Pulmonary Arterial HypertensionPhase 3INHALE-15NCT00723554
Iloprost Power Disc-15 in Pulmonary Arterial Hypertension
A Phase 3 study testing Iloprost PD-6 and Iloprost PD-15 in people with Pulmonary Arterial Hypertension, run by Actelion at 36 sites in United States.
Trial summary
A Phase IIIb, Multicenter, Open-Label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 to Power Disc-15 With the I-neb® Adaptive Aerosol Delivery® System (I-neb® AAD®) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Iloprost PD-6 and Iloprost PD-15
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 36 sitesUnited States
- Study dates
- Jul 2008to Apr 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to initiation of any study-mandated procedure.
- Male or female patients aged 18-85 years.
- Patients with symptomatic pulmonary arterial hypertension in New York Heart Association (NYHA) functional class III or IV at the time of initiation of iloprost inhalation (Ventavis®) therapy using the Power Disc-6 (PD-6).
- Patients with the following types of pulmonary arterial hypertension (PAH) belonging to World Health Organization (WHO) Group I:
- 1.1: Idiopathic (IPAH)
- 1.2: Familial (FPAH)
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- 1.3: Associated with (APAH)
- 1.3.1: Collagen vascular disease
- 1.3.2: Congenital systemic-to-pulmonary shunts at least 2 years post surgical repair
- 1.3.4: Human immunodeficiency virus (HIV) infection
- 1.3.5: Drugs and toxins
- PAH confirmed by the most recent right heart catheterization showing:
- Mean pulmonary arterial pressure (mPAP)≥ 25 mmHg at rest
- Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg. If both PCWP and LVEDP are available then the LVEDP value is retained for inclusion.
- Pulmonary vascular resistance (PVR) > 240 dyn-sec/cm^5
- Compliant with a treatment regimen of commercial iloprost inhalation (Ventavis® 5 μg) using the I-neb® AAD® equipped with the PD-6 for at least 4 weeks prior to screening.
- Pulmonary function tests (PFTs) including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and total lung capacity (TLC), performed within 6 months of screening.
- If taking other medications for PAH, these must have been stable for 60 days prior to baseline.
- If taking corticosteroids, these must have been stable for 60 days prior to baseline.
- Women of childbearing potential with a negative urine pre-treatment pregnancy test at baseline and who:
- consistently and correctly use (from screening and up to 28 days after discontinuation of study drug) a reliable method of contraception with a Pearl index of < 1%,
- are sexually abstinent, or
- have a vasectomized partner.
- A woman is considered to have childbearing potential unless she meets at least one of the following criteria:
- Previous bilateral salpingo-oophorectomy or hysterectomy
- Premature ovarian failure confirmed by a specialist gynecologist
- XY genotype, Turner syndrome, uterine agenesis
- Is aged > 50 years and not treated with any kind of hormone replacement therapy (HRT) for at least 2 years prior to screening, with amenorrhea for at least 24 consecutive months
Who cannot join
- PAH belonging to WHO group II-V.
- PAH belonging to WHO group I other than that listed in the inclusion criteria, i.e., PAH associated with:
- 1.3.3: Portal hypertension
- 1.3.6: Other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, splenectomy)
- 1.4: Associated with significant venous or capillary involvement:
- 1.4.1: Pulmonary veno-occlusive disease (PVOD)
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- 1.4.2: Pulmonary capillary hemangiomatosis (PCH).
- Receipt of any prostacyclin or prostacyclin analog other than iloprost within 12 weeks before screening.
- Anticipation of the need for intravenous prostacyclin use within 28 days of starting the Power Disc-15 (PD-15).
- HIV-seropositive with any of the following:
- Concomitant active opportunistic infections within 6 months prior to screening
- Detectable viral load within 6 months of screening
- CD4+ T-cell count < 200 mm^3 within 3 months of screening
- Changes in antiretroviral regimen within 3 months of screening
- Anticipated changes in antiretroviral regimen during study periods 1 or 2
- Using inhaled pentamidine
- Systemic hypotension with systolic blood pressure < 95 mmHg.
- Uncontrolled systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement).
- History of left-sided heart disease, including any of the following:
- hemodynamically significant aortic or mitral valve disease
- restrictive or congestive cardiomyopathy
- left ventricular ejection fraction < 40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography
- coronary artery disease with continuing symptoms of angina pectoris
- life-threatening cardiac arrhythmias
- Atrial septostomy within 1 year.
