCT03607396

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Status

Unknown status

Last Update Posted

Jul 31, 2018Actual

Enrollment

75Estimated

Phase

Not provided

Conditions

Cystic Fibrosis

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Jul 1, 2019Estimated

Completion Date

Jul 1, 2019Estimated

First Submitted Date

Jul 23, 2018

First Submission Date that Met QC Criteria

Jul 23, 2018

First Posted Date

Jul 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2018

Last Update Posted Date

Jul 31, 2018Actual

Name	Class
Gilead Sciences	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this observational trial is to evaluate the pulmonary function in cystic fibrosis patients that have been treated with inhaled aztreonam lysine comparing the previous 12 months before the treatment and the forward 12 months after initiating the treatment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
FEV1	Forced expiratory volume in one second (FEV1) measured during pulmonary function test.	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients above 6 years old that have been treated with Aztreonam Lysine (AZLI) at any time within 12 months before starting the treatment
Diagnosis of Cystic Fibrosis confirmed
Chronic infection by Pseudomonas aeruginosa
Patients can be treated with any inhaled antibiotic before or after AZLI treatment
Patients have to have the following FEV1 measures: 12 months before starting AZLI; at AZLI initiation; 12 months after starting AZLI
For lung transplant patiens, only data before the transplant will be collected.

Exclusion Criteria:

Non applicable

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Cystic fibrosis patients colonized by Pseudomonas aeruginosa

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Olga SanchezMaroto	Contact	934893000		olga.sanchez-maroto@vhir.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Vall d'Hebron	Recruiting	Barcelona	Catalonia	08035	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided