Actively Recruiting
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Led by Insmed Incorporated · Updated on 2026-05-04
344
Participants Needed
96
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.
CONDITIONS
Official Title
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of pulmonary hypertension WHO Group 3 associated with interstitial lung disease, including idiopathic interstitial pneumonia, chronic hypersensitivity pneumonitis, connective tissue disease-associated ILD, or combined pulmonary fibrosis and emphysema.
- Fibrotic interstitial lung disease confirmed by CT scan at Screening or within prior 12 months.
- Pulmonary hypertension confirmed by right heart catheterization at Screening or within prior 12 months showing mean pulmonary arterial pressure >20 mmHg, pulmonary capillary wedge pressure 6445 mmHg, and pulmonary vascular resistance 6454 wood units.
- 6-minute walking distance between 100 and 500 meters on two tests at Screening at least 4 hours apart, with less than 15% difference between distances.
- Stable chronic medication for underlying disease and/or PDE5 inhibitors for at least 90 days, with stable dose for 30 days prior to Screening.
- Able to give signed informed consent and comply with study requirements.
You will not qualify if you...
- Diagnosis of pulmonary hypertension WHO Groups 1, 2, 4, or 5, or PH WHO Group 3 subtypes other than interstitial lung disease.
- Primary diagnosis of chronic obstructive pulmonary disease or FEV1/FVC ratio <0.7 based on recent spirometry.
- Clinically significant left heart disease including valvular disease, left ventricular failure with ejection fraction <45%, heart failure with preserved ejection fraction, echocardiography suggestive of postcapillary PH, unstable ischemic heart disease, or unstable arrhythmia except controlled atrial fibrillation.
- Evidence of chronic thromboembolic disease or recent acute pulmonary embolism within 6 months.
- Known allergy or contraindication to treprostinil, TPIP, or formulation excipients such as mannitol or leucine.
- Current smoker of cigarettes or e-cigarettes (smoked at least 100 cigarettes lifetime and currently smoking).
- Current or expected use of inhaled marijuana, recreational or medical, during study or within past 30 days.
- Any other medical or psychological conditions or lab abnormalities that may pose risk, impair study completion, or confound results as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 96 locations
1
USA010
Los Angeles, California, United States, 900275969
Not Yet Recruiting
2
USA001
Santa Barbara, California, United States, 93105-4349
Actively Recruiting
3
USA006
Naples, Florida, United States, 34102-5412
Actively Recruiting
4
USA003
Bend, Oregon, United States, 97701
Actively Recruiting
5
USA013
Philadelphia, Pennsylvania, United States, 19140
Not Yet Recruiting
6
USA008
Richmond, Virginia, United States, 23230
Not Yet Recruiting
7
ARG002
CiudadAutonoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
Not Yet Recruiting
8
ARG003
Río Cuarto, Córdoba Province, Argentina, X5800AEV
Actively Recruiting
9
ARG008
San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
Not Yet Recruiting
10
AUS005
New Lambton Heights, New South Wales, Australia, 2305
Not Yet Recruiting
11
AUS003
Westmead, New South Wales, Australia, 2145
Not Yet Recruiting
12
AUT002
Innsbruck, Austria, 6020
Not Yet Recruiting
13
BEL002
Leuven, Vlaams Brabant, Belgium, 3000
Not Yet Recruiting
14
CZE001
Prague, Czechia, 14000
Actively Recruiting
15
DNK001
Aarhus N, Central Jutland, Denmark, 8200
Not Yet Recruiting
16
FRA009
Nice, Alpes-Maritimes, France, 6001
Not Yet Recruiting
17
FRA002
Marseille, Bouches-du-Rhône, France, 13015
Not Yet Recruiting
18
FRA004
Angers, Maine-et-Loire, France, 49100
Not Yet Recruiting
19
FRA008
Saint Priest En Jarez, Pays de la Loire Region, France, 42270
Not Yet Recruiting
20
FRA003
Le Kremlin-Bicêtre, Val-de-Marne, France, 94270
Actively Recruiting
21
FRA001
Poitiers, Vienne, France, 86000
Not Yet Recruiting
22
FRA010
Brest, France, 29200
Not Yet Recruiting
23
FRA011
Bron, France, 69500
Not Yet Recruiting
24
FRA006
Strasbourg, France, 67091
Not Yet Recruiting
25
GEO002
Tbilisi, Georgia, 0144
Not Yet Recruiting
26
GEO004
Tbilisi, Georgia, 0159
Not Yet Recruiting
27
GEO003
Tbilisi, Georgia, 0180
Actively Recruiting
