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Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation

Information source: Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: A006 DPI (Drug); A006 DPI (Drug); Placebo DPI (Other); Proventil® MDI (Drug); Proventil® MDI (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Amphastar Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Study Director, Study Director, Affiliation: Amphastar Pharmeceuticals, Inc.

Summary

This study evaluates the efficacy, dose-ranging and safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 110 to 220 mcg per dose in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.

Clinical Details

Official title: Efficacy, Dose-ranging and Safety Evaluation (A Randomized, Double- or Evaluator-blinded, Active- and Placebo-controlled, Single Dose, Five-arm, Crossover, and Dose-ranging Study of A006 in Adult Asthma Patients)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Area Under the Curve (AUC[0-6h]) of Post-Dose FEV1 Percentage Change (∆%FEV1) from the Same-Day Pre-Dose Baseline

Secondary outcome:

Area Under the Curve (AUC[0-6h]) of Placebo Adjusted Post-Dose FEV1 Percentage Change (∆∆%FEV1) from the Same-Day Pre-Dose Baseline

Area Under the Curve (AUC[0-6h]) of Post-Dose FEV1 Volume Changes (∆FEV1) from the Same-Day Pre-Dose Baseline

Time to Onset of Bronchodilator Effect (t[onset])

Peak Bronchodilator Response (F[max])

Time to Peak ∆FEV1 Effect (t[max])

Area Under the Curve (AUC[0-6h]) of Post-Dose FEV1 in Volume from the Same-Day Pre-Dose Baseline

F[max] of Post-Dose FEV1 in Volume

Efficacy Duration-1

Efficacy Duration-2

Efficacy Duration-3

Bronchodilator Response

Dose Response Curve

Detailed description: This study is designed to evaluate the efficacy and safety profiles of A006 and to assist in identifying the optimum dose of A006 for future clinical studies. Proventil® HFA MDI, a currently marketed Albuterol MDI product, will be used as an Active Control. The study also employs a Placebo Control DPI, which has the same configuration as the A006 DPI except that it contains no active ingredient.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Generally healthy, male and female adults, 18-55 years of age at Screening

- 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:

- A smoking history of ≥ 5 pack-years, or having smoked within 6 months prior to

Screening

- 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.

Locations and Contacts

Allergy and Asthma Associates of Santa Clara Valley Research Center, San Jose, California 95117, United States

The Clinical Research Institute of Southern Oregon, PC, Medford, Oregon 97504, United States

Central Texas Health Research, New Braunfels, Texas 78130, United States

Sylvana Research Associates, San Antonio, Texas 78229, United States

Additional Information

Related publications:

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.

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. Review.

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.

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.

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.

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.

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.

Starting date: July 2014
Last updated: October 20, 2014

Page last updated: August 23, 2015

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