scholarly journals Testing the effects of combining azithromycin with inhaled tobramycin for P. aeruginosa in cystic fibrosis: a randomised, controlled clinical trial

Thorax ◽  
2021 ◽  
pp. thoraxjnl-2021-217782
Author(s):  
David P Nichols ◽  
Pradeep K Singh ◽  
Arthur Baines ◽  
Lindsay J Caverly ◽  
James F Chmiel ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Clinical Outcomes ◽  
Forced Expiratory Volume ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Airway Infection ◽  
Patient Reported ◽  
Trial Testing ◽  
Randomised Controlled ◽  
Oral Azithromycin

RationaleInhaled tobramycin and oral azithromycin are common chronic therapies in people with cystic fibrosis and Pseudomonas aeruginosa airway infection. Some studies have shown that azithromycin can reduce the ability of tobramycin to kill P. aeruginosa. This trial was done to test the effects of combining azithromycin with inhaled tobramycin on clinical and microbiological outcomes in people already using inhaled tobramycin. We theorised that those randomised to placebo (no azithromycin) would have greater improvement in forced expiratory volume in one second (FEV1) and greater reduction in P. aeruginosa sputum in response to tobramycin.MethodsA 6-week prospective, randomised, placebo-controlled, double-blind trial testing oral azithromycin versus placebo combined with clinically prescribed inhaled tobramycin in individuals with cystic fibrosis and P. aeruginosa airway infection.ResultsOver a 6-week period, including 4 weeks of inhaled tobramycin, the relative change in FEV1 did not statistically significantly differ between groups (azithromycin (n=56) minus placebo (n=52) difference: 3.44%; 95% CI: −0.48 to 7.35; p=0.085). Differences in secondary clinical outcomes, including patient-reported symptom scores, weight and need for additional antibiotics, did not significantly differ. Among the 29 azithromycin and 35 placebo participants providing paired sputum samples, the 6-week change in P. aeruginosa density differed in favour of the placebo group (difference: 0.75 log10 CFU/mL; 95% CI: 0.03 to 1.47; p=0.043).ConclusionsDespite having greater reduction in P. aeruginosa density in participants able to provide sputum samples, participants randomised to placebo with inhaled tobramycin did not experience significantly greater improvements in lung function or other clinical outcomes compared with those randomised to azithromycin with tobramycin.

scholarly journals TREAT Early Arthralgia to Reverse or Limit Impending Exacerbation to Rheumatoid arthritis (TREAT EARLIER): a randomized, double-blind, placebo-controlled clinical trial protocol

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Ellis Niemantsverdriet ◽  
Yousra J. Dakkak ◽  
Leonie E. Burgers ◽  
Femke Bonte-Mineur ◽  
Gerda M. Steup-Beekman ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Primary Endpoint ◽  
Logical Consequence ◽  
Controlled Clinical Trial ◽  
Care Hospital ◽  
Subclinical Inflammation ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Patient Reported ◽  
Clinical Arthritis

Abstract Background We present a study protocol for a randomized, double-blind, placebo-controlled trial that investigates the hypothesis if intervention in the symptomatic phase preceding clinical arthritis (clinically suspect arthralgia (CSA)) is effective in preventing progression from subclinical inflammation to clinically apparent persistent arthritis. Currently, rheumatoid arthritis (RA) can be recognized and diagnosed when arthritis (joint swelling) has become detectable at physical examination. Importantly, at this time, the immune processes have already matured, chronicity is established, and patients require long-standing treatment with disease-modifying anti-rheumatic drugs. The TREAT EARLIER trial studies the hypothesis that intervention in the symptomatic phase preceding clinical arthritis is more often successful in permanent disease modification because of less matured underlying disease processes. Methods A two-level definition to identify patients that are prone to develop RA is used. First, patients should have CSA and recent-onset arthralgia (< 1 year) that is suspect to progress to RA according to the expertise of the treating rheumatologist. Second, patients need to have subclinical inflammation of the hand or foot joints at 1.5 T MRI. The trial aims to recruit 230 participants from secondary care hospital settings across the south-west region of The Netherlands. Intervention will be randomly assigned and includes a single-dose of intramuscular 120 mg methylprednisolon followed by methotrexate (increasing dose to 25 mg/week orally) or placebo (both; injection and tablets) over the course of 1 year. Thereafter, participants are followed for another year. The primary endpoint is the development of clinically detectable arthritis, either fulfilling the 2010 criteria for RA or unclassified clinical arthritis of ≥ 2 joints, which persists for at least 2 weeks. DMARD-free status is a co-primary endpoint. The patient-reported outcomes functioning, along with workability and symptoms, are key secondary endpoints. Participants, caregivers (including those assessing the endpoints), and scientific staff are all blinded to the group assignment. Discussion This proof-of-concept study is the logical consequence of pre-work on the identification of patients with CSA with MRI-detected subclinical joint inflammation. It will test the hypothesis whether intervention in patients in this early phase with the cornerstone treatment of classified RA (methotrexate) hampers the development of persistent RA and reduce the disease burden of RA. Trial registration Dutch Trial Register NL4599 (NTR4853). Registered on 20 October 2014

Pre-emptive triple analgesia protocol for tonsillectomy pain control in children: double-blind, randomised, controlled, clinical trial

2013 ◽  
Vol 127 (4) ◽  
pp. 383-391 ◽  
Author(s):  
A M A El-Fattah ◽  
E Ramzy
Keyword(s):  
Postoperative Pain ◽  
Visual Analogue Scale ◽  
Analogue Scale ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Post Surgery ◽  
Scale Scores ◽  
Randomised Controlled ◽  
At Home

AbstractIntroduction:This double-blind, controlled, parallel-group study was designed to determine the efficacy of pre-emptive triple analgesia for paediatric post-tonsillectomy pain management.Materials and methods:One hundred and thirty-five children were randomised into two groups: pre-emptive triple analgesia (n = 55) and control (n = 80). Pain was assessed using a visual analogue scale (in hospital) and the Parent's Postoperative Pain Measure (at home), and scores recorded.Results:Visual analogue scale scores on awakening and for 6 hours post-surgery were significantly better in the study group than the control group (p < 0.05). The Parent's Postoperative Pain Measure scores of control group children were significantly higher within the first 3 post-operative days (p = 0.000), with a greater percentage of children experiencing significant pain and requiring more analgesia.Conclusion:The proposed multimodal, pre-emptive analgesia protocol for paediatric post-tonsillectomy pain results in less post-operative pain, both in hospital or at home.

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