A Phase 2 interventional study of albuterol inhalation powder and albuterol inhalation powder in Asthma and Bronchospasm, sponsored by Amphastar Pharmaceuticals, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-04-19.
Sponsored by Amphastar Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover and dose-ranging design. This study aims to evaluate the efficacy and initial safety profiles, and to identify the optimum dose of A006, from a select dose-range for future clinical PK/PD and Phase III studies. This study is to be conducted in generally healthy, adult subjects who have mild-to-moderate persistent asthma for at least 6 months prior to Screening.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 26 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Amphastar Pharmaceuticals, Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A006 albuterol inhalation powder, 120 mcg/inhalation, 1 inhalation
Drug: albuterol inhalation powder
A006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation
Drug: albuterol inhalation powder
A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations
Drug: albuterol inhalation powder
A006 albuterol inhalation powder 180 mcg/inhalation, 2 inhalations
Drug: albuterol inhalation powder
Placebo, 2 inhalations
Drug: Placebo
Proventil 90 mcg/inhalation, 2 inhalations
Drug: albuterol inhalation aerosol
Proventil 90 mcg/inhalation, 4 inhalations
Drug: albuterol inhalation aerosol
A006 albuterol inhalation powder, 120 mcg/inhalation, one inhalation
A006 albuterol inhalation powder, 180 mcg/inhalation, 1 inhalation
A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations
A006 albuterol inhalation powder, 180 mcg/inhalation, 2 inhalations
placebo, lactose inhalation carrier
albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations
Also known as: Proventil
albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations
Also known as: Proventil
AUC
Area under the curve (AUC) of post-dose FEV1 percentage changes from the Pre-dose Baseline. The primary analysis of the primary endpoint is to compare the AUC0-t of FEV1, between the A006 treatments and the Placebo Control.
Time frame: 5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose.
Time to Effect
Time to onset of bronchodilator effect
Time frame: 0 to 360 minutes
Peak Response
peak bronchodilator response
Time frame: 0 - 360 minutes
Duration
Duration of effect
Time frame: 0 - 360 minutes
Response Rate
Bronchodilatory Response Rate
Time frame: 0 - 360 minutes
Hand Tremor
Evaluation of hand tremor
Time frame: within 5 min. prior to dosing and 50 and 360 min post-dose.
Vital Signs
Pulse, heartrate, respirations, blood pressure
Time frame: within 15 min. prior to dosing, and 30, 90 and 360 min post-dose.
12 lead ECG
12-lead ECG for routine and QT/QTc evaluations
Time frame: within 15 min. prior to dosing and at 50 and 360 min postdose.
Blood Work
Collect blood samples (\~5 mL) for serum glucose and K+ tests
Time frame: within 15 min. prior to dosing, and 30 and 120 min. postdose
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Amphastar Pharmaceuticals, Inc.