{"id":2985,"date":"2017-01-05T04:41:23","date_gmt":"2017-01-05T09:41:23","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=2985"},"modified":"2025-09-20T19:15:58","modified_gmt":"2025-09-21T01:15:58","slug":"aerosolized-antibiotics-part-3-avoid-hitting-wall","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2017\/01\/05\/2985\/aerosolized-antibiotics-part-3-avoid-hitting-wall\/","title":{"rendered":"Aerosolized Antibiotics (Part 3) \u2013 How To Avoid Hitting A Wall"},"content":{"rendered":"

\"\"<\/a><\/p>\n

As the 2017 Holiday Season\u00a0[1]<\/a> is upon us, here some concepts to ponder while in the mood. Certainly not strategic imperatives, just musings and thoughts for discussion:<\/p>\n

#1: Consider developing your inhaled antibiotic in CF first. Pursuing a new indication is high risk, akin to playing Russian roulette but with a revolver that has 5 rounds and only 1 blank.\u00a0 You might get lucky but the odds are \u2013 hmm – \u00a0against you.<\/p>\n

#2: For therapeutic efficacy trials, do not commit to a superiority design unless you absolutely have to. There are a few exceptions to this rule but in most situations you stand\u00a0to lose your shirt in the attempt.<\/p>\n

#3: Stay away from therapeutic interventions, go instead first for prophylaxis . Again, we can think of a few exceptions to this rule, but therapeutic efficacy in non-CF indications is not something you want to establish unless you have a big NIH grant or don\u2019t care about LoS.<\/p>\n

#4: Don\u2019t believe your aerosol is better than the concomitant systemic therapy – because it is not.<\/p>\n

#5: Eliminate any and all kinds of background noise that could drown out a (probably weak) efficacy signal \u2013 and give your aerosol a chance to show the blip of efficacy enhancement you are trying to catch.<\/p>\n

#6: Select your efficacy and infection markers carefully. When dealing with add-on therapy it is advisable to hone in on symptomatic\u00a0patients with high bacterial load. Very high load is even better.<\/p>\n

#7:\u00a0 Don\u2019t study VAT: There is no price for improving colonization either qualitatively or quantitatively.<\/p>\n

Footnotes:
\n<\/strong>[1]<\/a> Sorry this blog did not make it in time for the 2016<\/span> Holiday Season \u2013 The Editors<\/p>\n

Abbreviations:<\/strong>
\nLoS \u00a0 Likelihood of success
\nVAT \u00a0 ventilator-associated tracheitis
\nCF \u00a0 \u00a0cystic fibrosis<\/p>\n","protected":false},"excerpt":{"rendered":"

As the 2017 Holiday Season\u00a0[1] is upon us, here some concepts to ponder while in the mood. Certainly not strategic imperatives, just musings and thoughts for discussion: #1: Consider developing your inhaled antibiotic in CF first. Pursuing a new indication is high risk, akin to playing Russian roulette but with Continue reading Aerosolized Antibiotics (Part 3) \u2013 How To Avoid Hitting A Wall<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":2988,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[18],"tags":[1866,1271,403,891,1583,1847,153,1867,1705],"class_list":["post-2985","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the_viewpoint","tag-aerosolized-antibiotics","tag-allphase-pharma-consulting","tag-antibiotic-blog","tag-cystic-fibrosis","tag-harald-reinhart","tag-nebulized-antibiotics","tag-non-inferiority","tag-strategic-trial-design","tag-study-design"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2017\/01\/Inhalational-Abx-sliderPart3.jpg?fit=640%2C180&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-M9","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":1314,"url":"https:\/\/allphasepharma.com\/dir\/2015\/03\/25\/1314\/aerosolized-antibiotics-selling-nebulizers\/","url_meta":{"origin":2985,"position":0},"title":"Aerosolized Antibiotics & Selling Nebulizers","author":"Harald","date":"March 25, 2015","format":false,"excerpt":"\u201cThe medicine comes for free, just pay us for the inhaler\u201d should be the marketing slogan for this group of therapeutics.\u00a0 Nebulizers are good business: hard to copy as a delivery system, they are a great opportunity to \u2018evergreen\u2019 off-patent antibiotics. The inhalational route to administer antibiotics is clearly attractive.\u00a0\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":2955,"url":"https:\/\/allphasepharma.com\/dir\/2016\/12\/22\/2955\/aerosolized-antibiotics-part-2-disappointing-news-fronts\/","url_meta":{"origin":2985,"position":1},"title":"Aerosolized Antibiotics (Part 2) \u2013 Mixed News on Two Fronts","author":"Harald","date":"December 22, 2016","format":false,"excerpt":"INSMED - NTM The company that is developing Arikayce, a preparation of liposomal amikacin inhalation (LAI), for the treatment of NTM had to withdraw its MAA in Europe earlier this year\u00a0[1] because data was not convincing enough for regulators to approve the application. Insmed now has to wait until more\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/12\/Inhalational-Abx-sliderPart2.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/12\/Inhalational-Abx-sliderPart2.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/12\/Inhalational-Abx-sliderPart2.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":2942,"url":"https:\/\/allphasepharma.com\/dir\/2016\/12\/15\/2942\/antibiotic-inhalers-galore-part-1-more-combinations-permutations-rubiks-cube\/","url_meta":{"origin":2985,"position":2},"title":"Antibiotic Inhalers Galore (Part 1): \u00a0More Combinations and Permutations than a Rubik\u2019s Cube","author":"Harald","date":"December 15, 2016","format":false,"excerpt":"There is much interest in inhaled antibiotics these days.\u00a0 Prima facie, the logic for this approach is compelling: Getting the antibiotic (and a lot of it) directly to the site of infection, while avoiding systemic toxicity, sounds like optimized efficacy plus optimized safety combined.\u00a0 However, some high-profile failures were published\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/12\/Inhalational-Abx-slider.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/12\/Inhalational-Abx-slider.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/12\/Inhalational-Abx-slider.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":2993,"url":"https:\/\/allphasepharma.com\/dir\/2017\/01\/09\/2993\/aradigm-lost-orbit-hayward-problem\/","url_meta":{"origin":2985,"position":3},"title":"Aradigm Lost in ORBIT \u2013 Hayward, We Have a Problem","author":"Harald","date":"January 9, 2017","format":false,"excerpt":"It is interesting to see how often a discussion of study results moves from microbiology to clinical significance to statistical analysis details. 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