- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03373409
Safety and Pharmacokinetics of Halix(TM) Albuterol Unit Dose Disposable Inhaler Versus Albuterol MDI
An Open-label, Single-Center, Single-Dose, 3-Way Crossover Study of the Safety and Pharmacokinetics of Albuterol Administered by the Halix(TM) Albuterol Unit Dose Disposable Inhaler
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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North Carolina
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Raleigh, North Carolina, United States, 27607
- North Carolina Clinical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:Subjects are required to meet ALL of the following inclusion criteria to be eligible for enrollment in the study.
- Has provided written informed consent
- Speaks and understands the English language
- Males or females 18 to 55 years of age (inclusive) at the Consent Visit
- Nonsmoker or ex-smoker who has abstained from smoking for at least 1 year prior to the Consent Visit and who has a ≤ 15 pack/year history of lifetime cigarette use
- Has no history of use of nicotine gum, nicotine patch, e-cigarettes/vaping preparations in the 3 months before the Consent Visit
- Has a body mass index (BMI) of 18.5 to 35.0 (calculated as kg/m2)
- Has never had a diagnosis of asthma, exercise-induced bronchospasm, chronic obstructive pulmonary disease, or other chronic respiratory disease or chronic upper airway condition (seasonal or perennial allergic rhinitis is not exclusionary; however, nasal polypectomy within the 12 months prior to the Screening Visit is exclusionary
- Has a FEV1 ≥ 80% of predicted normal for age, gender, height and ethnicity (percent of predicted normal values for FEV1 will be calculated using National Health and Nutrition Examination Survey III [NHANES III]) calculation at the Screening Visit
- Has a FEV1/FVC ratio ≥ 0.70 at the Screening Visit
- Ability to maintain a peak inspiratory flow rate of at least 60 L/min measured by the In-check DIAL device at the medium resistance setting.
- At the Screening Visit, demonstrates adequate understanding of and ability to successfully inhale from an MDI as determined by the investigator and through demonstrated successful use of the Vitalograph® aerosol inhalation monitor (AIM™) (training/validation device for MDI) using a placebo MDI canister.
[Note: potential subjects who cannot demonstrate successful MDI technique using with the AIM device (with placebo canister) after in-clinic training at the Screening Visit will not be eligible for continued participation in the study.] 12. At the Screening Visit, demonstrates adequate understanding of and ability to successfully inhale when using the Halix™ UDDI [Note: a placebo UDDI not containing any drug powder will be supplied for each potential subject to become familiar with the inhaler and practice inhalation technique] [Note: potential subjects who cannot demonstrate successful inhalation technique using the Halix™ UDDI after in-clinic training at the Screening Visit will not be eligible for continued participation in the study].
13. Willing and able to comply with all aspects of the study protocol including avoiding use of certain concomitant medications and attending the required clinic visits (ie, has no conflicting plans that would prohibit attendance at scheduled study visits including each of the threeTreatment Day Visits)
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Exclusion Criteria:Subjects will be excluded from participation in the study if ANY of the following criteria are present:
Female subjects of childbearing potential (CBP) who are not using reliable contraception (eg, abstinence, double barrier method, oral/implantable/transdermal contraception, Depo-Provera, intrauterine device); a woman is of CBP unless she is premenarchal, is at least 2 years postmenopausal, is without a uterus and/or both ovaries, has had a bilateral tubal ligation, or has undergone the Essure procedure with confirmation of tubal blockage.
[Note: If a female is identified as less than 2 years postmenopausal, a serum follicle-stimulating hormone (FSH) determination will be performed as a part of screening laboratory assessments. If a FSH result of < 40 mIU/mL is obtained, the female will be determined to be of CBP and her unwillingness to use reliable contraception as defined above will be exclusionary for the study.]
- A woman who is pregnant (has a positive serum pregnancy test at Screening), is lactating, or is likely/planning to become pregnant during the study
- Vital signs at the Screening Visit (after at least 2 minutes seated at rest) showing SBP either < 80 mmHg or >150 mmHg; DBP > 90 mmHg; or HR either < 40 bpm or > 100 bpm (vital signs outside these criteria may be repeated once after an additional seated rest period of at least 2 minutes- if vital signs exclusion criteria are not met after the repeat measurements of SBP, DBP, or HR, screening may continue)
- Emergency room visit or hospitalization for any acute respiratory condition in the 3 months prior to the Screening Visit
- Currently receiving pharmacologic treatment for diabetes or hypertension
- History of any acute or chronic hepatobiliary disorder or documented elevation of alanine transaminase (ALT) or aspartate transaminase (AST) 2 or more times the upper limit of the normal (ULN) laboratory reference range in the 12 months prior to the Consent Visit,
Clinical laboratory results (after ≥4 hours fasting) at the Screening Visit that show any one or more of the following:
- hemoglobin < 13.5 g/dL in male subjects; < 12 g/dL in female subjects
- hematocrit < 38 % in male subjects; <35% in female subjects
- total white blood cell count (WBC) < 2500 cells/mm3
- platelet count < 150,000 cells/mm3
- serum glucose < 80 mg/dL or > 120 mg/dL
- serum potassium < 3.5 mmol/L or > 5.2 mmol/L
- ALT or AST > 2.0 times ULN
- alkaline phosphatase (ALP) > 1.5 times ULN
- serum creatinine > 1.5 times ULN
- positive serum hCG (female subjects only)
- positive serologic test for HBsAg, anti-HCV antibody, or HIV antibody
- in the opinion of the investigator, a urinalysis result showing medically significant abnormality
- positive urine drug screen [Exception: urine drug screen detects evidence of an authorized prescribed medication]
- positive urine cotinine test
- Presence of any uncontrolled (in the Investigator's medical opinion) systemic disease, including, but not limited to renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or psychiatric disease
- Electrocardiogram obtained at Screening Visit that shows medically significant abnormalities (e.g., left bundle branch block, frequent premature ventricular contractions, chronic atrial fibrillation, or QTc interval prolongation > 450 msec for males and > 470 msec for females)
- Has a FEV1 < 80% of that predicted for age, gender, height, and ethnicity at the Screening Visit based on NHANES III calculation.
