Status Asthmaticus — Treating Exacerbations of Asthma With Oral Montelukast in Children
Citation(s)
Arnold DH, Bowman N, Reiss TF, Hartert TV, Akers WS, Seger DL Adverse events associated with weight-based, high-dose montelukast exposures in children. Clin Toxicol (Phila). 2020 Feb;58(2):145-146. doi: 10.1080/15563650.2019.1609686. Epub 2019 May 6. No
Arnold DH, Bowman N, Reiss TF, Hartert TV, Seger DL Adverse events are rare after single-dose montelukast exposures in children. Clin Toxicol (Phila). 2018 Jan;56(1):25-29. doi: 10.1080/15563650.2017.1337123. Epub 2017 Jun 22.
Arnold DH, Van Driest SL, Reiss TF, King JC, Akers WS Pilot Study of Peak Plasma Concentration After High-Dose Oral Montelukast in Children With Acute Asthma Exacerbations. J Clin Pharmacol. 2021 Mar;61(3):360-367. doi: 10.1002/jcph.1738. Epub 2020 Sep 2
Dose Escalation Clinical Trial of High-dose Oral Montelukast to Inform Future RCT in Children With Acute Asthma Exacerbations
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