- History of pulmonary embolism prior to diagnosis of PAH unless it can be documented that chronic thromboembolic pulmonary hypertension (CTEPH) has been specifically excluded (e.g., ventilation/perfusion (VQ) scan, pulmonary angiogram).
- Restrictive lung disease: TLC < 60% of normal predicted value.
- Obstructive lung disease: forced expiratory volume/forced vital capacity (FEV1/FVC) < 0.5 or clinically relevant chronic obstructive lung disease or asthma (including any patient requiring concomitant medication to control symptoms of bronchospasm including as needed (p.r.n.) use).
- Clinically relevant bleeding disorder or active bleeding.
- Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C or hepatic cirrhosis.
- Pregnant or breast-feeding.
- Chronic renal insufficiency, as defined by a creatinine of > 2.5 mg/dL or the requirement for dialysis.
- Hemoglobin < 75% of the lower limit of normal range.
- Any condition that prevents compliance with the protocol or adherence to therapy or ability to provide informed consent.
- Participation in any other clinical trial, except observational, or receipt of an investigational product within 30 days prior to enrollment.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21205
Children's Hospital Boston
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
University of Cincinnati
Cincinnati, Ohio, 45267-0564
The Ohio State University Medical Center
Columbus, Ohio, 43210
The Ohio State University, The Dorothy M. Davis Heart & Lung Research Institute
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Henry Ford Health System
Detroit, Michigan, 48202
University of Florida
Gainesville, Florida, 32610
Kaiser Foundation Hospital
Los Angeles, California, 90027
West Los Angeles VA Healthcare Center
Los Angeles, California, 90073
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202
Comprehensive Cardiovascular Care Group LLC
Milwaukee, Wisconsin, 53215
Winthrop University Hospital
Mineola, New York, 11501
University of South Alabama Medical
Mobile, Alabama, 36617
Intermountain Medical Center
Murray, Utah, 84107
North Shore Long Island Jewish Health System
New Hyde Park, New York, 11040
LSU Health Sciences Center
New Orleans, Louisiana, 70112
Beth Israel Medical Center
New York, New York, 10003
Weill Cornell Medical Center
New York, New York, 10021
INTEGRIS Baptist Medical Center, Inc.
Oklahoma City, Oklahoma, 73112
Central Florida Pulmonary Group
Orlando, Florida, 32803
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Arizona Pulmonary Associates, Ltd.
Phoenix, Arizona, 85013
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center-Presbyterian
Pittsburgh, Pennsylvania, 15213
Central Utah Clinic, P.C.
Provo, Utah, 84604
Virginia Commonwealth University Health System
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
Suncoast Lung Research, LLC
Sarasota, Florida, 34233
Saint Louis University
St Louis, Missouri, 63104
SUNY Upstate Medical University
Syracus, New York, 13210
About this study
Official title: A Phase IIIb, Multicenter, Open-label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 (PD-6) to Power Disc-15 (PD-15) With the I-neb® AAD®
A Phase IIIb, Multicenter, Open-Label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 to Power Disc-15 With the I-neb® Adaptive Aerosol Delivery® System (I-neb® AAD®)
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Iloprost PD-6, Iloprost PD-15
- Keywords
- pulmonary arterial hypertension, inhaled therapy, power disc-15
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iloprost PD-6Drug
Also called Ventavis
Period 1 (PD-6): study period defined as the 14 days prior to the first dose of study iloprost inhalation with PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-6 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day
Iloprost PD-15Drug
Also called Ventavis
Period 2 (PD-15): study period between the administration of the first dose with PD-15 on Day 1 until Day 28 inclusive.
Period 3 (PD-15): study period from Day 29 until discontinuation of the PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-15 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day
| Study group | Role | What they receive |
|---|---|---|
| Iloprost | Experimental | The study enrolled patients who were already using iloprost with PD-6 without any safety or tolerability concerns, thereby facilitating a direct comparison of the PD-15 to the PD-6.
