Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years (EARLY)
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| ClinicalTrials.gov Identifier: NCT01082367 |
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Recruitment Status :
Completed
First Posted : March 8, 2010
Results First Posted : April 27, 2016
Last Update Posted : July 15, 2016
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients | Drug: TOBI Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years |
| Study Start Date : | April 2010 |
| Actual Primary Completion Date : | June 2015 |
| Actual Study Completion Date : | June 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
| Arm | Intervention/treatment |
|---|---|
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Experimental: TOBI (tobramycin inhaled solution)/Placebo
Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle).
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Drug: TOBI
TOBI (tobramycin inhaled solution) Drug: Placebo Placebo |
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Placebo Comparator: Placebo/TOBI
Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle).
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Drug: TOBI
TOBI (tobramycin inhaled solution) Drug: Placebo Placebo |
Primary Outcome Measures :
- Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle [ Time Frame: Day 29 ]Sputum/throat swab cultures were assessed.
Secondary Outcome Measures :
- Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle [ Time Frame: Day 91 ]Sputum/throat swab cultures were assessed.
- Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period [ Time Frame: Day 91 ]Sputum/throat swab cultures were assessed.
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| Ages Eligible for Study: | 3 Months to 6 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of cystic fibrosis
- Early lower respiratory tract infection with P. aeruginosa,
Exclusion Criteria:
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- Administration of loop diuretics within 7 days prior to study drug administration.
- Other protocol-defined inclusion/exclusion criteria may apply
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082367
Locations
| Canada, Ontario | |
| Novartis Investigative Site | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Canada, Quebec | |
| Novartis Investigative Site | |
| Montreal, Quebec, Canada, H3T1C5 | |
| Egypt | |
| Novartis Investigative Site | |
| Alexandria, Egypt, 21131 | |
| France | |
| Novartis Investigative Site | |
| Bordeaux, France, 33076 | |
| Novartis Investigative Site | |
| Paris, France, 75019 | |
| Germany | |
| Novartis Investigative Site | |
| Dresden, Germany, 01307 | |
| Greece | |
| Novartis Investigative Site | |
| Thessaloniki, GR, Greece, 546 29 | |
| Novartis Investigative Site | |
| Thessaloniki, GR, Greece, 546 42 | |
| Novartis Investigative Site | |
| Patras, Greece, 265 00 | |
| Hungary | |
| Novartis Investigative Site | |
| Debrecen, Hungary, 4032 | |
| Novartis Investigative Site | |
| Debrecen, Hungary, 4043 | |
| Novartis Investigative Site | |
| Kaposvar, Hungary, 7400 | |
| Novartis Investigative Site | |
| Szeged, Hungary, 6725 | |
| Italy | |
| Novartis Investigative Site | |
| Milano, MI, Italy, 20122 | |
| Romania | |
| Novartis Investigative Site | |
| Bucuresti, Romania, 20395 | |
| Russian Federation | |
| Novartis Investigative Site | |
| Kazan, Russian Federation, 420012 | |
| Novartis Investigative Site | |
| Voronezh, Russian Federation, 394036 | |
| Novartis Investigative Site | |
| Yaroslavl, Russian Federation, 150003 | |
| Switzerland | |
| Novartis Investigative Site | |
| Zürich, Switzerland, 8032 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01082367 |
| Other Study ID Numbers: |
CTBM100C2304 2009-016590-15 ( EudraCT Number ) |
| First Posted: | March 8, 2010 Key Record Dates |
| Results First Posted: | April 27, 2016 |
| Last Update Posted: | July 15, 2016 |
| Last Verified: | June 2016 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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Tobramycin Inhalation solution Cystic fibrosis Lung disease anti-bacterial agents |
Additional relevant MeSH terms:
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Infections Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases |
Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |