Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation
NCT ID: NCT01581177
Last Updated: 2017-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2012-04-30
2012-08-31
Brief Summary
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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.
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Detailed Description
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The study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma but are otherwise generally healthy.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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T1
Two inhalations, one of Albuterol DPI 25 mcg/inh and one of Placebo DPI; Total Albuterol dose of 25 mcg
Placebo DPI
Placebo DPI with 0 mcg Albuterol/inhalation
Albuterol DPI 25 mcg/inh
Albuterol DPI with 25 mcg Albuterol/inhalation
T2
Two inhalations of Albuterol DPI 25 mcg/inh; Total Albuterol dose of 50 mcg
Albuterol DPI 25 mcg/inh
Albuterol DPI with 25 mcg Albuterol/inhalation
T3
Two inhalations, one of Albuterol DPI 90 mcg/inh and one of Placebo DPI; Total Albuterol dose of 90 mcg
Placebo DPI
Placebo DPI with 0 mcg Albuterol/inhalation
Albuterol DPI 90 mcg/inh
Albuterol DPI with 90 mcg Albuterol/inhalation
T4
Two inhalations of Albuterol DPI 90 mcg/inh; Total Albuterol dose of 180 mcg
Albuterol DPI 90 mcg/inh
Albuterol DPI with 90 mcg Albuterol/inhalation
P
Two inhalations Placebo DPI; Total Albuterol dose of 0 mcg
Placebo DPI
Placebo DPI with 0 mcg Albuterol/inhalation
R1
One inhalation of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 90 mcg
Albuterol MDI 90 mcg/inh
Albuterol MDI with 90 mcg Albtuerol/inhalation
R2
Two inhalations of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 180 mcg
Albuterol MDI 90 mcg/inh
Albuterol MDI with 90 mcg Albtuerol/inhalation
Interventions
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Placebo DPI
Placebo DPI with 0 mcg Albuterol/inhalation
Albuterol MDI 90 mcg/inh
Albuterol MDI with 90 mcg Albtuerol/inhalation
Albuterol DPI 25 mcg/inh
Albuterol DPI with 25 mcg Albuterol/inhalation
Albuterol DPI 90 mcg/inh
Albuterol DPI with 90 mcg Albuterol/inhalation
Eligibility Criteria
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Inclusion Criteria
* With mild-to-moderate persistent asthma for at least 6 months prior to screening and having used a beta-agonist(s) inhaler
* Demonstrate a Forced Expiratory Volume (FEV1) at 50-85 percent of predicted normal during screening baseline measurement
* Demonstrate an airway reversibility of greater than or equal to 15 percent within 30 minutes of inhaling 2 inhalations of Proventil MDI during screening visit
* Demonstrate Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training), at least 2 times consecutively
* Demonstrate ability to use a DPI and MDI inhaler properly after training
* Females must be not pregnant, not lactating, and using a clinically acceptable form of birth control
* Properly agree to participate in the trial
Exclusion Criteria
* Upper respiratory tract infections within 2 weeks or lower respiratory tract infection within 4 weeks prior to screening visit
* Asthma exacerbations that required emergency care or a hospital stay within 4 weeks prior to screening visit
* Any current or recent respiratory tract infections that might affect the response to the study drug as determined by the investigator, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema and other significant respiratory diseases besides asthma
* Current clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant or other illnesses that could impact the study as determined by the investigator
* Known intolerance or hypersensitivity to any ingredients of the study drug DPI or Proventil MDI (i.e.: Albuterol, sulfate, lactose, milk protein, HFA-134a, oleic acid and ethanol)
18 Years
55 Years
ALL
No
Sponsors
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Amphastar Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Safety Monitor
Role: STUDY_DIRECTOR
Amphastar Pharmaceuticals, Inc.
Locations
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Amphastar Site 0001
San Jose, California, United States
Amphastar Site 0025
Medford, Oregon, United States
Amphastar Site 0030
New Braunfels, Texas, United States
Amphastar Site 0032
San Antonio, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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API-A006-CL-B2
Identifier Type: -
Identifier Source: org_study_id
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