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Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis

NCT ID: NCT01460836

Last Updated: 2011-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Brief Summary

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Matching-adjusted indirect comparison of tobramycin solution (TIS) versus aztreonam lysine (AZLI) using TIS patient level clinical trial data and AZLI aggregated clinical trial data from published literature.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Tobramycin Solution

Tobramycin solution for inhalation

Intervention Type DRUG

Aztreonam lysine

Aztreonam lysine for inhalation

Intervention Type DRUG

Interventions

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Tobramycin solution for inhalation

Intervention Type DRUG

Aztreonam lysine for inhalation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥ 6 years of age with a documented Cystic fibrosis (CF) diagnosis,
* moderate-to severe lung disease,
* the ability to perform reproducible pulmonary function tests,
* Pseudomonas aeruginosa (PA) airway infection.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

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HEORUS0017

Identifier Type: -

Identifier Source: org_study_id