HealthyPhase 1NCT02566252
Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042)
A Phase 1 study testing PUL-042 Inhalation Solution, Cromolyn Sodium and Albuterol sulfate in people with Healthy, run by Pulmotect, Inc. at 1 site in United States.
Trial summary
This study evaluates the effect of pre-treatment with either cromolyn sodium or albuterol sulfate on the safety and tolerability or PUL-042 Inhalation Solution in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PUL-042 Inhalation Solution, Cromolyn Sodium and Albuterol sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Mar 2016
- 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
- Males or females of non-childbearing potential (defined as surgically sterilized [tubal ligation/hysterectomy/bilateral salpingo oophorectomy or post- menopausal for > 2 years) with a negative urine human chorionic gonadotropin (hCG) pregnancy test at the Screening Visit
- Body Mass Index (BMI) between 18 and 30 kg/m2
- Ability to perform spirometry according to American Thoracic Society standards
- Normal spirometry (forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC] ≥ 80% and ≤ 120% based on predicted values) at the Screening Visit and at Visit 2.
- Pulse oximetry ≥95% on room air
- Ability to understand and give informed consent
- Males willing to practice contraception (condom + spermicide) during the study and for 30 days after completion of the
Who cannot join
- Febrile (temperature ≥ 99.5°Fahrenheit)
- A history of use of any tobacco products during the year prior to the Screening Visit and a total exposure of > 5 pack years or a positive urine cotinine level at the Screening Visit
- Clinically significant laboratory finding as determined by the Principal Investigator or designee at the Screening Visit or at Visit 2
- Positive test for drugs of abuse (alcohol, cannabinoids, opiates, cocaine, amphetamine, barbiturates, benzodiazepine, phencyclidine)
- Any active medical problems requiring treatment
- Subjects who exhibit symptoms of respiratory infection or have experienced respiratory symptoms of an upper respiratory infection within 30 days prior to the Screening Visit.
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- History of chronic pulmonary disease (eg, asthma [including atopic asthma, exercise induced asthma, or asthma triggered by respiratory infection], pulmonary fibrosis), pulmonary hypertension, or heart failure
- Any out of range QTc Fridericia (QTcF) or other clinically significant ECG findings as determined by the Principal Investigator or designee at Visit 2 or Visit 12.
- History of atopic reactions
- Administration of any anti-inflammatory therapy (eg, no steroidal anti-inflammatory drugs or corticosteroids) within 4 weeks prior to randomization or expected to be ongoing during the study
- An anticipated need for use of any inhaled medication during the study
- Intake of coffee, tea, cola drinks, chocolate on days of Study Visits 1-21
- Intake of alcohol, caffeine or strenuous exercise within 72 hours prior to study drug administration or intake of grapefruit within 7 days prior to the administration of study drug
- Intake of alcohol within 4 hours of spirometry; smoking within 1 hour of spirometry; performing vigorous exercise within 30 minutes of spirometry; wearing clothing that substantially restricts full chest and abdominal expansion; or eating a large meal within 2 hours of spirometry
- Administration of any over the counter (OTC)/prescription medication, supplements, herbals or vitamins within 14 days prior to study drug administration. Administration of Tylenol within 72 hours of study drug administration (doses up to 2g/day will be allowed prior to 72 hours before study drug administration)
- Exposure to any investigational agent within 30 days prior to the Screening Visit
- Receipt of a flu vaccine in the last 3 months
- Prior exposure to PUL-042
- Known positive for human immunodeficiency virus, or on active anti-retroviral therapy and known hepatitis B surface antigen positive or hepatitis C positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Crossover Study to Assess the Safety, Tolerability, and Pharmacodynamics of PUL-042 Inhalation Solution in Healthy Subjects and the Effect of Pretreatment With Cromolyn Sodium or Albuterol Sulfate
This study evaluates the effect of pre-treatment with either cromolyn sodium or albuterol sulfate on the safety and tolerability or PUL-042 Inhalation Solution in healthy subjects.
Read the detailed description
Healthy subjects (8 per cohort) will be randomized to either pre-treatment or no pre-treatment (4 per group). The initial cohort will receive pre-treatment with cromolyn sodium. Subjects will be followed for 2 weeks for safety and tolerability, undergo a 2 week washout period and then be assigned to the alternative treatment (i.e., subjects who received cromolyn sodium prior to PUL-042 inhalation solution will not receive pretreatment) and then followed for an additional 2 weeks.
Subsequent cohort will receive pre-treatment with albuterol sulfate in a like manner.
