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A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough

Study acronym: FORTITUDE
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Apr 1, 2029 → Sep 1, 2029
See other at-risk trials from McMaster University

Record History

  1. Start date: Apr 1, 2026 to Sep 30, 2026 Primary completion pushed from Apr 1, 2029 to Sep 1, 2029 · Completion pushed from Jul 1, 2029 to Oct 1, 2029 · Secondary endpoints: 9 to 12 · 1 morev2 Show 4 more changesShow less
    • Primary completion pushed from Apr 1, 2029 to Sep 1, 2029
    • Completion pushed from Jul 1, 2029 to Oct 1, 2029
    • Secondary endpoints: 9 to 12
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The FORTITUDE trial will provide head-to-head evidence on the benefits and harms of two commonly prescribed neuromodulators (low-dose morphine and pregabalin), the effectiveness of a virtual cough control therapy, exploratory assessment of potential synergy in combining these interventions, and the long-term outcomes of these treatments in patients with refractory or unexplained chronic cough.
Trial Details
NCT Number NCT07288528
Lead Sponsor McMaster University
Conditions Cough, Refractory Chronic Cough, Unexplained Chronic Cough, Cough Hypersensitivity Syndrome, Chronic Cough
Enrollment 124 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov