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The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.
This study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma for at least 6 months, but are otherwise generally healthy.
The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dose in comparison to the DPI Placebo Control and the Active (Reference) Control. The study results of this study together with that of A006-B study will be utilized to determine the optimum final dose range of A006 for further clinical studies.
The study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma but are otherwise generally healthy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T1 | Experimental | Two inhalations, one of Albuterol DPI 25 mcg/inh and one of Placebo DPI; Total Albuterol dose of 25 mcg |
|
| T2 | Experimental | Two inhalations of Albuterol DPI 25 mcg/inh; Total Albuterol dose of 50 mcg |
|
| T3 | Experimental | Two inhalations, one of Albuterol DPI 90 mcg/inh and one of Placebo DPI; Total Albuterol dose of 90 mcg |
|
| T4 | Experimental | Two inhalations of Albuterol DPI 90 mcg/inh; Total Albuterol dose of 180 mcg |
|
| P | Placebo Comparator | Two inhalations Placebo DPI; Total Albuterol dose of 0 mcg |
|
| R1 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuterol DPI 25 mcg/inh | Drug | Albuterol DPI with 25 mcg Albuterol/inhalation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1 Area Under the Curve (AUC) versus placebo | Serial FEV1 measurements to demonstrate the mean AUC change in percent FEV1 from same-day baseline of A006 versus placebo control | Visits 1-7, at baseline, 5, 20, 30, 60, 90, 120, 240, 360 minutes post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Placebo AUC of adjusted FEV1 changes | Determination of change of FEV1 in placebo arm | Visits 1-7 at baseline, 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose |
| AUC of post-dose FEV1 volume changes from pre-dose baseline to Visit 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Safety Monitor | Amphastar Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amphastar Site 0001 | San Jose | California | 95117 | United States | ||
| Amphastar Site 0025 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9695144 | Background | Lipworth BJ, Clark DJ. Lung delivery of salbutamol given by breath activated pressurized aerosol and dry powder inhaler devices. Pulm Pharmacol Ther. 1997 Aug;10(4):211-4. doi: 10.1006/pupt.1997.0093. | |
| 16185368 | Background | Ahrens RC. The role of the MDI and DPI in pediatric patients: "Children are not just miniature adults". Respir Care. 2005 Oct;50(10):1323-8; discussion 1328-30. |
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One inhalation of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 90 mcg
|
| R2 | Active Comparator | Two inhalations of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 180 mcg |
|
| Albuterol DPI 90 mcg/inh |
| Drug |
Albuterol DPI with 90 mcg Albuterol/inhalation |
|
| Placebo DPI | Drug | Placebo DPI with 0 mcg Albuterol/inhalation |
|
| Albuterol MDI 90 mcg/inh | Drug | Albuterol MDI with 90 mcg Albtuerol/inhalation |
|
Determination of FEV1 volume change from pre-dose baseline to post treatment at Visit 7
| Visits 1-7 at baseline, 5, 20, 30, 60, 90, 120, 180, 240, 360 minutes post-dose |
| Time post-dose change in FEV1 percent first reaches greater than or equal to 12 percent over the Pre-dose Baseline | Time to onset of bronchodilator effect (Tonset), determined by linear interpolation as the point where post-dose change in FEV1 percent first reaches greater than or equal to 12 percent over the Pre-dose Baseline. | Visits 1-7, at 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose |
| Peak bronchodilator response (Fmax) | The peak bronchodilator response (Fmax), defined as the maximum post-dose change in FEV1 percent. | Visits 1-7 at 5, 20, 30, 60, 90, 120, 180, 240, 360 minutes post-dose |
| Time to peak FEV1 effect (tmax) | The time to peak FEV1 effect (tmax), defined as the time of Fmax. | Visits 1-7 at 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose |
