Clinical trial NCT00323024: Dose Determination Safety and Activity Study of Inhaled NX1011 to Treat Pulmonary Arterial Hypertension
Official title: An Open-Label, Dose-Determination Safety, Tolerability, and Activity Study of Inhaled NX1011 in Patients With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Arterial Hypertension
Pulmonary Hypertension
Idiopathic PAH
PH associated with connective tissue disease (CTD)
PH associated with interstitial lung disease (ILD)
PH associated with congestive heart failure (CHF)
PH associated with chronic obstructive pulmonary disease (COPD)
Lead sponsor: NITROX, LLC
Sponsor class: INDUSTRY
First posted: 2006-05-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and maximum tolerated dose of inhaled NX1011 for the treatment of pulmonary arterial hypertension (PAH).


Eligibility criteria: Inclusion Criteria:

* Patient must either:

  * meet the PAH diagnostic criteria at Screening (based on a documented history of diagnosis as outlined in the American College of Chest Physicians \[ACCP\] 2004 Evidence-Based Clinical Practices Guidelines)15; or
  * have elevated pulmonary pressure with a suspected PAH diagnosis based on a clinical referral at Screening for a RHC.
* Patient must have PAH as defined by a mean pulmonary artery pressure (PAP) \> 25 mmHg.
* Patient must have symptoms of pulmonary hypertension (PH) according to the World Health Organization (WHO) Functional Classification of Pulmonary Hypertension Class II through IV.
* Patient must consent to, be able to tolerate, and have adequate venous and arterial access for Swan-Ganz catheterization (SGC) and an arterial line.

Exclusion Criteria:

* Clinically significant right-to-left intracardiac shunts based on Doppler echocardiography with bubble study.
* History of pulmonary veno-occlusive disease or clinically significant aortic or mitral stenosis.
* History of sustained ventricular tachycardia (VT-S) or ventricular fibrillation (VF) and cardiac arrest, or presence of atrial fibrillation.
* Active cardiac disease meeting the following criteria:

  * Patient with elevated pulmonary capillary wedge pressures (PCWPs) \> 25 mmHg.
  * Patient with a history of myocardial infarction or coronary intervention within the last 60 days.
  * Patient with a history of pacemaker, cardiac defibrillator, or biventricular pacemaker insertion within 4 weeks of Baseline.
  * Patient who cannot be withdrawn from nitrate therapy.

Primary outcomes:
measure: To evaluate the safety, tolerability, and activity of inhalation therapy with NX1011 based on right heart catheterization (RHC) measures, pulse oximetry, and hemodynamic response
measure: To establish maximum tolerated dose (MTD) levels of NX1011 based on predefined criteria for dose-limiting toxicity (DLT)
measure: To qualify the delivery apparatus
measure: To generate descriptive data on the concentration-response relationship in order to choose a range of concentrations (e.g., low, medium, high) for the follow-up, fixed-dose, placebo-controlled study
measure: To summarize correlation data between echocardiography and RHC measures with respect to activity and methemoglobin levels documented via the visible light spectroscopy
Secondary outcomes:
measure: To summarize correlation data between echocardiography and RHC measures with respect to activity and methemoglobin levels documented via the visible light spectroscopy
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialists, Ltd.
state: Arizona
city: La Jolla
country: United States
facility: University of California, San Diego Medical Center
state: California
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
Study officials:
affiliation: NITROX, LLC
name: Victoria A Christian
role: STUDY_DIRECTOR
References: