CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 62 enrolled
Drug / intervention
Tobramycin Inhalation Powder +1 moredrug
Likely dose
Tobramycin Inhalation Powder 28 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00918957
NCT00918957Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew).

Novartis Pharmaceuticals·interventional·Posted Jun 11, 2009·Updated Oct 3, 2012

In Brief

A Phase 3 clinical trial evaluating Tobramycin Inhalation Powder and Placebo for Cystic Fibrosis. Completed, enrolled 62 participants across 24 sites in 9 countries.

Detailed Summary

This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesBulgaria, Egypt, Estonia, India, Latvia, Lithuania, Romania, Russia, South Africa
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 11, 2009
Enrollment StartJun 1, 2009
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.1 years ago

Interventions

Tobramycin Inhalation Powderdrug

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.

Placebodrug

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.