Expired Study
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Cypress, California 90630


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.

Study summary:

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.


Inclusion Criteria: - 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 Exclusion Criteria: - 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. - 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

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042)

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

Overall Status:


Study Phase:

Phase 1



Minimum Age:

18 Years

Maximum Age:

55 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pulmotect, Inc.

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Michelle Ababa, MD
Principal Investigator
West Coast Clinical Trials

Study Dates

Start Date:July 2015
Completion Date:March 2016
Completion Type:Actual
Primary Completion Date:January 2016
Primary Completion Type:Actual
Verification Date:August 2017
Last Changed Date:August 8, 2017
First Received Date:September 29, 2015

Study Outcomes

Outcome Type: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:PUL-042 Inhalation Solution
Arm Name:PUL-042
Intervention Type:Drug
Name:Cromolyn Sodium
Arm Name:Cromolyn sodium
Intervention Type:Drug
Name:Albuterol sulfate
Arm Name:Albuterol sulfate

Study Arms

Study Arm Type:Experimental
Arm Name:Albuterol sulfate
Description:Pre-Treatment with albuterol sulfate followed by PUL-042 Inhalation Solution Administration
Study Arm Type:Experimental
Arm Name:Cromolyn sodium
Description:Pre-Treatment with cromolyn sodium followed by PUL-042 Inhalation Solution Administration
Study Arm Type:Experimental
Arm Name:PUL-042
Description:PUL-042 Inhalation Solution

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pulmotect, Inc.
Agency Class:Industry
Agency Type:Collaborator
Agency Name:WCCT Global

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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