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Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years (EARLY)

Primary Purpose

Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TOBI
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients focused on measuring Tobramycin Inhalation solution, Cystic fibrosis, Lung disease, anti-bacterial agents

Eligibility Criteria

3 Months - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of cystic fibrosis
  • Early lower respiratory tract infection with P. aeruginosa,

Exclusion Criteria:

  • Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
  • Administration of loop diuretics within 7 days prior to study drug administration.
  • Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TOBI (tobramycin inhaled solution)/Placebo

Placebo/TOBI

Arm Description

Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle).

Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle).

Outcomes

Primary Outcome Measures

Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle
Sputum/throat swab cultures were assessed.

Secondary Outcome Measures

Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle
Sputum/throat swab cultures were assessed.
Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period
Sputum/throat swab cultures were assessed.

Full Information

First Posted
March 5, 2010
Last Updated
June 6, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01082367
Brief Title
Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
Acronym
EARLY
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients
Keywords
Tobramycin Inhalation solution, Cystic fibrosis, Lung disease, anti-bacterial agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TOBI (tobramycin inhaled solution)/Placebo
Arm Type
Experimental
Arm Description
Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle).
Arm Title
Placebo/TOBI
Arm Type
Placebo Comparator
Arm Description
Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle).
Intervention Type
Drug
Intervention Name(s)
TOBI
Intervention Description
TOBI (tobramycin inhaled solution)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle
Description
Sputum/throat swab cultures were assessed.
Time Frame
Day 29
Secondary Outcome Measure Information:
Title
Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle
Description
Sputum/throat swab cultures were assessed.
Time Frame
Day 91
Title
Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period
Description
Sputum/throat swab cultures were assessed.
Time Frame
Day 91

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of cystic fibrosis Early lower respiratory tract infection with P. aeruginosa, Exclusion Criteria: Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics. Administration of loop diuretics within 7 days prior to study drug administration. Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1C5
Country
Canada
Facility Name
Novartis Investigative Site
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Novartis Investigative Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Thessaloniki
State/Province
GR
ZIP/Postal Code
546 29
Country
Greece
Facility Name
Novartis Investigative Site
City
Thessaloniki
State/Province
GR
ZIP/Postal Code
546 42
Country
Greece
Facility Name
Novartis Investigative Site
City
Patras
ZIP/Postal Code
265 00
Country
Greece
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Novartis Investigative Site
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20122
Country
Italy
Facility Name
Novartis Investigative Site
City
Bucuresti
ZIP/Postal Code
20395
Country
Romania
Facility Name
Novartis Investigative Site
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Voronezh
ZIP/Postal Code
394036
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29685813
Citation
Ratjen F, Moeller A, McKinney ML, Asherova I, Alon N, Maykut R, Angyalosi G; EARLY study group. Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study. J Cyst Fibros. 2019 Jan;18(1):78-85. doi: 10.1016/j.jcf.2018.04.002. Epub 2018 Apr 21.
Results Reference
derived

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Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years

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