- Has a FEV1 / FVC ratio < 0.70
- Inability to maintain a peak inspiratory flow rate of 60 L/min or higher
- Presence of a current condition (e.g., alcoholism [or consumption of substantial quantities of alcohol], drug abuse, or psychiatric condition) making it unlikely that the requirements of the subject's participation in the protocol will be met
- History of allergic reaction (known hypersensitivity) to albuterol sulfate and/or lactose, in any formulation, or history of severe hypersensitivity to milk proteins
- Current participation in a drug, drug/device or biologic investigational research study or participation in a drug, drug/device or biologic investigational research study within the 30 days prior to the Screening Visit
- An elective surgical or medical procedure currently is planned or scheduled to be performed during the study (this excludes routine immunotherapy/desensitization procedures that are being performed on a regular schedule and have been unchanged for at least 3 months prior to the Screening Visit)
- Presence of a clinically diagnosed upper respiratory tract infection within the 14 days prior to the Screening Visit
Has undergone nasal polypectomy within the 12 months prior to the Screening Visit
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Albuterol DPI 90mcg
Participants will receive albuterol 90mcg via the albuterol DPI
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Albuterol unit dose disposable DPI delivers 90mcg of albuterol in the excipient lactose with each inhalation.
Albuterol 90mcg will be given on one of the 3 treatment days.
One inhalation from the DPI will be used.
Other Names:
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Experimental: Albuterol DPI 180mcg
Participants will receive albuterol 180mcg via the albuterol DPI
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Albuterol unit dose disposable DPI delivers 90mcg of albuterol in the excipient lactose with each inhalation.
Albuterol 180mcg will be given on one of the 3 treatment days.
Two inhalations from the DPI will be used to deliver the 180mcg dose
Other Names:
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Active Comparator: Albuterol HFA MDI
Participants will receive albuterol 180mcg via the HFA MDI inhaler
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Albuterol HFA MDI delivers 90mcg of albuterol with each inhalation.
Albuterol 180mcg will be given on one of the 3 treatment days.
Two inhalations from the MDI will be used to deliver the 180mcg dose
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced Expiratory Volume in 1 second (FEV1) before and after oral inhalation of albuterol on 3 different treatment days
Time Frame: At each of the 3 treatment visits, FEV1 (forced expiratory volume in one second) will be measured prior to drug administration and 6 times after dose- at 5 min, 15 min, 30 min, 45 min, 60 min and 120 min.
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Change from treatment day baseline in forced expiratory volume in one second (FEV1) will be assessed serially up to 120 minutes after each of 3 single doses of inhaled albuterol
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At each of the 3 treatment visits, FEV1 (forced expiratory volume in one second) will be measured prior to drug administration and 6 times after dose- at 5 min, 15 min, 30 min, 45 min, 60 min and 120 min.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic and diastolic blood pressure before and after oral inhalation of albuterol on 3 different treatement days
Time Frame: Serial measurements of systolic and diastolic blood pressure will be taken at baseline (15-40 mnutes pre-dose) and at 15, 30, 45, 60, 120 minutes post dose and at 3, 4, 5, 6, 10, 12, and 14 hours post-dose
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Change from treatment day baseline in blood pressure will be evaluated by the maximum change (systolic) and minimum change (diastolic) from baseline blood pressure, and the weighted mean change form baseline in systolic and diastolic blood pressure
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Serial measurements of systolic and diastolic blood pressure will be taken at baseline (15-40 mnutes pre-dose) and at 15, 30, 45, 60, 120 minutes post dose and at 3, 4, 5, 6, 10, 12, and 14 hours post-dose
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Serum potassium before and after oral inhalation of albuterol on 3 different treatment days
Time Frame: Serial measurments of serum potassium will be obtained at 10, 20, 30, 45, 60 and 120 minutes post-dose and 3 and 4 hours post-dose
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Change from treatment day baseline in serum potassium after each of 3 single doses of inhaled albuterol will be evaluated by the description of change from baseline values
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Serial measurments of serum potassium will be obtained at 10, 20, 30, 45, 60 and 120 minutes post-dose and 3 and 4 hours post-dose
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Serum glucose before and after oral inhalation of albuterol on 3 different treatment days
Time Frame: Serial measurments of serum potassium will be obtained at 10, 20, 30, 45, 60 and 120 minutes post-dose and 3 and 4 hours post-dose
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Change from treatment day baseline in serum glucose after each of 3 single doses of inhaled albuterol will be evaluated by the description of change from baseline values
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Serial measurments of serum potassium will be obtained at 10, 20, 30, 45, 60 and 120 minutes post-dose and 3 and 4 hours post-dose
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Electrocardiographic QTc interval before and after oral inhalation of albuterol on 3 different treatment days
Time Frame: Serial ECGs (electrocardiograms) will be taken at baseline (5-40 minutes pre-dose), 10 min post-dose, 50 min post-dose, and 5 hours post-dose.
