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Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease

Study acronym: RESPIRE-ILD
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 3 to 4v8
  2. Study sites: 2 to 3v7
  3. Site details revised at 1 of 2 sitesv6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2024 to Jan 7, 2025
    • Site details revised at 2 of 2 sites
    v5
  5. Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's to David Palma
    • Start date: May 1, 2024 to Aug 1, 2024
    • Eligibility criteria expanded, about 84 words
    v4
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  1. Start date: Dec 1, 2023 to May 1, 2024v3
  2. Interventions: Dexamethasone Oral (Drug), Dexamethasone Placebo (Drug), N-Acetyl cysteine (Dietary Supplement), N-Acetyl cysteine Placebo (Dietary… to Dexamethasone Oral (Drug), Dexamethasone Placebo (Drug), N-Acetyl cysteine (Dietary Supplement), N-Acetyl cysteine Placebo (Dietary…
    • Secondary endpoints: details revised at 5 of 11 entries
    • Study description revised
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
David Palma
6 trials monitored
See 1 trial at risk
Lung Cancer
4,790 trials monitored
See 263 trials at risk
In this double-blind phase II randomized controlled trial, patients with lung cancer or ≤2 oligometastatic pulmonary lesions and a concomitant diagnosis of ILD who are planned for radical Radiation Therapy (RT) will be randomized using a 2 x 2 factorial design to oral N-acetylcysteine (NAC) versus placebo, and also to short course corticosteroids versus placebo.
Trial Details
NCT Number NCT05986318
Lead Sponsor David Palma
Collaborators: London Health Sciences Centre, Centre hospitalier de l'Université de Montréal (CHUM)
Conditions
(from sponsor)		 Lung Cancer, Interstitial Lung Disease
Related terms Lung Diseases, Interstitial, Lung Neoplasms, Radiation Pneumonitis
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov