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NCT01460836 Clinical Trial

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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01460836
Other study ID # HEORUS0017
Secondary ID
Status Completed
Phase N/A
First received October 25, 2011
Last updated October 26, 2011
Start date April 2010

Study information
Verified date October 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 6 Years and older
Eligibility 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.

Exclusion Criteria:

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• Tobramycin solution for inhalation

• Aztreonam lysine for inhalation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Outcome
Type Measure Description Time frame Safety issue
Primary Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baseline Baseline, Weeks 2, 4 and 6 No
Secondary Mean change in the density of Pseudomonas aeruginosa (PA) from baseline Baseline, Weeks 2, 4 and 6 No
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