NCT03887338 - Clinical Trial References

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.

Citation(s)

Andersen T, Sandnes A, Brekka AK, Hilland M, Clemm H, Fondenes O, Tysnes OB, Heimdal JH, Halvorsen T, Vollsæter M, Røksund OD
Laryngeal response patterns influence the efficacy of mechanical assisted cough in amyotrophic lateral sclerosis. Thorax. 2017 Mar;72(3):221-229. doi: 10.1136/thoraxjnl-2015-207555. Epub 2016 May 12.
Andersen TM, Halvorsen T, Fondenes O, Heimdal JH, Røksund OD, Vollsæter M, Røksund OD
Larynx: The Complex Gateway to the Lungs. Respir Care. 2019 Jul;64(7):866-869. doi: 10.4187/respcare.06989.
Andersen TM, Sandnes A, Fondenes O, Clemm H, Halvorsen T, Nilsen RM, Tysnes OB, Heimdal JH, Vollsæter M, Røksund OD
Laryngoscopy Can Be a Valuable Tool for Unexpected Therapeutic Response in Noninvasive Respiratory Interventions. Respir Care. 2018 Nov;63(11):1459-1461. doi: 10.4187/respcare.06674.
Andersen TM, Sandnes A, Fondenes O, Nilsen RM, Tysnes OB, Heimdal JH, Clemm HH, Halvorsen T, Vollsæter M, Røksund OD
Laryngeal Responses to Mechanically Assisted Cough in Progressing Amyotrophic Lateral Sclerosis. Respir Care. 2018 May;63(5):538-549. doi: 10.4187/respcare.05924. Epub 2018 Apr 17.
Conde B, Martins N, Brandão M, Pimenta AC, Winck JC
Upper Airway Video Endoscopy: Assessment of the response to positive pressure ventilation and mechanical in-exsufflation. Pulmonology. 2019 Sep - Oct;25(5):299-304. doi: 10.1016/j.pulmoe.2019.02.008. Epub 2019 Apr 16. Review.

Systematic Laryngoscopic Evaluation of Upper Airways in Ventilated Amyotrophic Lateral Sclerosis (ALS) Patients in Portugal and in Norway

Clinical trial NCT03887338 - References