- Conditions
- Healthy
- Being tested
- PUL-042 Inhalation Solution, Cromolyn Sodium, Albuterol sulfate
- Keywords
- Safety, tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUL-042 Inhalation SolutionDrug
PUL-042
Cromolyn SodiumDrug
Pre-treatment
Albuterol sulfateDrug
Pre-treatment
| Study group | Role | What they receive |
|---|---|---|
| PUL-042 | Experimental | PUL-042 Inhalation Solution Receives: Drug: PUL-042 Inhalation Solution |
| Cromolyn sodium | Experimental | Pre-Treatment with cromolyn sodium followed by PUL-042 Inhalation Solution Administration Receives: Drug: PUL-042 Inhalation Solution; Drug: Cromolyn Sodium |
| Albuterol sulfate | Experimental | Pre-Treatment with albuterol sulfate followed by PUL-042 Inhalation Solution Administration Receives: Drug: PUL-042 Inhalation Solution; Drug: Albuterol sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent, treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmotect, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WCCT Global
- Responsible party
- Sponsor
- Investigators
- Michelle Ababa, MD, Principal investigator, West Coast Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566252
- Sponsor's protocol ID
- PUL-042-003
- Status last verified
- Aug 2017
- First submitted
- 29 Sep 2015
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Crossover Study to Assess the Safety, Tolerability, and Pharmacodynamics of PUL-042 Inhalation Solution in Healthy Subjects and the Effect of Pretreatment With Cromolyn Sodium or Albuterol Sulfate
- ClinicalTrials.gov ID
- NCT02566252
- Acronym / sponsor ID
- PUL-042-003
- Conditions
- Healthy
- Keywords
- Safety, tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Pulmotect, Inc.Industry (pharma, biotech, devices)
- Collaborators
- WCCT Global
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Oct 2015 (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 evaluates the effect of pre-treatment with either cromolyn sodium or albuterol sulfate on the safety and tolerability or PUL-042 Inhalation Solution in healthy subjects.
Detailed description
Healthy subjects (8 per cohort) will be randomized to either pre-treatment or no pre-treatment (4 per group). The initial cohort will receive pre-treatment with cromolyn sodium. Subjects will be followed for 2 weeks for safety and tolerability, undergo a 2 week washout period and then be assigned to the alternative treatment (i.e., subjects who received cromolyn sodium prior to PUL-042 inhalation solution will not receive pretreatment) and then followed for an additional 2 weeks.
Subsequent cohort will receive pre-treatment with albuterol sulfate in a like manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PUL-042 | Experimental | Drug: PUL-042 Inhalation SolutionPUL-042 Inhalation Solution |
| Cromolyn sodium | Experimental | Drug: PUL-042 Inhalation Solution, Drug: Cromolyn SodiumPre-Treatment with cromolyn sodium followed by PUL-042 Inhalation Solution Administration |
| Albuterol sulfate | Experimental | Drug: PUL-042 Inhalation Solution, Drug: Albuterol sulfatePre-Treatment with albuterol sulfate followed by PUL-042 Inhalation Solution Administration |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males or females of non-childbearing potential (defined as surgically sterilized [tubal ligation/hysterectomy/bilateral salpingo oophorectomy or post- menopausal for > 2 years) with a negative urine human chorionic gonadotropin (hCG) pregnancy test at the Screening Visit
- Body Mass Index (BMI) between 18 and 30 kg/m2
- Ability to perform spirometry according to American Thoracic Society standards
- Normal spirometry (forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC] ≥ 80% and ≤ 120% based on predicted values) at the Screening Visit and at Visit 2.
- Pulse oximetry ≥95% on room air
Key exclusion criteria (19 listed)
- Febrile (temperature ≥ 99.5°Fahrenheit)
- A history of use of any tobacco products during the year prior to the Screening Visit and a total exposure of > 5 pack years or a positive urine cotinine level at the Screening Visit
- Clinically significant laboratory finding as determined by the Principal Investigator or designee at the Screening Visit or at Visit 2
- Positive test for drugs of abuse (alcohol, cannabinoids, opiates, cocaine, amphetamine, barbiturates, benzodiazepine, phencyclidine)
- Any active medical problems requiring treatment
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 |
|---|---|---|
| PUL-042 Inhalation SolutionPUL-042 | Drug | Albuterol sulfate, Cromolyn sodium, PUL-042 |
| Cromolyn SodiumPre-treatment | Drug | Cromolyn sodium |
| Albuterol sulfatePre-treatment | Drug | Albuterol sulfate |
Primary outcome
Number of participants with treatment emergent, treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)
Time frame: 6 weeks
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 10 Aug 2017.
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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.
Michelle Ababa, MD principal investigator
West Coast Clinical Trials
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 PUL-042 Inhalation Solution, Cromolyn Sodium and Albuterol sulfate in people with Healthy, run by Pulmotect, 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 7 inclusion and 19 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 10 Aug 2017. 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. 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?
Number of participants with treatment emergent, treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (time frame: 6 weeks). 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 10 Aug 2017.