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Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients

NCT ID: NCT03341741

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-11

Study Completion Date

2016-11-25

Brief Summary

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To assess whether the inhalative combination of Tobramycin/Colistin is more effective in reducing Pseudomonas colony forming units (CFUs) and improvement of lung function than Colistin in mono-therapy.

Detailed Description

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Cystic fibrosis (CF), the most common autosomal recessive disorder in Western countries, is caused by mutations of the cystic fibrosis transmembrane conductance regulator molecule (CFTR) and affects approximately 40.000 patients in Europe. The majority of CF patients develop chronic pulmonary infections with Pseudomonas aeruginosa. These are normally treated with single antibiotics, administered orally, intravenously or inhalatively. Once the infection becomes chronic, eradication of the pathogen is not any more possible due to biofilm formation of the pathogen and increasing resistance. However, inhalative antibiotic combination therapy might be more efficient than single antibiotic therapy in chronically infected CF patients. This notion is supported by previous in vitro and animal studies using Tobramycin/Colistin combination therapy. Importantly, a pilot study in five CF patients who inhaled consecutively Colistin and Tobramycin solutions for 4 week, revealed a decrease of log10 2.52 ± 2.5 cfu of P. aeruginosa in sputum specimens during the course of the treatment compared to baseline values (p=0.027). The treatment was shown to be safe and well tolerated. However, forced expiratory volume in 1 sec (FEV1) did not differ significantly.

Taking advantage of the new development of dry powder inhalation (DPI) antibiotics, specifically TOBI© Podhaler, a larger randomised trial has been performed in which the combined TOBI© Podhaler and Colistin treatment is compared to the monotherapy with Colistin.

Conditions

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Cystic Fibrosis With Pulmonary Manifestations

Keywords

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chronic pulmonary infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, open label clinical study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tobramycin powder / Colistin

TOBI®Podhaler 2 x 112 mg daily for 2 x 28 days (on/off); and Colistin solution 2 x daily 1 Mega continuously for 112 days

Group Type EXPERIMENTAL

Tobramycin Powder

Intervention Type DRUG

TOBI®Podhaler 2 x 112 mg daily for 2 x 28 days (on/off);

Colistin

Intervention Type DRUG

Colistin solution 2 x daily 1 Mega continuously

Colistin

Colistin solution 2 x daily 1 Mega continuously for at least 30 days

Group Type ACTIVE_COMPARATOR

Colistin

Intervention Type DRUG

Colistin solution 2 x daily 1 Mega continuously

Interventions

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Tobramycin Powder

TOBI®Podhaler 2 x 112 mg daily for 2 x 28 days (on/off);

Intervention Type DRUG

Colistin

Colistin solution 2 x daily 1 Mega continuously

Intervention Type DRUG

Other Intervention Names

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TOBI®Podhaler Colistin solution

Eligibility Criteria

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Inclusion Criteria

1. Cystic Fibrosis is verified;
2. Patient is 12 years or older;
3. FEV1 is higher than 25% and lower than 100%;
4. The patients' lung is colonised with P. aeruginosa chronically (≥6 months);
5. P. aeruginosa must be sensitive for Tobramycin or Colistin;
6. Pretreated with Colistin \>2 months;
7. Last i.v. antibiotic treatment ≥2 weeks;
8. Informed consent is given by patients/legal representatives

Exclusion Criteria

1. Clinical deterioration is present (exacerbation symptoms);
2. Last Tobramycin inhalation treatment ≤ 2 weeks;
3. Renal dysfunction (creatinine \<1.5 fold of normal, glomerular filtration rate (GFR) \<80%) at baseline
4. auditoria or vestibular dysfunction, hearing loss
5. Intolerances against Tobramycin, Colistin or Polymyxin B
6. Myasthenia gravis
7. Porphyria
8. Pregnancy and nursing
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Coto V3.0

Identifier Type: -

Identifier Source: org_study_id