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Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients

Information source: Amphastar Pharmaceuitcals, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: albuterol HFA (Armstrong's) (Drug); albuterol HFA (Proventil HFA) (Drug); HFA placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Amphastar Pharmaceuitcals, Inc.

Summary

This 12-week clinical study evaluates the safety and efficacy of Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA, or: A004), Armstrong's proposed HFA formulation of metered dose inhaler (MDI) of Albuterol (Treatment T), in comparison with:

1. Placebo control: (HFA propellant only, Treatment P); and

2. Active control: 3M/Key's Proventil-HFA (Treatment R).

The treatments will be given as self-administered oral inhalations in adult and adolescent patients with mild-to-moderate asthma, for 12-weeks. Dosing regimen throughout the 12-week study is two actuations four times daily (QID).

Clinical Details

Official title: Randomized, Placebo-Controlled, Parallel, Multi-Center, 12-Week Study to Evaluate the Efficacy and Safety of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Adult and Adolescent Asthmatic Patients

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary endpoint is the bronchodilator effect expressed as the mean area under the curve (AUC) of FEV1 (% change from Same-Day Baseline FEV1) versus time.

Secondary outcome:

The comparative analysis of AUC of FEV1 (% change from the Same-Day Baseline) versus time, for bronchodilator effect (between Albuterol-HFA and Proventil-HFA).

AUC of FEV1-time curve (changes of actual volumes from the Same-Day Baseline).

Time to onset of bronchodilator effect, determined by linear interpolation as the time point where FEV1 first reaches 12% over Same-Day Baseline.

The peak bronchodilator response, defined as the maximum FEV1 (% change from Same-Day Baseline) post-dose.

The time to peak FEV1 effect, measured as the time point of peak response, as defined (4) above.

Duration of bronchodilator effect, defined as the total length of time when FEV1 is maintained 12% above the respective Same-Day Baseline values (time points calculated with linear interpolation).

Percentage of positive responders including those whose FEV1 exceed the Same-Day Baseline by 12% within 30 minutes post-dose (quick responders), and during the entire 6 hr post-dose (overall responders).

Number of inhalations of the rescue inhalers taken.

Global assessment of Overall Asthma Control Scores by investigators.

Total daytime asthma symptom scores.

Nighttime sleep disturbance scores.

Morning pre-dose Peak Expiratory Flow Rate (PEF).

The clinical performances of the Albuterol-HFA MDI at the representative first, middle and last one third of the usable life stage, are compared with each other, and are also compared to those of the active control, Proventil-HFA.

The in vitro performance of the Albuterol-HFA MDI will be evaluated.

Vital signs (SBP/DBP, and heart rate) will be monitored at Clinical Visit 1, 3 and 5, at baseline (within 30 minutes prior to dosing), and 90+/-15 min, and 360+/-30 min, post-dose.

A 12-lead ECG (for HR, QT and QTc intervals) will be recorded at Screening Visit, and at baseline (within 30 min) pre-dose and at 90+/-15 min post-dose (predicted time of peak effect).

Data for CBC, blood chemistry panel (8-hr fasted), and urinalysis.

Study compliance and diaries will be reviewed

Concomitant medications will be reviewed and recorded

Adverse events/side effects whether observed by investigators or reported by subjects, will be documented, evaluated, followed up, and treated if deemed necessary.

Detailed description: This is a randomized, parallel, multicenter, 12-week study in adolescent and adult patients with mild-to-moderate asthma, to evaluate the efficacy and safety of Armstrong's Albuterol-HFA MDI, in comparison to a Placebo Control and an Active Control of Proventil-HFA. While Albuterol-HFA (Treatment T) and Placebo (Treatment P) will be double-blinded to both the subjects and investigational staff, the active comparator drug, Proventil-HFA (Treatment R), can only be evaluator-blinded, due to: (1) its physical appearance differing from that of the T and P devices; and (2) unavailability of a Proventil-HFA placebo which would otherwise be used for a double-dummy design. All study medications will have the canisters and all product-identifying text or graphics (e. g., molded text on actuator) masked so that the treatments cannot be identified. No subject in any study arm will be given any information that could reveal the nature of the treatment given. All study subjects will be instructed not to reveal or discuss the study medications to the study staff or other subjects. The designated study evaluator(s), who conduct the clinical visits and safety and efficacy evaluations and perform the data recording and transcription, will be blinded to the study medications.

All subjects will be screened for enrollment, and will be randomized into the following three treatment groups in a double-blinded (for Treatments T and P) or evaluator-blinded (for Treatment R) manner:

Treatment T (Albuterol-HFA, N=200): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment R (Proventil-HFA, N=50): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment P (Placebo-HFA, N=50): two actuations of placebo, QID.

Randomization is achieved with blocks of six (6), with four (4) patients receiving Albuterol-HFA for every one (1) patient receiving Proventil-HFA and every one (1) receiving the Placebo-HFA. At each Clinical Visit that takes place every 3 weeks, the double-blinded (T, P) or evaluator-blinded (R) study drugs will be distributed in resealable masking pouches to the subjects of each arm.

An additional aim of the study is to evaluate the effect of weekly cleaning on the Albuterol-HFA MDI device clinical performance throughout the four, 3-week life-of-device treatment cycles, in conformance with the FDA's specific requirements.

Arms:

All subjects will be screened for enrollment, and will be randomized into the following three treatment groups in a double-blinded (for Treatments T and P) or evaluator-blinded (for Treatment R) manner:

Treatment T (Albuterol-HFA, N=200): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment R (Proventil-HFA, N=50): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment P (Placebo-HFA, N=50): two actuations of placebo, QID.

Eligibility

Minimum age: 12 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female asthma patients aged 12 - 75 years, in general good health.

