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Mast Cell Stabilizer

RVT-1601 High Dose for Chronic Bronchitis (SCENIC Trial)

Phase 2
Waitlist Available
Research Sponsored by Respivant Sciences GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

Idiopathic pulmonary fibrosis (IPF) is a rare, progressive life-threatening disease that is characterized by exertional dyspnea and persistent dry cough. Cough in IPF is both a presenting and a complicating clinical feature, which affects approximately three quarters of IPF cases. It is often a debilitating symptom that adversely affects quality of life (QoL) and is usually refractory to medical therapy. Inhaled RVT-1601 (formerly, PA101B), a new inhalation formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer, is being evaluated in this Phase 2b study for the treatment of persistent cough in patients with IPF.

Eligible Conditions
  • Chronic Bronchitis
  • Idiopathic Pulmonary Fibrosis Cough
  • Chronic Cough
  • Idiopathic Pulmonary Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 24-hour average cough count
Secondary outcome measures
Change in cough severity
Change in cough-specific QoL
Other outcome measures
Diagnostic Imaging
Change in biomarkers
Change in disease-specific QoL
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: RVT-1601 Mid DoseExperimental Treatment1 Intervention
Group II: RVT-1601 Low DoseExperimental Treatment1 Intervention
Group III: RVT-1601 High DoseExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RVT-1601
2019
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Respivant Sciences Inc.Industry Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
Respivant Sciences GmbHLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
Ahmet Tutuncu, MD, PhDStudy DirectorRespivant Sciences Inc.
3 Previous Clinical Trials
154 Total Patients Enrolled
~17 spots leftby Sep 2025
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