Cross-Over Study of Subcutaneous Study Drug for the Treatment of Patients With Mild to Moderate Asthma

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Palatin Technologies
Sponsor:
Information provided by (Responsible Party):
Palatin Technologies
ClinicalTrials.gov Identifier:
NCT01304628
First received: February 22, 2011
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

The objective of this study is to evaluate if single subcutaneous (SC) doses of PL-3994, administered to patients with asthma can achieve a clinically meaningful increase in pulmonary function (Forced Expiratory Volume in one second: FEV1) while maintaining an acceptable safety profile. The study will characterize the bronchodilator effect, dose and safety of PL-3994 in a population of moderately severe, stable asthmatics following overnight withdrawal of beta-2 agonists.


Condition Intervention Phase
Asthma
Drug: PL-3994
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a, Double-Blinded, Multi-Center, Escalating Dose Group, Placebo Controlled, Cross-Over Study to Evaluate the Safety, Efficacy and Tolerability of Subcutaneously Administered PL-3994 for the Treatment of Patients With Mild to Moderate Asthma

Resource links provided by NLM:


Further study details as provided by Palatin Technologies:

Primary Outcome Measures:
  • Change in Forced Expiratory Volume in one second (FEV1) [ Time Frame: Throughout 12 hours post dosing ] [ Designated as safety issue: No ]
    Serial spirometry measures, including FEV1, assessed at specified time periods over 12 hours post dose.


Secondary Outcome Measures:
  • Change in Forced Vital Capacity (FVC) [ Time Frame: Throughout 12 hours post dosing ] [ Designated as safety issue: No ]
    Serial spirometry measures, including FVC, assessed at specified time periods over 12 hours post dose.


Estimated Enrollment: 56
Study Start Date: June 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PL-3994 (4 escalating doses) Drug: PL-3994
subcutaneous PL-3994, single dose, 4 escalating dose groups
Placebo Comparator: Placebo Drug: PL-3994
subcutaneous PL-3994, single dose, 4 escalating dose groups

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has provided written informed consent
  • The subject is male or female >18 to 65 years of age
  • Patient has a clinical history of asthma as defined by the National Asthma Education and Prevention Program.
  • Documented bronchodilator response to albuterol as defined by the American Thoracic Society (> 200 mL and > 12% increase in FEV1 after bronchodilator inhalation)
  • FEV1 post-bronchodilator of between 55% and 80% predicted.
  • Currently taking 200-1000 mcg (fluticasone equivalent) of inhaled corticosteroids
  • All inclusion criteria met within the past 12 months.
  • If the subject or subject's partner is of child-bearing potential, a medically acceptable form of contraception will be used for three months prior to the screening visit (females only), for the duration of the study and for one month following the last dose of the study drug. Medically acceptable contraceptives include: (1) surgical sterilization, (2) FDA-approved female hormonal contraceptives, (3) an intrauterine device (IUD), (4) condoms with spermicide, or (5) diaphragm with spermicide.

If the subject had a vasectomy greater than 6 months prior to the screen visit, this will also be acceptable.

Exclusion Criteria:

  • Current diagnosis, as per subject or investigator or screening assessment, of:

    • unstable or uncontrolled disease in any organ system (including cardiovascular) on present therapy
    • psychiatric disease requiring daily medication, including controlled or uncontrolled schizophrenia or any other uncontrolled psychiatric condition
    • significant neurological disease
    • current or history of any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to screening
    • acute or chronic disease requiring frequent changes in medications or changes in dosages of chronic therapy
    • history of alcohol abuse within the past 5 years
    • positive result for the alcohol and/or drug tests at screening or check-in
    • positive for HIV, or Hep B&C at screening
    • blood donation within 30 days of screening or plasma donation within 7 days of screening
    • weight > 100 kg or < 50 kg
    • clinically significant electrocardiogram (ECG) at screening
    • any clinically significant (per the investigator) lab abnormalities
    • any fever or other clinically significant physical exam abnormalities
  • History of COPD or any other lung disease
  • Greater than 10 packs per year smoking history and any cigarette smoking within the past 12 months
  • Patients unable to withhold bronchodilator treatment for 12 hours prior to dosing
  • Patients with hypoxia at screen or Check -in Visit 2, Day 1 or Visit 3, Day 7 (oxygen saturation measured by pulse oximetry [SpO2] < 90%)
  • Tachycardia (heart rate > 100 beats/min) at screening
  • Currently being treated for Hypertension or taking any other medications that affect blood pressure significantly.
  • Currently taking any medications that inhibit PDE activity or which affect the cyclic guanisine mono-phosphate (cGMP) pathway (e.g. theophylline). These medications will be prohibited during the study and for at least 5 half- lives prior to Check-in Visit 2, Day 1 or Visit 3, Day 7 so that cGMP measurements will not be affected.
  • Hypotension (systolic blood pressure < 110 mmHg) at Screening or Check-in Visit 2, Day 1 or Visit 3, Day 7
  • Chronic kidney disease defined as estimated glomerular filtration rate (eGFR) <50 mL/m2.
  • Diagnosis of heart failure or history of hospitalization for congestive heart failure.
  • History of coronary artery disease defined as prior myocardial infarction, prior revascularization procedure, or >50% coronary artery obstruction by angiography.
  • Prior history of stroke or transient ischemic attack.
  • Female patients of childbearing potential who are nursing or have a positive pregnancy test at Screening or Check -in Visit 2, Day 1 or Visit 3, Day 7
  • Any major disability or disease with expected survival less than 6 months
  • Administration of any investigational drug or implantation of investigational device, or participation in another trial, within 30 days of screening.
  • Inability to perform acceptable, quality serial spirometry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304628

Contacts
Contact: Robert Jordan 609.495.2200 rjordan@palatin.com

Locations
United States, New Jersey
Not yet recruiting
Cranbury, New Jersey, United States
Sponsors and Collaborators
Palatin Technologies
  More Information

No publications provided

Responsible Party: Palatin Technologies
ClinicalTrials.gov Identifier: NCT01304628     History of Changes
Other Study ID Numbers: PL-3994-501
Study First Received: February 22, 2011
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Palatin Technologies:
asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014