The single-arm design allowed each patient to serve as his/her own control Receives: Drug: Iloprost PD-6; Drug: Iloprost PD-15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Reporting Treatment-emergent Adverse Events (AEs)
Number of patients reporting at least one treatment-emergent AE/Serious AE
Measured: From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours
Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE
Number of patients reporting at least one treatment-emergent AE/Serious AE leading to discontinuation of study investigational treatment
Measured: From the first dose of investigational product to study discontinuation, an average of approximately 268 days
Number of Patients Reporting Treatment-emergent Serious AEs
Number of patients reporting at least one treatment-emergent serious AEs
Measured: From the first to last dose of investigational product, an average of approximately 268 days, plus 48 hours
Systolic Blood Pressure - Iloprost PD-6 (Period 1)
Systolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15
Measured: Day 1
Systolic Blood Pressure - Iloprost PD-15 (Period 2)
Systolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15
Measured: Day 28
Systolic Blood Pressure - Iloprost PD-15 (Period 3)
Systolic blood pressure was measured at the end of study visit
Measured: an average of approximately 268 days
Change in Systolic Blood Pressure - (Period 1 to Period 2)
Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)
Measured: Day 1 and Day 28
Change in Systolic Blood Pressure - (Period 1 to Period 3)
Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)
Measured: Day 1 and End of study visit, an average of approximately 268 days
Diastolic Blood Pressure - Iloprost PD-6 (Period 1)
Diastolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15
Measured: Day 1
Diastolic Blood Pressure - Iloprost PD-15 (Period 2)
Diastolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15
Measured: Day 28
Diastolic Blood Pressure - Iloprost PD-15 (Period 3)
Diastolic blood pressure was measured at the end of study visit
Measured: an average of approximately 268 days
Change in Diastolic Blood Pressure - (Period 1 to Period 2)
Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)
Measured: Day 1 and Day 28
Change in Diastolic Blood Pressure - (Period 1 to Period 3)
Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)
Measured: Day 1 and End of study visit, an average of approximately 268 days
Heart Rate - Iloprost PD-6 (Period 1)
Heart rate was measured immediately prior to first dosing with Iloprost PD-15
Measured: Day 1
Heart Rate - Iloprost PD-15 (Period 2)
Heart rate was measured on Day 28 of treatment with Iloprost PD-15
Measured: Day 28
Heart Rate - Iloprost PD-15 (Period 3)
Heart rate was measured at the end of study visit
Measured: an average of approximately 268 days
Change in Heart Rate - (Period 1 to Period 2)
Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)
Measured: Day 1 and Day 28
Change in Heart Rate - (Period 1 to Period 3)
Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)
Measured: Day 1 and End of study visit, an average of approximately 268 days
Secondary outcomes (26)
Average Inhalation Time - Iloprost PD-6 (Period 1)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average of approximately 28 days
Average Inhalation Time - Iloprost PD-15 (Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average of approximately 28 days
Average Inhalation Time - Iloprost PD-15 (Period 3)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average of approximately 240 days
Change in Average Inhalation Time - (Period 1 to Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average approximately 56 days
Average Number of Days of Dosing - Iloprost PD-6 (Period 1)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average of approximately 28 days
Average Number of Days of Dosing - Iloprost PD-15 (Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average of approximately 28 days
Average Number of Days of Dosing - Iloprost PD-15 (Period 3)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average of approximately 240 days
Change in Average Number of Days of Dosing - (Period 1 to Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average approximately 56 days
Average Number of Daily Doses - Iloprost PD-6 (Period 1)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average of approximately 28 days
Average Number of Daily Doses - Iloprost PD-15 (Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average of approximately 28 days
Average Number of Daily Doses - Iloprost PD-15 (Period 3)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average of approximately 240 days
Change in Average Number of Daily Doses - (Period 1 to Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average approximately 56 days
Percentage of Complete Doses Delivered - Iloprost PD-6 (Period 1)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average of approximately 28 days
Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average of approximately 28 days
Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 3)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average of approximately 240 days
Change in Percentage of Complete Doses Delivered - (Period 1 to Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Measured: average approximately 56 days
New York Health Association (NYHA) Functional Class - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)
Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
Measured: average of approximately 28 days
NYHA Functional Class - Iloprost PD-15 (Period 2, Day 28)
Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
Measured: average of approximately 28 days
NYHA Functional Class - Iloprost PD-15 (Period 3, End of Study Visit))
Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
Measured: average of approximately 268 days
Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 2, Day 28)
Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
Measured: average approximately 28 days
Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 3, End of Study Visit)
Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
Measured: average approximately 268 days
Patient Global Self Assessment - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)
The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.