| Duration of effect | Duration of effect, calculated as the total duration of bronchodilator effects when change in FEV1 percent is greater than or equal to 12 percent above baseline. | Visits 1-7 at 5, 20, 30, 60, 90, 120, 180 and 360 minutes post-dose |
| Bronchodilatory Response Rate (R percent) | Evaluation of Bronchodilatory Response Rate (R percent) of responders who demonstrate a greater than or equal to 12 percent increase for change in FEV1 percent during the initial 60 min post-dose. | Visits 1-7 at 60 minutes |
| Dose response curve: AUC of change in percent FEV1 versus Dose | Evaluation of change in FEV1 in relation to dose. | Visits 1-7 |
| Vital Signs (i.e.: blood pressure and heart rate) | Vital signs, i.e. blood pressure (SBP/DBP) and heart rate (HR), at pre-dose baseline, and 3, 8, 15, 30, 90, and 360 min post-dose. | Visits 1-7 and EOS at baseline, 3, 8, 15, 30, 90 and 360 minutes post-dose |
| 12-lead ECG (for routine and QT/QTc) | Measurement of 12-lead ECG (for routine and QT/QTc), at pre-dose baseline, and at 10, 50, and 360 min post-dose. | Visits 1-7 at baseline, 10, 50 and 360 minutes post-dose |
| Serum glucose | Determination of Serum glucose, at pre-dose baseline, and at 15, 35 and 120 min post-dose. | Visits 1-7 at baseline, 15, 35 and 120 minutes post-dose |
| Serum potassium | Determination of serum potassium levels, at pre-dose baseline, and at 15, 35 and 120 min post-dose. | Visits 1-7 at baseline, 15, 35 and 120 minutes post-dose |
| Asthma exacerbation incidents | Evaluation of asthma exacerbation incidents in all patients throughout the duration of the study. | Visits 1-7 and EOS |
| Asthma management/ rescue drug usage | Evaluation of asthma exacerbation incidents in all patients throughout the duration of the study. | Visits 1-7 and EOS |
| Physical examination | Physical examination of all subjects performed at screening and end-of-study visit to evaluate subject's general health. | Screening and End-of-Study Visit |
| CBC | Evaluation of CBC in all subjects at screening and end-of-study visit. | Screening and End-of-Study Visit |
| Comprehensive metabolic panel | Comprehensive metabolic panel performed on all subjects at screening and end-of-study visit. | Screening and End-of-Study Visit |
| Urinalysis | Urinalysis performed on all subjects at screening and end-of-study visit. | Screening and End-of-Study Visit |
| Pregnancy test | A pregnancy test for women of child bearing potential at screening and end-of-study visit. | Screening and End-of-Study Visit |
| Medication interactions | Evaluation of concomitant medications used by subjects throughout the study and their potential to affect the study | Screening, Visits 1-7 and End-of-Study Visit |
| Number of participants with adverse events as a measure of safety and tolerability | Adverse drug events whether observed by investigators or reported by subjects, will be documented, evaluated, followed up, and treated if deemed necessary. | Screening, Visits 1-7, End-of-Study Visit |
| Medford |
| Oregon |
| 97504 |
| United States |
| Amphastar Site 0030 | New Braunfels | Texas | 78130 | United States |
| Amphastar Site 0032 | San Antonio | Texas | 78229 | United States |
| 3653233 | Background | Goldstein DA, Tan YK, Soldin SJ. Pharmacokinetics and absolute bioavailability of salbutamol in healthy adult volunteers. Eur J Clin Pharmacol. 1987;32(6):631-4. doi: 10.1007/BF02456001. |
| 7874928 | Background | Hindle M, Newton DA, Chrystyn H. Dry powder inhalers are bioequivalent to metered-dose inhalers. A study using a new urinary albuterol (salbutamol) assay technique. Chest. 1995 Mar;107(3):629-33. doi: 10.1378/chest.107.3.629. |
| 7271065 | Background | Crapo RO, Morris AH, Gardner RM. Reference spirometric values using techniques and equipment that meet ATS recommendations. Am Rev Respir Dis. 1981 Jun;123(6):659-64. doi: 10.1164/arrd.1981.123.6.659. |
| 7074238 | Background | Crapo RO, Morris AH, Clayton PD, Nixon CR. Lung volumes in healthy nonsmoking adults. Bull Eur Physiopathol Respir. 1982 May-Jun;18(3):419-25. |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007538 | Isoniazid |
| ID | Term |
|---|---|
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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