Clinical Trial Results:
Ensayo clínico piloto, aleatorizado, controlado con placebo, paralelo, para evaluar la eficacia y seguridad de la tobramicina inhalada, en el paciente afecto de bronquiectasias, sin fibrosis quística e infección bronquial intermitente por Pseudomonas aeruginosa.
Summary
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EudraCT number |
2005-005820-15 |
Trial protocol |
ES |
Global end of trial date |
31 Dec 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Nov 2021
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First version publication date |
13 Nov 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ORRI-4
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
VHIR
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Sponsor organisation address |
Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
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Public contact |
Joaquin Lopez-Soriano, VHIR, joaquin.lopez.soriano@vhir.org
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Scientific contact |
Ramon Orriols, VHIR, raorriols.girona.ics@gencat.cat
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Dec 2013
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Dec 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Determinar si ell uso de tobramicina inhalada en los sujetos afectos de bronquiectasias e infección inicial o intermitente por Pseudomonas aeruginosa evita o retrasa la aparición de un nuevo cultivo positivo a Pseudomonas aeruginosa y aumenta el tiempo libre de exacerbaciones secundarias a Pseudomonas aeruginosa.
To evaluate the efficacy of 3 months of nebulised tobramycin after a short course of intravenous antibiotics in the eradication of P. aeruginosa and its clinical consequences in nonCF bronchiectasis following initial P. aeruginosa infection.
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Protection of trial subjects |
During the 3 first months, all patients were controlled monthly and 5, 7, 9, 12 and 15 months thereafter. The number of exacerbations, number of hospital admissions and days of hospitalisation were registered. Supplementary use of oral antibiotics was allowed on the development of an exacerbation, defined as more frequent coughing, greater dyspnoea and an increase in sputum volume and purulence
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Mar 2006
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 35
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Worldwide total number of subjects |
35
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EEA total number of subjects |
35
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
35
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
Pre-assignment
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Screening details |
- | ||||||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
35 | ||||||||||||||||||
Number of subjects completed |
35 | ||||||||||||||||||
Period 1
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Period 1 title |
Tobramycin (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Tobramycin | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Tobramycin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Nebuliser solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
300 mg twice daily for 3 months, nebulized solution for inhalatiom
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Arm title
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Placebo | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Saline 0.9%
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Nebuliser solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
Twice daily during 3 motnhs, volumes equivalent to experimental group
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Baseline characteristics reporting groups
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Reporting group title |
Tobramycin
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Tobramycin
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Reporting group description |
- | ||
Reporting group title |
Placebo
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Reporting group description |
- |
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End point title |
Ps aeruginosa in sputum | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
End of study (15 months)
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Statistical analysis title |
P aeruginosa in sputum | ||||||||||||
Comparison groups |
Tobramycin v Placebo
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Number of subjects included in analysis |
28
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
P-value |
= 0.048 | ||||||||||||
Method |
Fisher exact | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
15 months
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Assessment type |
Systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
14.1
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Reporting groups
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Reporting group title |
Total adverse events
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Reporting group description |
- | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Nebulised tobramycin therapy had to be discontinued due to bronchospasm in 5 patients, suggesting that the risk of this complication should be considered in patients with low FEV1 values. Larger number of patients and longer follow-up are desired | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/26340658 |