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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01725269




Registration number
NCT01725269
Ethics application status
Date submitted
8/11/2012
Date registered
12/11/2012
Date last updated
9/04/2014

Titles & IDs
Public title
Long-term Study of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension Who Completed AIR001-CS05
Scientific title
A Phase 2, Multicenter, Open-Label Study to Evaluate the Intermediate/Long Term Safety and Efficacy of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension
Secondary ID [1] 0 0
AIR001-CS06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AIR001

Experimental: 80mg AIR001, nebulized four times daily - AIR001, 80 mg into nebulizer

Experimental: 46 mg AIR001, nebulized four times daily - AIR001, 46 mg into nebulizer

Experimental: 80mg AIR001, nebulized once daily - AIR001, 80 mg into nebulizer


Treatment: Drugs: AIR001
All doses specified are the amount loaded into the I-neb AAD System nebulizer.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the intermediate/long-term safety of inhaled nebulized AIR001
Timepoint [1] 0 0
minimum of 6 months
Secondary outcome [1] 0 0
To assess the effect of inhaled AIR001 on Time to Clinical Worsening, 6MWD, Functional Class, and Quality of Life
Timepoint [1] 0 0
minimum of 6 months

Eligibility
Key inclusion criteria
1. Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the study prior to initiation of any subject-mandated procedures.

2. Is willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study procedures.

3. Has completed the 16-week AIR001-CS05study as planned.

4. If on corticosteroids, has been receiving a stable dose of less than or equal to 20
mg/day of prednisone (or equivalent dose, if other corticosteroid) for at least 1
month (30 days) prior to the AIR001-CS05 study Baseline/Day 1 visit. If receiving
treatment for Connective Tissue Disease (CTD) with any other drugs, doses should
remain stable, if clinically feasible, for the duration of the AIR001-CS06 study.

5. Women of childbearing potential must be using at least one form of medically
acceptable contraception (i.e. either oral, topical, implanted hormonal
contraceptives, or an intrauterine device) or two barrier methods; have a negative
pregnancy test at Screening and Baseline/Day 1 and agree to use reliable methods of
contraception until at least 24-hours after the last dose of study drug. Women who are
surgically sterile (i.e. hysterectomy, bilateral oophorectomy, or tubal ligation) or
those who are post-menopausal for at least 2 years are not considered to be of
childbearing potential. Men who are not sterile (i.e. have not had a vasectomy) must
also agree to use contraception until at least 24-hours after the last dose of study
drug.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participation in a device or other interventional clinical studies (other than
AIR001-CS05), within 1 month (30 days) of Baseline/Day 1 and/or during study
participation.

2. Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure
> 160 mmHg or sitting diastolic blood pressure > 100 mmHg during Baseline/Day 1 visit.

3. Systolic blood pressure < 90 mmHg at Baseline/Day 1.

4. Diagnosis of Down syndrome.

5. Moderate to severe hepatic impairment classified as a Child-Pugh Class B or C at
Baseline/Day 1.

6. Has chronic renal insufficiency as defined by serum creatinine > 2.5 mg/dL or has an
estimated Glomerular Filtration Rate (eGFR) < 30 mL/min at Baseline/Day 1, or requires
dialytic support.

7. Has a hemoglobin (Hgb) concentration < 8.5 g/dL at Baseline/Day 1.

8. Personal or family history of the following:

1. Congenital or acquired methemoglobinemia;

2. RBC CYPB5 reductase deficiency.

9. History of glucose-6-phosphate dehydrogenase (G6PD) deficiency or any contraindication
to receiving methylene blue.

10. For subjects with Human immunodeficiency virus (HIV) associated PAH, requirement for
the use of inhaled pentamidine.

11. The use of oral or topical nitrates (nitroglycerin, glyceryl trinitrate (GTN),
isosorbide dinitrate, and isosorbide mononitrate) within 1 month (30 days) prior to
Baseline/Day 1 or throughout the AIR001-CS06 study until EOS or Termination visit.
Note: Intravenous GTN in an emergency setting may be administered by starting with a
low dose and titrating upward, while the subject is being monitored closely for
changes in blood pressure and heart rate.

12. Known or suspected hypersensitivity or allergic reaction to sodium nitrite or sodium
nitrate.

13. History of malignancy within 5-years prior to Baseline/Day 1 of the AIR001-CS05 study,
with the exception of localized non-metastatic basal cell carcinoma of the skin and in
situ carcinoma of the cervix.

14. Other severe acute or chronic medical or laboratory abnormality that may increase the
risk associated with study participation or investigational product administration or
may interfere with the interpretation of study results and, in the judgment of the
investigator, would make the subject inappropriate for entry into this study.

15. Has a psychiatric, addictive or other disorder that compromises the ability to give
informed consent for participating in this study. This includes subjects with a recent
history of abusing alcohol or illicit drugs 1 month (30 days) prior to study
Baseline/Day 1 of the AIR001-CS05 study and for the duration of the study.

16. Is currently pregnant or breastfeeding or intends to become pregnant during the
duration of the study.

17. Investigators, study staff or their immediate families.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2014
Sample size
Target
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Hungary
State/province [13] 0 0
Budapest
Country [14] 0 0
Hungary
State/province [14] 0 0
Debrecen
Country [15] 0 0
Hungary
State/province [15] 0 0
Szeged

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Aires Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The AIR001-CS05 study evaluated the safety and efficacy (effectiveness) of AIR001 over 16
weeks in subjects who have PAH. The purpose of the AIR001-CS06 study is to evaluate the
intermediate / long-term safety of AIR001 in subjects who have completed the AIR001-CS05
study. Assessments to evaluate the effectiveness of the study drug will include measurements
of exercise ability and evaluations of PAH disease symptoms.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01725269
Trial related presentations / publications
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Public notes

Contacts
Principal investigator
Name 0 0
Adaani E Frost, M.D.
Address 0 0
Baylor College of Medicine, Houston
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01725269