Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients

NCT03341741 | Completed Phase 3

• 1 other identifier: Coto V3.0
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cystic Fibrosis With Pulmonary Manifestations

Keywords

chronic pulmonary infection

Outcome Measures

Primary Outcomes (1)

• Amount of P. aeruginosa in sputum

  The primary endpoint will be the difference of P. aeruginosa cfu/ml in sputum with combined therapy with Tobramycin/Colistin compared to colistin mono-therapy. The analysis will be adjusted for baseline values of each cycle and parametric (paired t-Test) or non-parametric (sign test) methods will be used as appropriate.

  30 days

Secondary Outcomes (17)

• Course of P.aeruginosa amount in sputum

  112 days

• Course of forced vital capacity (FVC) absolute amount

  112 days

• Course of FVC relative amount

  112 days

• Course of FEV1 absolute amount

  112 days

• Course of FEV1 relative amount

  112 days

Study Arms (2)

Tobramycin powder / Colistin

EXPERIMENTAL

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

Drug: Tobramycin Powder; Drug: Colistin

Colistin

ACTIVE COMPARATOR

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

Drug: Colistin

Interventions

Tobramycin Powder DRUG

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

Also known as: TOBI®Podhaler

Tobramycin powder / Colistin

Colistin DRUG

Colistin solution 2 x daily 1 Mega continuously

Also known as: Colistin solution

Colistin; Tobramycin powder / Colistin

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

MeSH Terms

Interventions

Colistin

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, open label clinical study

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 14, 2017
• Study Start: March 11, 2014
• Primary Completion: December 19, 2015
• Study Completion: November 25, 2016
• Last Updated: November 14, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share