Trial · NCT02633293
An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE
NCT02633293, Phase 2, Phase 3, Terminated, United Therapeutics; results first posted 2022-12-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE. Trials, record NCT02633293. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02633293
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE
- NCT number
- NCT02633293
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 243 participants, actual
- Lead sponsor
- United Therapeutics
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease, Combined Pulmonary Fibrosis and Emphysema
- Interventions
- Inhaled Treprostinil
- First posted
- 2015-12-17
- Last updated
- 2022-12-02
- Results first posted
- 2022-12-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Peak 6-Minute Walk Distance (6MWD) From Baseline | Baseline through Week 124 in RIN-PH-202 (Combined data from parent study RIN-PH-201 [NCT02630316] and this open-label extension study RIN-PH-202) | The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status. Subjects will be instructed to walk down a corridor at a comfortable speed as far as they can manage for 6 minutes. Distance \<500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance \>800 meters (with no rests) suggests mild or no limitation. Peak exposure 6MWD will occur by conducting 6MWT within 10 to 60 minutes after the most recent dose of study drug dose. |
| Secondary | Change in Plasma Concentration of N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline | Baseline through Week 124 in RIN-PH-202 (Combined data from parent study RIN-PH-201 [NCT02630316] and this open-label extension study RIN-PH-202) | The N-terminal pro-BNP (NT-proBNP) serum concentration is a useful biomarker associated with changes in right heart morphology and function. NT-proBNP serum concentration will be assessed to compare the severity of heart failure at Baseline and each visit through Week 124. Blood for NT-proBNP assessment must be drawn prior to conducting the 6-minute walk test (6MWT). |
| Secondary | Change in Percent Predicted Forced Vital Capacity (FVC) From Baseline | Baseline and Weeks 12, 48, and 108 | Change in pulmonary function following inhaled treprostinil therapy will be measured by Forced Vital Capacity (FVC), calculated from a Pulmonary Function Test (PFT) performed at Baseline and Weeks 12, 48, and 108. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Peak 6-Minute Walk Distance (6MWD) From Baseline | Baseline through Week 124 in RIN-PH-202 (Combined data from parent study RIN-PH-201 [NCT02630316] and this open-label extension study RIN-PH-202) | Values are combined data from the Safety Populations of parent study RIN-PH-201 (n=326; NCT02630316) and this open-label extension study RIN-PH-202 (n=243) as presented in the RIN-PH-202 CSR over the course of 124 weeks (16-week treatment in RIN-PH-201 and up to 108 weeks in RIN-PH-202). The number of subjects analyzed at each week decreased as only those remaining on RIN-PH-202 who had not discontinued early due to the reasons show in the Participant Flow section were evaluated. | meters | MEDIAN |
| SECONDARY | Change in Plasma Concentration of N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline | Baseline through Week 124 in RIN-PH-202 (Combined data from parent study RIN-PH-201 [NCT02630316] and this open-label extension study RIN-PH-202) | RIN-PH-202 CSR over the course of 124 weeks (16-week treatment in RIN-PH-201 and up to 108 weeks in RIN-PH-202). The number of subjects analyzed at each week decreased as only those remaining on RIN-PH-202 who had not discontinued early due to the reasons show in the Participant Flow section were evaluated. | pg/mL | MEDIAN |
| SECONDARY | Change in Percent Predicted Forced Vital Capacity (FVC) From Baseline | Baseline and Weeks 12, 48, and 108 | Subjects from the Placebo Group in parent study RIN-PH-201 | Percent Predicted FVC | MEDIAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Peak 6-Minute Walk Distance (6MWD) From Baseline | Inhaled Treprostinil | Week 4 | 1.5 | Full Range -197 to 258 | meters |
| Change in Peak 6-Minute Walk Distance (6MWD) From Baseline | Inhaled Treprostinil | Week 8 | 5.0 | Full Range -259 to 196 | meters |
| Change in Peak 6-Minute Walk Distance (6MWD) From Baseline | Inhaled Treprostinil | Week 12 | 9.5 | Full Range -190 to 192 | meters |
| Change in Peak 6-Minute Walk Distance (6MWD) From Baseline | Inhaled Treprostinil | Week 16 | 10.0 | Full Range -269 to 183 | meters |
| Change in Peak 6-Minute Walk Distance (6MWD) From Baseline | Inhaled Treprostinil | Week 20 | 12.0 | Full Range -189 to 169 | meters |
| Change in Peak 6-Minute Walk Distance (6MWD) From Baseline | Inhaled Treprostinil | Week 28 | 10.0 | Full Range -222 to 175 | meters |
| Change in Peak 6-Minute Walk Distance (6MWD) From Baseline | Inhaled Treprostinil | Week 40 | 3.0 | Full Range -261 to 171 | meters |
| Change in Peak 6-Minute Walk Distance (6MWD) From Baseline | Inhaled Treprostinil | Week 52 | 3.0 | Full Range -223 to 194 | meters |
| Change in Peak 6-Minute Walk Distance (6MWD) From Baseline | Inhaled Treprostinil | Week 64 | -2.0 | Full Range -218 to 178 | meters |
| Change in Peak 6-Minute Walk Distance (6MWD) From Baseline | Inhaled Treprostinil | Week 76 | -2.0 | Full Range -209 to 210 | meters |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Inhaled Treprostinil | 243 | |
| Overall Study | Received Inhaled Treprostinil in RIN-PH-202 (Safety Population) | Inhaled Treprostinil | 242 | |
| Overall Study | COMPLETED | Inhaled Treprostinil | 70 | |
| Overall Study | NOT COMPLETED | Inhaled Treprostinil | 173 |
Source ClinicalTrials.gov
Adverse events184
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cough | Respiratory, thoracic and mediastinal disorders | Inhaled Treprostinil | 65 | 242 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Inhaled Treprostinil | 63 | 242 | |
| other | Headache | Nervous system disorders | Inhaled Treprostinil | 45 | 242 | |
| other | Diarrhoea | Gastrointestinal disorders | Inhaled Treprostinil | 37 | 242 | |
| other | Dizziness | Nervous system disorders | Inhaled Treprostinil | 36 | 242 | |
| other | Upper respiratory tract infection | Infections and infestations | Inhaled Treprostinil | 34 | 242 | |
| other | Nausea | Gastrointestinal disorders | Inhaled Treprostinil | 32 | 242 | |
| other | Fatigue | General disorders | Inhaled Treprostinil | 32 | 242 | |
| other | Pneumonia | Infections and infestations | Inhaled Treprostinil | 30 | 242 | |
| other | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Inhaled Treprostinil | 30 | 242 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inhaled Treprostinil | 56 | 242 |
| Total, other adverse events | Inhaled Treprostinil | 229 | 242 |
| Total, serious adverse events | Inhaled Treprostinil | 133 | 242 |
Source ClinicalTrials.gov
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/NCT02633293
GET https://conductscience.org/api/trials/v1/NCT02633293/results?page=2