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Change from treatment day baseline ECG (electrocardiogram) will assess the maximum and mean change from baseline of the corrected QT interval (QT measures the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle) following each of the 3 single doses of inhaled albuterol study drug.
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Serial ECGs (electrocardiograms) will be taken at baseline (5-40 minutes pre-dose), 10 min post-dose, 50 min post-dose, and 5 hours post-dose.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak plasma concentration (Cmax) of albuterol after oral inhalation on 3 different treatment days
Time Frame: PK samples to be collected postdose at 5, 10, 20, 30, 45, 60, and 120 minutes, and at 3, 4, 5, 6, 10, 12, and 14 hours post-dose
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Predose and post dose measurement of albuterol in plasma will be assessed after each of 3 single doses of inhaled albuterol.
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PK samples to be collected postdose at 5, 10, 20, 30, 45, 60, and 120 minutes, and at 3, 4, 5, 6, 10, 12, and 14 hours post-dose
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Area under the plasma concentration versus time (AUC0-t) of albuterol after oral inhalation on 3 different treatment days
Time Frame: PK samples to be collected postdose at 5, 10, 20, 30, 45, 60, and 120 minutes, and at 3, 4, 5, 6, 10, 12, and 14 hours post-dose
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Predose and post dose measurement of albuterol in plasma will be assessed after each of 3 single doses of inhaled albuterol.
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PK samples to be collected postdose at 5, 10, 20, 30, 45, 60, and 120 minutes, and at 3, 4, 5, 6, 10, 12, and 14 hours post-dose
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Area under the plasma concentration versus time to infinity (AUC0-inf) of albuterol after oral inhalation on 3 different treatment days
Time Frame: PK samples to be collected postdose at 5, 10, 20, 30, 45, 60, and 120 minutes, and at 3, 4, 5, 6, 10, 12, and 14 hours post-dose
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Predose and post dose measurement of albuterol in plasma will be assessed after each of 3 single doses of inhaled albuterol.
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PK samples to be collected postdose at 5, 10, 20, 30, 45, 60, and 120 minutes, and at 3, 4, 5, 6, 10, 12, and 14 hours post-dose
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Time to maximum plasma concentration (tmax) of albuterol after oral inhalation on 3 different treatment days
Time Frame: PK samples to be collected postdose at 5, 10, 20, 30, 45, 60, and 120 minutes, and at 3, 4, 5, 6, 10, 12, and 14 hours post-dose
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Predose and post dose measurement of albuterol in plasma will be assessed after each of 3 single doses of inhaled albuterol.
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PK samples to be collected postdose at 5, 10, 20, 30, 45, 60, and 120 minutes, and at 3, 4, 5, 6, 10, 12, and 14 hours post-dose
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Apparent terminal half-life (t 1/2) of albuterol after oral inhalation on 3 different treatment days
Time Frame: PK samples to be collected postdose at 5, 10, 20, 30, 45, 60, and 120 minutes, and at 3, 4, 5, 6, 10, 12, and 14 hours post-dose
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Predose and post dose measurement of albuterol in plasma will be assessed after each of 3 single doses of inhaled albuterol.
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PK samples to be collected postdose at 5, 10, 20, 30, 45, 60, and 120 minutes, and at 3, 4, 5, 6, 10, 12, and 14 hours post-dose
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Estimation of the terminal elimination rate constant (lambda z) of albuterol after oral inhalation on 3 different treatment days
Time Frame: PK samples to be collected postdose at 5, 10, 20, 30, 45, 60, and 120 minutes, and at 3, 4, 5, 6, 10, 12, and 14 hours post-dose
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Predose and post dose measurement of albuterol in plasma will be assessed after each of 3 single doses of inhaled albuterol.
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PK samples to be collected postdose at 5, 10, 20, 30, 45, 60, and 120 minutes, and at 3, 4, 5, 6, 10, 12, and 14 hours post-dose
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: William J Alexander, MD, Concentrx Pharmaceuticals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
Other Study ID Numbers
- CONX-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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