28
GEO001
Tbilisi, Georgia, 0186
Not Yet Recruiting
29
DEU005
Immenhausen, Baden-Wurttemberg, Germany, 34376
Not Yet Recruiting
30
DEU012
Stuttgart, Baden-Wurttemberg, Germany, 70376
Not Yet Recruiting
31
DEU003
München, Bavaria, Germany, 80335
Not Yet Recruiting
32
DEU006
München, Bavaria, Germany, 80639
Actively Recruiting
33
DEU008
Bonn, North Rhine-Westphalia, Germany, 53127
Not Yet Recruiting
34
DEU009
Homburg, Saarland, Germany, 66424
Not Yet Recruiting
35
DEU010
Gauting, Germany, 82131
Actively Recruiting
36
GRC003
Pátrai, Achaia, Greece, 26504
Not Yet Recruiting
37
ISR003
Petah Tikva, Central District, Israel, 4941492
Not Yet Recruiting
38
ISR002
Jerusalem, Jerusalem, Israel, 9112001
Not Yet Recruiting
39
ISR005
Haifa, Israel, 3109601
Not Yet Recruiting
40
ISR001
Haifa, Israel, 3436212
Not Yet Recruiting
41
ISR004
Tel Aviv, Israel, 6423906
Not Yet Recruiting
42
ITA011
Bologna, Emilia-Romagna, Italy, 40138
Not Yet Recruiting
43
ITA008
Milan, Italy, 20123
Not Yet Recruiting
44
ITA001
Pavia, Italy, 27100
Not Yet Recruiting
45
ITA003
Roma, Italy, 161
Not Yet Recruiting
46
ITA012
Sassari, Italy, 07100
Not Yet Recruiting
47
JPN006
Nagakute, Aichi-ken, Japan, 480-1195
Not Yet Recruiting
48
JPN011
Hirosaki, Aomori, Japan, 036-8563
Not Yet Recruiting
49
JPN002
Narashino-shi, Chiba, Japan, 275-0006
Actively Recruiting
50
JPN004
Narita-shi, Chiba, Japan, 286-8520
Actively Recruiting
51
JPN001
Sapporo, Hokkaido, Japan, 060-8648
Not Yet Recruiting
52
JPN007
Yokohama, Kanagawa, Japan, 236-0051
Actively Recruiting
53
JPN010
Kyotoshi, Kyoto, Japan, 606-8507
Not Yet Recruiting
54
JPN005
Nagano, Nagano, Japan, 380-0928
Not Yet Recruiting
55
JPN015
Sakai, Osaka, Japan, 590-0197
Not Yet Recruiting
56
JPN013
Bunkyo-Ku, Tokyo, Japan, 113-8431
Not Yet Recruiting
57
JPN008
Kiyose, Tokyo, Japan, 204-0023
Not Yet Recruiting
58
JPN003
Shibuya City, Tokyo, Japan, 151-8528
Actively Recruiting
59
JPN016
Tsukuba, Japan, 305-8576
Not Yet Recruiting
60
MYS004
Alor Star, Kedah, Malaysia, 5460
Not Yet Recruiting
61
MYS001
Kota Bharu, Kelantan, Malaysia, 15586
Not Yet Recruiting
62
MYS003
Kuantan, Pahang, Malaysia, 25200
Not Yet Recruiting
63
MYS002
Kuching, Sarawak, Malaysia, 93586
Not Yet Recruiting
64
MYS005
Kajang, Selangor, Malaysia, 43000
Not Yet Recruiting
65
NZL001
Christchurch, Canterbury, New Zealand, 8011
Not Yet Recruiting
66
NZL002
Dunedin, Otago, New Zealand, 9010
Not Yet Recruiting
67
PRT002
Almada, Setúbal District, Portugal, 2805-267
Not Yet Recruiting
68
PRT001
Lisbon, Portugal, 1769-001
Not Yet Recruiting
69
ROU002
Târgu Mureş, Mureș County, Romania, 540136
Not Yet Recruiting
70
ROU001
Timișoara, Timiș County, Romania, 300310
Not Yet Recruiting
71
KOR002
Incheon, South Korea, 21565
Not Yet Recruiting
72
KOR001
Seoul, South Korea, 03080
Actively Recruiting
73
KOR004
Seoul, South Korea, 3722
Not Yet Recruiting
74
KOR006
Seoul, South Korea, 6351
Not Yet Recruiting
75
KOR003
Seoul, South Korea, 6591
Not Yet Recruiting
76
KOR005
Wŏnju, South Korea, 26426
Not Yet Recruiting
77
ESP002
Palma de Mallorca, Balearic Islands, Spain, 7120
Actively Recruiting
78
ESP005
L'Hospitalet de Llobregat, Barcelona, Spain, 8907
Not Yet Recruiting
79
ESP010
Majadahonda, Madrid, Spain, 28222
Not Yet Recruiting
80
ESP012
Barcelona, Spain, 8035
Actively Recruiting
81
ESP004
Barcelona, Spain, 8036
Not Yet Recruiting
82
ESP006
Madrid, Spain, 28041
Actively Recruiting
83
ESP003
Madrid, Spain, 28046
Not Yet Recruiting
84
ESP009
Madrid, Spain, 28304
Not Yet Recruiting
85
ESP011
Santiago de Compostela, Spain, 15706
Not Yet Recruiting
86
ESP001
Seville, Spain, 41009
Not Yet Recruiting
87
ESP007
Toledo, Spain, 45007
Not Yet Recruiting
88
CHE001
Basel, Switzerland, 4031
Not Yet Recruiting
89
CHE002
Zurich, Switzerland, 8091
Not Yet Recruiting
90
TWN003
Hsinchu, Taiwan, 300
Not Yet Recruiting
91
TWN001
Kaohsiung City, Taiwan, 80756
Not Yet Recruiting
92
TWN005
Taichung, Taiwan, 40447
Not Yet Recruiting
93
TWN006
Taipei, Taiwan, 104
Not Yet Recruiting
94
GBR009
London, Greater London, United Kingdom, W12 0HS
Not Yet Recruiting
95
GBR004
Sheffield, Yorkshire, United Kingdom, S10 2JF
Not Yet Recruiting
96
GBR005
Southampton, United Kingdom, SO16 6YD
Not Yet Recruiting
Research Team
I
Insmed Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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