Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation
NCT ID: NCT02210806
Last Updated: 2017-04-19
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2014-07-31
2014-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation
NCT01581177
Dose-Ranging Study of A006 DPI, in Adult Asthma Patients
NCT01174732
Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers
NCT02271334
Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006
NCT01189396
A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics
NCT02126839
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment T1
One inhalation of 110 mcg A006 DPI. Total 110 mcg.
A006 DPI
Single dose 110 mcg, 1 inhalation
Treatment T2
One inhalation of 220 mcg A006 DPI. Total 220 mcg.
A006 DPI
Single dose 220 mcg, 1 inhalation
Placebo
One inhalation of placebo DPI . Total 0 mcg
Placebo DPI
Placebo, 1 inhalation
Treatment R1
One inhalation of Proventil® MDI Total 90 mcg
Proventil® MDI
Single dose 90 mcg, 1 inhalation
Treatment R2
Two inhalations of Proventil® MDI, 180 mcg total
Proventil® MDI
Single dose 90 mcg, 2 inhalations
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
A006 DPI
Single dose 110 mcg, 1 inhalation
A006 DPI
Single dose 220 mcg, 1 inhalation
Placebo DPI
Placebo, 1 inhalation
Proventil® MDI
Single dose 90 mcg, 1 inhalation
Proventil® MDI
Single dose 90 mcg, 2 inhalations
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* With mild-to-moderate persistent asthma for at least 6 months prior to Screening, and having used inhaled β-agonist(s) for asthma control
* Demonstrating a Screening Baseline FEV1 at 50.0 - 85.0% of predicted normal
* Demonstrating a ≥ 15.0% Airway Reversibility in FEV1 within 30 min after inhaling 2 actuations of Proventil® MDI (180 mcg) at Screening
* Demonstrating Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training), for at least 2 times consecutively with a maximum of 5 attempts
* Demonstrating proficiency in the use of a DPI and an MDI after training
* Females of child-bearing potential must be non-pregnant, non-lactating; both males and females enrolled into the study must agree to practice a clinically acceptable form of birth control (including but not limited to, abstinence, double barrier, etc)
* Having properly consented to participate in the trial
Exclusion Criteria
* Upper respiratory tract infections or lower respiratory tract infection within 6 weeks, prior to Screening
* Asthma exacerbations that required emergency care or hospitalized treatment, within 4 weeks prior to Screening
* Any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases besides asthma
* Concurrent clinically significant cardiovascular (e.g. hypertension and tachyarrhythmia and bradyarrhythmia), hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant, or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study
* Known intolerance or hypersensitivity to any of the ingredients of the study drug DPI or Proventil® HFA MDI (i.e., Albuterol, sulfate, lactose, milk protein, HFA-134a, oleic acid, and ethanol)
* Baseline ECG at Screening or Visit 1 showing any single or multiple premature ventricular contractions (PVC)
* Baseline ECG at Screening or Visit 1 with a confirmed (through performing a second ECG) QTc reading greater than 450ms
* Use of prohibited drugs or failure to observe the drug washout restrictions
* Having been on other clinical drug/device studies in the last 30 days prior to Screening.
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amphastar Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Safety Monitor
Role: STUDY_DIRECTOR
Amphastar Pharmeceuticals, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.
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
Review additional registry numbers or institutional identifiers associated with this trial.
API-A006-CL-B3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.