AsthmaPhase 2NCT01304628
Cross-Over Study of Subcutaneous Study Drug for the Treatment of Patients With Mild to Moderate Asthma
A Phase 2 study testing PL-3994 in people with Asthma, run by Palatin Technologies, Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- PL-3994
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Asthma
- Being tested
- PL-3994
- Keywords
- asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PL-3994Drug
subcutaneous PL-3994, single dose, 4 escalating dose groups
| Study group | Role | What they receive |
|---|---|---|
| PL-3994 (4 escalating doses) | Experimental | Not described Receives: Drug: PL-3994 |
| Placebo | Placebo comparator | Not described Receives: Drug: PL-3994 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Expiratory Volume in one second (FEV1)
Serial spirometry measures, including FEV1, assessed at specified time periods over 12 hours post dose.
Measured: Throughout 12 hours post dosing
Secondary outcomes (1)
Change in Forced Vital Capacity (FVC)
Serial spirometry measures, including FVC, assessed at specified time periods over 12 hours post dose.
Measured: Throughout 12 hours post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
Why it stopped: Sponsor terminated study prior to initiation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palatin Technologies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304628
- Sponsor's protocol ID
- PL-3994-501
- Status last verified
- Dec 2014
- First submitted
- 22 Feb 2011
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01304628
- Acronym / sponsor ID
- PL-3994-501
- Conditions
- Asthma
- Keywords
- asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor terminated study prior to initiation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Palatin Technologies, IncIndustry (pharma, biotech, devices)
- First posted
- 25 Feb 2011 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PL-3994 (4 escalating doses) | Experimental | Drug: PL-3994 |
| Placebo | Placebo comparator | Drug: PL-3994 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (30 listed)
- Current diagnosis, as per subject or investigator or screening assessment, of:
- 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%)
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 |
|---|---|---|
| PL-3994subcutaneous PL-3994, single dose, 4 escalating dose groups | Drug | PL-3994 (4 escalating doses), Placebo |
Primary outcome
Change in Forced Expiratory Volume in one second (FEV1)
Time frame: Throughout 12 hours post dosing
Serial spirometry measures, including FEV1, assessed at specified time periods over 12 hours post dose.
1 secondary outcome
Change in Forced Vital Capacity (FVC)
Time frame: Throughout 12 hours post dosing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PL-3994 in people with Asthma, run by Palatin Technologies, 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 9 inclusion and 30 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: withdrawn, as of the sponsor's last update on 16 Dec 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Forced Expiratory Volume in one second (FEV1) (time frame: Throughout 12 hours post dosing). 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 16 Dec 2014.