Pulmonary Arterial HypertensionPhase 1AIR001-CS02NCT00814645
Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers
A Phase 1 study testing Sodium Nitrite Inhalation Solution in people with Pulmonary Arterial Hypertension, run by Aires Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study is designed to investigate the safety and tolerability of AIR001 Inhalation Solution when administered under conditions of hypoxia and to identify dose levels of drug resulting in a reduction in pulmonary arterial pressure under these hypoxic conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Sodium Nitrite Inhalation Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal male and female volunteers
- Age 18-55
- Demonstrate a rise in pulmonary artery pressure to low inspired oxygen concentration (a normal response to breathing a low level of oxygen)
Who cannot join
- Significant medical illnesses
- Risk factors for pulmonary hypertension
- G6PD or Cytochrome B5 Reductase deficiencies
- History of any form of altitude sickness
- Current prescription or over the counter medication use
Trial locations and contacts
1 site in 1 country.
United States1 site
DaVita Clinical Research
Minneapolis, Minnesota, 55404
About this study
Official title: A Placebo-Controlled, Phase 1b, Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution (AIR001 INHALATION SOLUTION) in Normal, Healthy Volunteers
This study is designed to investigate the safety and tolerability of AIR001 Inhalation Solution when administered under conditions of hypoxia and to identify dose levels of drug resulting in a reduction in pulmonary arterial pressure under these hypoxic conditions.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Sodium Nitrite Inhalation Solution, Placebo and AIR001 Inhalation Solution (Expansion arm)
- 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.
Sodium Nitrite Inhalation SolutionDrug
Also called AIR001 Inhalation Solution
a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
Placebo and AIR001 Inhalation Solution (Expansion arm)Drug
Also called AIR001 Inhalation Solution
On Day 1, subjects will receive a single placebo-form dose of inhaled nebulized AIR001 Inhalation Solution (containing diluent and excipient solutions alone). On Day 2, the same subjects will receive a single administration of AIR001 Inhalation Solution at the minimum pharmacologically active and safe dose identified from dose levels 1-4. Subjects will be blinded to the treatment schema.
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 | Active comparator | a single dose (5 mg sodium nitrite)of AIR001 Inhalation Solution administered by inhalation following nebulization Receives: Drug: Sodium Nitrite Inhalation Solution |
| Dose level 2 | Active comparator | a single dose(15 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization Receives: Drug: Sodium Nitrite Inhalation Solution |
| Dose level 3 | Active comparator | a single dose(45 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization Receives: Drug: Sodium Nitrite Inhalation Solution |
| Dose level 4 | Active comparator | a single dose(113 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization Receives: Drug: Sodium Nitrite Inhalation Solution |
| Expansion arm | Placebo comparator | On Day 1, subjects will receive a single placebo-form dose of inhaled nebulized AIR001 Inhalation Solution (containing diluent and excipient solutions alone). On Day 2, the same subjects will receive a single administration of AIR001 Inhalation Solution at the minimum pharmacologically active and safe dose identified from dose levels 1-4. Subjects will be blinded to the treatment schema. Receives: Drug: Placebo and AIR001 Inhalation Solution (Expansion arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurement of pulmonary arterial pressures by echocardiography.
Measured: Pretreatment and up to 2 hours post treatment
Secondary outcomes (2)
Plasma pharmacokinetics
Measured: Pretreatment to 8 hours post treatment
Hematology, blood chemistry, coagulation and urinalysis, methemoglobin, oxygen saturation, electrocardiogram, troponin, and vital signs and adverse events.
Measured: Pretreatment, post treatment, and 24 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aires Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzanne K Swan, M.D., Principal investigator, Davita Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814645
- Sponsor's protocol ID
- AIR001 CS02
- Acronym
- AIR001-CS02
- Status last verified
- Feb 2012
- First submitted
- 22 Dec 2008
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Phase 1b, Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution (AIR001 INHALATION SOLUTION) in Normal, Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00814645
- Acronym / sponsor ID
- AIR001-CS02 / AIR001 CS02
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Aires Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to investigate the safety and tolerability of AIR001 Inhalation Solution when administered under conditions of hypoxia and to identify dose levels of drug resulting in a reduction in pulmonary arterial pressure under these hypoxic conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 | Active comparator | Drug: Sodium Nitrite Inhalation Solutiona single dose (5 mg sodium nitrite)of AIR001 Inhalation Solution administered by inhalation following nebulization |
| Dose level 2 | Active comparator | Drug: Sodium Nitrite Inhalation Solutiona single dose(15 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization |
| Dose level 3 | Active comparator | Drug: Sodium Nitrite Inhalation Solutiona single dose(45 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization |
| Dose level 4 | Active comparator | Drug: Sodium Nitrite Inhalation Solutiona single dose(113 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization |
| Expansion arm | Placebo comparator | Drug: Placebo and AIR001 Inhalation Solution (Expansion arm)On Day 1, subjects will receive a single placebo-form dose of inhaled nebulized AIR001 Inhalation Solution (containing diluent and excipient solutions alone). On Day 2, the same subjects will receive a single administration of AIR001 Inhalation Solution at the minimum pharmacologically active and safe dose identified from dose levels 1-4. Subjects will be blinded to the treatment schema. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal male and female volunteers
- Age 18-55
- Demonstrate a rise in pulmonary artery pressure to low inspired oxygen concentration (a normal response to breathing a low level of oxygen)
Key exclusion criteria (5 listed)
- Significant medical illnesses
- Risk factors for pulmonary hypertension
- G6PD or Cytochrome B5 Reductase deficiencies
- History of any form of altitude sickness
- Current prescription or over the counter medication use
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 |
|---|---|---|
| Sodium Nitrite Inhalation SolutionAlso: AIR001 Inhalation Solutiona single dose of AIR001 Inhalation Solution administered by inhalation following nebulization | Drug | Dose level 1, Dose level 2, Dose level 3, Dose level 4 |
| Placebo and AIR001 Inhalation Solution (Expansion arm)Also: AIR001 Inhalation SolutionOn Day 1, subjects will receive a single placebo-form dose of inhaled nebulized AIR001 Inhalation Solution (containing diluent and excipient solutions alone). On Day 2, the same subjects will receive a single administration of AIR001 Inhalation Solution at the minimum pharmacologically active and safe dose identified from dose levels 1-4. Subjects will be blinded to the treatment schema. | Drug | Expansion arm |
Primary outcome
The measurement of pulmonary arterial pressures by echocardiography.
Time frame: Pretreatment and up to 2 hours post treatment
2 secondary outcomes
Plasma pharmacokinetics
Time frame: Pretreatment to 8 hours post treatment
Hematology, blood chemistry, coagulation and urinalysis, methemoglobin, oxygen saturation, electrocardiogram, troponin, and vital signs and adverse events.
Time frame: Pretreatment, post treatment, and 24 hours post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
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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.
Suzanne K Swan, M.D. principal investigator
Davita Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sodium Nitrite Inhalation Solution in people with Pulmonary Arterial Hypertension, run by Aires Pharmaceuticals, Inc. at 1 site 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The measurement of pulmonary arterial pressures by echocardiography. (time frame: Pretreatment and up to 2 hours post treatment). 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 17 Feb 2012; AzTrials last refreshed its copy on 6 Nov 2026.