- A documented history of mild to moderate asthma, for at-least 6-months prior to

Screening, requiring inhaled B2-adrenergic agonists, with or without orally inhaled corticosteroids, for asthma treatment.

- Satisfying criteria of asthma stability, defined as no asthma-related hospitalization

or emergency visits, and no significant changes in asthma therapy, over 4 weeks prior to Screening (with exception for switching from long- to short-acting B2-agonists).

- Can tolerate withholding treatment with inhaled bronchodilators and other allowed

medications for the minimum washout periods indicated in Appendix II prior to the Screening Baseline FEV1 testing.

- Having a Screening Baseline FEV1 test that falls within 50-90% of the predicted

values.

- Airway Reversibility PFT at screening should demonstrate a greater than 12% increase

in FEV1 at 30 minutes of inhaling 2 actuations of Ventolin-HFA (180 mcg albuterol base).

- Demonstrating satisfactory techniques in the use of metered-dose inhaler (MDIs) and a

hand held peak flow meter.

- Female patients of child-bearing potential being non-pregnant and non-lactating at

Screening and throughout the study, and using an acceptable method of contraception during the study.

- Has properly consented to participate in this study.

Exclusion Criteria:

- Male and female asthma patients aged 12 - 75 years, in general good health.

- A documented history of mild to moderate asthma, for at-least 6-months prior to

Screening, requiring inhaled B2-adrenergic agonists, with or without orally inhaled corticosteroids, for asthma treatment.

- Satisfying criteria of asthma stability, defined as no asthma-related hospitalization

or emergency visits, and no significant changes in asthma therapy, over 4 weeks prior to Screening (with exception for switching from long- to short-acting B2-agonists).

- Can tolerate withholding treatment with inhaled bronchodilators and other allowed

medications for the minimum washout periods indicated in Appendix II prior to the Screening Baseline FEV1 testing.

- Having a Screening Baseline FEV1 test that falls within 50-90% of the predicted

values.

- Airway Reversibility PFT at screening should demonstrate a greater than12% increase in

FEV1 at 30 minutes of inhaling 2 actuations of Ventolin-HFA (180 mcg albuterol base).

- Demonstrating satisfactory techniques in the use of metered-dose inhaler (MDIs) and a

hand held peak flow meter.

- Female patients of child-bearing potential being non-pregnant and non-lactating at

Screening and throughout the study, and using an acceptable method of contraception during the study.

- Has properly consented to participate in this study.

Locations and Contacts

Pulmonary Associates of Mobile, PC, Mobile, Alabama 36608, United States

Bensch Research Associates, Stockton, California 95207, United States

Southern California Research, Mission Viejo, California 92691, United States

Clinical Trials of Orange County, Orange, California 92868, United States

CHOC PSF, AMC, Divison AA and I, Orange, California 92868, United States

Allergy Asthma & Respiratory Care Medical Center, Long Beach, California 90806, United States

Allergy & Asthma Specialists Medical Group, Huntington Beach, California 92647, United States

Allergy & Asthma Associates of Santa Clara Valley Research Centere, San Jose, California 95117, United States

Allergy & Asthma Care Center, Long Beach, California 90808, United States

Allergy Associates Medical Group, San Diego, California 92120, United States

Peninsula Research Associates, Rolling Hills Estates, California 90274, United States

Rocky Mountain center for Clinical Research, Wheatridge, Colorado 80033, United States

Colorado Allergy and Asthma Centers, Lakewood, Colorado 80401, United States

Colorado Allergy and Asthma Centers, Denver, Colorado 80230, United States

Waterbury Pulmonary Research, Waterbury, Connecticut 06708, United States

Brandon-Valrico Center for Allergy and Astham Research,LLC, Valrico, Florida 33594, United States

Allergy and Asthma Care of Florida, Ocala, Florida 34471, United States

Atlanta Allergy and Asthma Clinic, Woodstock, Georgia 30188, United States

Family Allergy and Asthma Research Institute, Louisville, Kentucky 40215, United States

Northeast Medical Research Group, N. Dartmouth, Massachusetts 02747, United States

Park Nicollet Institute, Minneapolis, Minnesota 55416, United States

MEDEX Healthcare Research, Inc., St. Louis, Missouri 63117, United States

The Clinical Research Center, LLC, St. Louis, Missouri 63141, United States

Clinical Research Group of Montana, Bozeman, Montana 59718, United States

Montant Medical Research, Missoula, Montana 59808, United States

Astham and Allergy Center, PC, Papillion, Nebraska 68046, United States

New Horizons Clinical Research, Cincinnati, Ohio 45242, United States

Toledo Center for Clinical Research, Sylvania, Ohio 43560, United States

Allergy Asthma and Dermatology Research, Lake Oswego, Oregon 97035, United States

Integrated Medical Research, Ashland, Oregon 97520, United States

Allergy & Asthma Research Group, Eugene, Oregon 97504, United States

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

Allergy Associates Research Center, Portland, Oregon 97213, United States

Allergy and Clinical Immunology Associates, Pittsburgh, Pennsylvania 15241, United States

Pharmaceutical Research & Consulting, Inc., Dallas, Texas 25231, United States

Biogenics Research Institute, San Antonio, Texas 78229, United States

Allergy and Asthma Associates of Houston, Houston, Texas 77054, United States

Clinical Trials of North Houston, Houston, Texas 77070, United States

Kerrville Allergy and Asthma Associates, Kerrville, Texas 78028, United States

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

Virginia Adult and Pediatric Allergy and Asthma, PC, Richmond, Virginia 23229, United States

Astham, Inc., Seattle, Washington 98105, United States

Additional Information

Starting date: September 2007
Last updated: March 12, 2008

Page last updated: June 20, 2008

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