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AZLI

Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species Infection

Ensayo de GILEAD SCIENCES, INC. en Cystic Fibrosis · Burkholderia Infections (del registro, en inglés).

Más ensayos de: Fibrosis quística.

Fase

Fase 3

Estado

Completado

Participantes

102

previstos

Centros

35

Fin del objetivo primario

sep 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en feb 2010.

Qué mide

AUCave of Relative Change in FEV1 % Predicted From Baseline to Week 24 (del registro, en inglés) (del inicio a la semana 24)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this research study was to determine if an experimental drug called Aztreonam for Inhalation Solution (AZLI) was safe and effective to treat Burkholderia lung infections in patients with cystic fibrosis (CF). Spirometry was used to assess pulmonary function, and the revised Cystic Fibrosis Questionnaire (CFQ-R) was used to assess quality of life. The CFQ-R is a validated, patient-reported outcome tool used to measure health-related quality of life for children and adults with CF. The study consisted of a 24-week randomized phase, and a 24-week open-label phase. Primary and secondary efficacy analyses were conducted for the 24-week randomized phase only. Safety data were collected for both the randomized and open-label phases.

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01059565), actualizada en feb 2014.