Trial · NCT03864328
A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
NCT03864328, Phase 2, Terminated, Respivant Sciences GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF. Trials, record NCT03864328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03864328
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
- NCT number
- NCT03864328
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 108 participants, actual
- Lead sponsor
- Respivant Sciences GmbH
- Conditions
- Persistent Cough in IPF, Chronic Cough, IPF
- Interventions
- RVT-1601, Placebo
- First posted
- 2019-03-06
- Last updated
- 2020-06-11
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in 24-hour average cough count | 12 weeks | Objective cough count monitoring performed using a digital recording device. |
| Secondary | Change in cough severity | 12 weeks | Cough severity assessed using Visual Analog Scale (VAS), a single-item questionnaire using 100-point scale ranging from 0 (no cough) to 100 (extremely severe cough). |
| Secondary | Change in cough-specific QoL | 12 weeks | Cough-specific QoL assessed using Leicester Cough Questionnaire (LCQ), a 19-item questionnaire designed to measure impact of cough in three domains (physical, psychological and social), each domain ranging from 1 to 7 and LCQ total score ranging from 3 to 21, with the higher scores corresponding with better QoL. |
| Other | Change in forced vital capacity (FVC) | 12 weeks | FVC measured as the total amount of air exhaled during pulmonary function test. |
| Other | Change in disease-specific QoL | 12 weeks | Disease-specific QoL assessed using King's Brief Interstitial Lung Disease Questionnaire (K-BILD), a 15-item questionnaire designed to measure impact of interstitial lung disease in three domains (breathlessness and activities, psychological and chest symptoms), each domain and total score ranging from 0 to 100 with the higher scores corresponding with better QoL. |
| Other | Change in airway and lung volumes as measured by HRCT images | 12 weeks | HRCT-based functional respiratory imaging (FRI) parameters measured at end-inspiration and end-expiration. |
| Other | Change in biomarkers | 12 weeks | Collagen degradation by-products measured in the blood. |
| Other | Change in respiratory-related QoL | 12 weeks | Respiratory-related QoL assessed using St. George's Respiratory Questionnaire (SGRQ), a 50-item questionnaire designed to measure impact of respiratory symptoms on overall health, daily life, and perceived well-being, with total score ranging from 0 to 100 and lower score denoting a better health status. |
| Other | Change in dyspnea score | 12 weeks | Dyspnea score assessed using University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ),a 24-item questionnaire designed to measure breathlessness on a scale from 0 (not at all breathless) to 5 (maximally breathless or too breathless to do the activity). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03864328
GET https://conductscience.org/api/trials/v1/NCT03864328/registered