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Trial record 80 of 857 for:    ALBUTEROL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02566252
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : August 10, 2017
WCCT Global
Information provided by (Responsible Party):
Pulmotect, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PUL-042 Inhalation Solution Drug: Cromolyn Sodium Drug: Albuterol sulfate Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: PUL-042
PUL-042 Inhalation Solution
Drug: PUL-042 Inhalation Solution

Experimental: Cromolyn sodium
Pre-Treatment with cromolyn sodium followed by PUL-042 Inhalation Solution Administration
Drug: PUL-042 Inhalation Solution

Drug: Cromolyn Sodium

Experimental: Albuterol sulfate
Pre-Treatment with albuterol sulfate followed by PUL-042 Inhalation Solution Administration
Drug: PUL-042 Inhalation Solution

Drug: Albuterol sulfate

Primary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. Effect of pre-treatment with cromolyn sodium or albuterol sulfate on serial forced expiratory volume in 1 second (FEV1) from 0-8 hours post PUL-042 administration [ Time Frame: 8 hours ]
    Area under the FEV1 curve from dosing until 8 hours post-dose (AUC0-8)

  2. Number of participants with FEV1 decrease of > 12% compared to pred-dose baseline [ Time Frame: 2 weeks ]
    Serial measurements of FEV1

  3. Number of participants with absolute neutrophil count (ANC) outside the normal range [ Time Frame: 2 weeks ]
    Serial measurements of ANC

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02566252

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United States, California
WCCT Global
Cypress, California, United States, 90630
Sponsors and Collaborators
Pulmotect, Inc.
WCCT Global
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Principal Investigator: Michelle Ababa, MD West Coast Clinical Trials

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Responsible Party: Pulmotect, Inc. Identifier: NCT02566252     History of Changes
Other Study ID Numbers: PUL-042-003
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Keywords provided by Pulmotect, Inc.:
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Cromolyn Sodium
Pharmaceutical Solutions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action