On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the end of study (EOS) visit, patients were asked to compare their PAH status to that of the previous visit.
Measured: average of approximately 28 days
Patient Global Self Assessment - Iloprost PD-15 (Period 2, Day 28)
The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.
On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit.
Measured: average of approximately 28 days
Patient Global Self Assessment - Iloprost PD-15 (Period 3, End of Study Visit))
The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.
On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit.
Measured: average of approximately 268 days
Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 2, Day 28
The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.
On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit.
Measured: average of approximately 28 days
Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 3, End of Study Visit
The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.
On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit.
Measured: average of approximately 268 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2010
- Study completionApr 2011
Why it stopped: sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723554
- Sponsor's protocol ID
- AC-063A402
- Acronym
- INHALE-15
- Status last verified
- Mar 2013
- First submitted
- 24 Jul 2008
- Last updated
- 4 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb, Multicenter, Open-label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 (PD-6) to Power Disc-15 (PD-15) With the I-neb® AAD®
- ClinicalTrials.gov ID
- NCT00723554
- Acronym / sponsor ID
- INHALE-15 / AC-063A402
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- pulmonary arterial hypertension, inhaled therapy, power disc-15
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor's decision
- Enrolment
- 63 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 28 Jul 2008 (estimated)
- Results
- Posted 15 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase IIIb, Multicenter, Open-Label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 to Power Disc-15 With the I-neb® Adaptive Aerosol Delivery® System (I-neb® AAD®)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iloprost | Experimental | Drug: Iloprost PD-6, Drug: Iloprost PD-15The study enrolled patients who were already using iloprost with PD-6 without any safety or tolerability concerns, thereby facilitating a direct comparison of the PD-15 to the PD-6. The single-arm design allowed each patient to serve as his/her own control |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Signed informed consent prior to initiation of any study-mandated procedure.
- Male or female patients aged 18-85 years.
- Patients with symptomatic pulmonary arterial hypertension in New York Heart Association (NYHA) functional class III or IV at the time of initiation of iloprost inhalation (Ventavis®) therapy using the Power Disc-6 (PD-6).
- Patients with the following types of pulmonary arterial hypertension (PAH) belonging to World Health Organization (WHO) Group I:
- PAH confirmed by the most recent right heart catheterization showing:
Key exclusion criteria (35 listed)
- PAH belonging to WHO group II-V.
- PAH belonging to WHO group I other than that listed in the inclusion criteria, i.e., PAH associated with:
- Receipt of any prostacyclin or prostacyclin analog other than iloprost within 12 weeks before screening.
- Anticipation of the need for intravenous prostacyclin use within 28 days of starting the Power Disc-15 (PD-15).
- HIV-seropositive with any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iloprost PD-6Also: VentavisPeriod 1 (PD-6): study period defined as the 14 days prior to the first dose of study iloprost inhalation with PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-6 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day | Drug | Iloprost |
| Iloprost PD-15Also: VentavisPeriod 2 (PD-15): study period between the administration of the first dose with PD-15 on Day 1 until Day 28 inclusive. Period 3 (PD-15): study period from Day 29 until discontinuation of the PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-15 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day | Drug | Iloprost |
Primary outcome
Number of Patients Reporting Treatment-emergent Adverse Events (AEs)
Time frame: From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours
Number of patients reporting at least one treatment-emergent AE/Serious AE
Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE
Time frame: From the first dose of investigational product to study discontinuation, an average of approximately 268 days
Number of patients reporting at least one treatment-emergent AE/Serious AE leading to discontinuation of study investigational treatment
Number of Patients Reporting Treatment-emergent Serious AEs
Time frame: From the first to last dose of investigational product, an average of approximately 268 days, plus 48 hours
Number of patients reporting at least one treatment-emergent serious AEs
Systolic Blood Pressure - Iloprost PD-6 (Period 1)
Time frame: Day 1
Systolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15
Systolic Blood Pressure - Iloprost PD-15 (Period 2)
