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primary studies published RCT

Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginosa colonization: results of a randomized, double-blind, placebo-controlled pilot study.

  • Year: 2014
  • Date: 2014
  • Author: Mainz JG
Source

Drug Des Devel Ther. 2014 Feb 10;8:209-17. doi: 10.2147/DDDT.S54064. eCollection 2014.

Study design (if review, criteria of inclusion for studies)

randomized controlled trial

Participants

Nine CF patients

Interventions

Patients were randomized to inhalation of tobramycin (80 mg/2 mL) or placebo (2 mL isotonic saline) once daily (4 minutes/nostril) with the PARI Sinus nebulizer over 28 days, with all patients eligible for a subsequent course of open-label inhalation of tobramycin for 28 days.

Outcome measures

Nasal lavage was obtained before starting and 2 days after the end of each treatment period by rinsing each nostril with 10 mL of isotonic saline. P. aeruginosa quantity. SNOT-20 score

Main results

Nine patients participated, six initially receiving tobramycin and three placebo. Sinonasal inhalation was well tolerated, with serum tobramycin <0.5 mg/L and stable creatinine. P. aeruginosa quantity decreased in four of six (67%) patients given tobramycin, compared with zero of three given placebo (non-significant). SNOT-20 scores were significantly lower in the tobramycin than in the placebo group (P=0.033).

Authors' conclusions

Sinonasal inhalation of vibrating antibiotic aerosols appears promising for reducing pathogen colonization of paranasal sinuses and for control of symptoms in patients with CF.

Related topics

Antibiotic treatment of early pseudomonas aeruginosa

Antibiotics for pulmonary exacerbations

Inhaled antibiotics in cystic fibrosis

MRSA eradication in CF

Prophylactic use of oral antistaphylococcal antibiotic

Scheduled antibiotics every 3-4 months / symptom-based treatment

Keywords: Anti-Bacterial Agents; Pseudomonas aeruginosa; Pseudomonas; Tobramycin; Bacterial Infections; Infection; Inhalation OR nebulised; nebuliser; non pharmacological intervention - devices OR physiotherapy; pharmacological_intervention; Respiratory Tract Diseases; Respiratory Tract Infections; Airway clearance technique; Vibration; Aminoglycosides;