Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)

Browse trials for

• Cystic Fibrosis 1,581
• Fibrosis 3,256

Keywords

• Cystic Fibrosis, Pseudomonas aeruginosa, FEV1, tobramycin inhalation powder, TOBI,
• colistimethate
• Cystic Fibrosis, Pseudomonas aeruginosa, FEV1, tobramycin inhalation powder, TOBI, colistimethate

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 60 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Eligibility criteria

Study arms

• Active comparator
  TIS/TIP

  During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.

  Drug: Tobramycin Inhalation Powder · Drug: Tobramycin inhalation solution

• Active comparator
  COLI/TIP

  During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP, 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.

  Drug: Tobramycin Inhalation Powder · Drug: Colistimethate

• Active comparator
  TIP/TIP

  During the first and second cycles, participants received TIP, 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.

  Drug: Tobramycin Inhalation Powder

Interventions

• DrugTobramycin Inhalation Powder

  Tobramycin Inhalation Powder was administered via TOBI® Podhaler (T-326 inhaler).

  Also known as: TIP

• DrugTobramycin inhalation solution

  Tobramycin inhalation solution was administered via nebuliser

  Also known as: TIS

• DrugColistimethate

  Colistimethate was administered via nebuliser.

  Also known as: COLI

Primary outcomes

1. Mean Total Administration Time

   The mean total time for administration of TIP via T-326 inhaler versus the total time for administration of COLI or TIS was assessed from information entered by participants into an ediary during the last 7 days prior to the last dose of a cycle. The total time included the setup, preparation, administration and cleaning/disinfection time.

   Time frame: days 22 through 28 (cycle 1), days 78 through 84 (cycle 2)

Secondary outcomes

1. Change in P. Aeruginosa Sputum Density

   Sputum samples were sent to a central laboratory at the start and end of 2 treatment periods. The absolute change in the number of colony forming units (CFU) of Pseudomonas aeruginosa in sputum = the value of end of on/off treatment period of the cycle minus the pre-dose value at the start of that cycle. A negative change from baseline indicates improvement.

   Time frame: days 1, 28 (cycle 1); 57, 84, 112 (cycle 2)

2. Number of Participants With Any Contaminated Delivery Device

   Devices used to administer the drugs (the T-326 inhaler and nebulisers) were swabbed for contamination testing at the start and end of each treatment cycle (or discontinuation visit if the participant withdrew). No assessments were required from the T-326 inhaler when participants started the treatment period (days 1 and 57). Microbial contamination was measured according to device type and the frequency of organism growth (light/ moderate/ heavy). All nebulisers (neb) used by the participants were analyzed, including those for inhaling other medications, like mucolytics.

   Time frame: days (d) 1, 28, 57, 84

3. Minimum Inhibitory Concentration (MIC) - MIC50 and MIC90 Tobramycin Values

   MIC50/90 is the lowest concentration required to inhibit 50%/90% of the isolates tested. The MIC50/90 of a range of antibiotics for P.aeruginosa was determined at the start and end of each treatment cycle, and at the end of the off-treatment period of the second cycle.

   Time frame: days 1, 28, 57, 84, 112

4. Number of Participants With Post-inhalation Bronchospasm

   Bronchospasm was defined as the relative decrease of 20% or more in forced expiratory volume in 1 second (FEV1) percent predicted from pre-dose to 15 to 45 minutes post-dose.

   Time frame: days 1, 28, 57, 84

Baseline characteristics

Publications

• Greenwood J, Schwarz C, Sommerwerck U, Nash EF, Tamm M, Cao W, Mastoridis P, Debonnett L, Hamed K. Ease of use of tobramycin inhalation powder compared with nebulized tobramycin and colistimethate sodium: a crossover study in cystic fibrosis patients with pulmonary Pseudomonas aeruginosa infection. Ther Adv Respir Dis. 2017 Jul;11(7):249-260. doi: 10.1177/1753465817710596. PubMed 28614995 ↗