Time frame: Day 28
Systolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15
Systolic Blood Pressure - Iloprost PD-15 (Period 3)
Time frame: an average of approximately 268 days
Systolic blood pressure was measured at the end of study visit
Change in Systolic Blood Pressure - (Period 1 to Period 2)
Time frame: Day 1 and Day 28
Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)
Change in Systolic Blood Pressure - (Period 1 to Period 3)
Time frame: Day 1 and End of study visit, an average of approximately 268 days
Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)
Diastolic Blood Pressure - Iloprost PD-6 (Period 1)
Time frame: Day 1
Diastolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15
Diastolic Blood Pressure - Iloprost PD-15 (Period 2)
Time frame: Day 28
Diastolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15
Diastolic Blood Pressure - Iloprost PD-15 (Period 3)
Time frame: an average of approximately 268 days
Diastolic blood pressure was measured at the end of study visit
Change in Diastolic Blood Pressure - (Period 1 to Period 2)
Time frame: Day 1 and Day 28
Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)
Change in Diastolic Blood Pressure - (Period 1 to Period 3)
Time frame: Day 1 and End of study visit, an average of approximately 268 days
Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)
Heart Rate - Iloprost PD-6 (Period 1)
Time frame: Day 1
Heart rate was measured immediately prior to first dosing with Iloprost PD-15
Heart Rate - Iloprost PD-15 (Period 2)
Time frame: Day 28
Heart rate was measured on Day 28 of treatment with Iloprost PD-15
Heart Rate - Iloprost PD-15 (Period 3)
Time frame: an average of approximately 268 days
Heart rate was measured at the end of study visit
Change in Heart Rate - (Period 1 to Period 2)
Time frame: Day 1 and Day 28
Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)
Change in Heart Rate - (Period 1 to Period 3)
Time frame: Day 1 and End of study visit, an average of approximately 268 days
Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)
26 secondary outcomes
Average Inhalation Time - Iloprost PD-6 (Period 1)
Time frame: average of approximately 28 days
Average Inhalation Time - Iloprost PD-15 (Period 2)
Time frame: average of approximately 28 days
Average Inhalation Time - Iloprost PD-15 (Period 3)
Time frame: average of approximately 240 days
Change in Average Inhalation Time - (Period 1 to Period 2)
Time frame: average approximately 56 days
Average Number of Days of Dosing - Iloprost PD-6 (Period 1)
Time frame: average of approximately 28 days
Average Number of Days of Dosing - Iloprost PD-15 (Period 2)
Time frame: average of approximately 28 days
Average Number of Days of Dosing - Iloprost PD-15 (Period 3)
Time frame: average of approximately 240 days
Change in Average Number of Days of Dosing - (Period 1 to Period 2)
Time frame: average approximately 56 days
Average Number of Daily Doses - Iloprost PD-6 (Period 1)
Time frame: average of approximately 28 days
Average Number of Daily Doses - Iloprost PD-15 (Period 2)
Time frame: average of approximately 28 days
Average Number of Daily Doses - Iloprost PD-15 (Period 3)
Time frame: average of approximately 240 days
Change in Average Number of Daily Doses - (Period 1 to Period 2)
Time frame: average approximately 56 days
Percentage of Complete Doses Delivered - Iloprost PD-6 (Period 1)
Time frame: average of approximately 28 days
Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 2)
Time frame: average of approximately 28 days
Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 3)
Time frame: average of approximately 240 days
Change in Percentage of Complete Doses Delivered - (Period 1 to Period 2)
Time frame: average approximately 56 days
New York Health Association (NYHA) Functional Class - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)
Time frame: average of approximately 28 days
NYHA Functional Class - Iloprost PD-15 (Period 2, Day 28)
Time frame: average of approximately 28 days
NYHA Functional Class - Iloprost PD-15 (Period 3, End of Study Visit))
Time frame: average of approximately 268 days
Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 2, Day 28)
Time frame: average approximately 28 days
Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 3, End of Study Visit)
Time frame: average approximately 268 days
Patient Global Self Assessment - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)
Time frame: average of approximately 28 days
Patient Global Self Assessment - Iloprost PD-15 (Period 2, Day 28)
Time frame: average of approximately 28 days
Patient Global Self Assessment - Iloprost PD-15 (Period 3, End of Study Visit))
Time frame: average of approximately 268 days
Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 2, Day 28
Time frame: average of approximately 28 days
Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 3, End of Study Visit
Time frame: average of approximately 268 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iloprost PD-6 and Iloprost PD-15 in people with Pulmonary Arterial Hypertension, run by Actelion at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Reporting Treatment-emergent Adverse Events (AEs) (time frame: From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.