NCT00918957 - A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions

Cystic Fibrosis

Interventions

DRUG

Tobramycin Inhalation Powder

Tobramycin Inhalation Powder as produced by a modified manufacturing process TIP. TIP was provided in hard capsules each containing 28 mg active ingredient (tobramycin); Capsules were packaged in blister cards and administered by the T-326 Inhaler.

DRUG

Placebo

Placebo inhalation powder consisting of the excipients used for TIP. Placebo was provided in hard capsules, containing 20 mg placebo powder, which were packaged in blister cards, matching in appearance to TIP. Capsules were administered by the T-326 Inhaler.

Trial Locations (24)

Unknown

Novartis Investigative Site, Pleven

Novartis Investigative Site, Plovdiv

Novartis Investigative Site, Sofia

Novartis Investigative Site, Varna

Novartis Investigative Site, Alexandria

Novartis Investigative Site, Giza

Novartis Investigative Site, Tallinn

Novartis Investigative Site, Tartu

Novartis Investigative Site, Chandigarh

Novartis Investigative Site, Hyderabad

Novartis Investigative Site, New Delhi

Novartis Investigative Site, Vellore

Novartis Investigative Site, Riga

Novartis Investigative Site, Kaunas

Novartis Investigative Site, Vilnius

Novartis Investigative Site, Bucharest

Novartis Investigative Site, Timișoara

Novartis Investigative Site, Kazan'

Novartis Investigative Site, Moscow

Novartis Investigative Site, Saint Petersburg

Novartis Investigative Site, Samara

Novartis Investigative Site, Voronezh

Novartis Investigator Site, Yaroslavi

Novartis Investigative Site, Durban