Safety Study of Albuterol Spiromax® in Subjects With Asthma

NCT ID: NCT01698320

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 364 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of this study is to evaluate the safety of Albuterol Spiromax® over 52 weeks during two dosing periods: (1) a 12-week, double-blind, placebo-controlled QID dosing period followed by (2) a 40-week, open-label PRN dosing period, and to evaluate Albuterol Spiromax® device performance through the life of the device during the study.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo MDPI-Albuterol MDPI

During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

Group Type: PLACEBO_COMPARATOR

Placebo MDPI

Intervention Type: DRUG

Placebo MDPI (multi-dose dry powder inhaler) to match the active intervention.

Albuterol MDPI

Intervention Type: DRUG

Albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation.

Albuterol MDPI-Albuterol MDPI

During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.

Group Type: EXPERIMENTAL

Albuterol MDPI

Intervention Type: DRUG

Albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation.

Interventions

Placebo MDPI

Placebo MDPI (multi-dose dry powder inhaler) to match the active intervention.

Intervention Type: DRUG

Albuterol MDPI

Albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation.

Intervention Type: DRUG

Other Intervention Names

placebo; ProAir® RespiClick; Albuterol Spiromax

Eligibility Criteria

Inclusion Criteria

• Written informed consent and HIPAA signed and dated by the subject or written informed assent signed and dated both by the subject and/or parent/caregiver/legal guardian before conducting any study related procedure.
• Males or females with asthma ages 12 years or older at screening.
• Documented history of persistent asthma and current use of an MDI containing any short-acting beta-adrenergic agonist (e.g. albuterol, levalbuterol,) on average of at least once/week over the 4-weeks prior to screening. The asthma diagnosis must be consistent with the diagnosis of asthma as per the National Asthma Education and Prevention Program.
• If female, is currently not pregnant, breast feeding, or attempting to become pregnant (for 4 weeks before the screening visit and throughout the duration of the study), and is of Non-childbearing potential, defined as:

• ≥1 year post-menopausal or
• Surgically sterile (tubal ligation, bilateral oophorectomy, salpingectomy, or hysterectomy) or is of
• Childbearing potential, has a negative serum pregnancy test, and is willing to commit to using a consistent and acceptable method of birth control
• General good health in the opinion of the investigator as indicated by medical history, physical examination, laboratory tests (hematology, serum chemistry and urinalysis) assessed as either normal or abnormal not clinically significant (NCS) per the principal investigator, as well as a 12-lead ECG interpreted as either "Normal" or "Abnormal NCS" as determined by the central cardiologist. Subjects must also be free of any clinically significant, uncontrolled concomitant conditions other than asthma that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the trial.
• Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, and being compliant with all study requirements (visits, record-keeping, etc).
• Non-smoker for at least one year prior to the screening visit and a maximum pack-year (PY) smoking history of 10 years.
• Able to demonstrate proper inhaler technique with study inhaler.

Exclusion Criteria

• Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject's last study related visit.
• Participation in any investigational drug trial within 30 days preceding the screening visit or planned participation in another investigational drug trial at any time during this trial.
• A known hypersensitivity to albuterol or any of the excipients in the formulations.
• History of severe milk protein allergy
• History of an upper or lower respiratory tract infection or disorder (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza, etc) which is not resolved at least 1 week prior to the SV.
• History of alcohol or drug abuse within two years preceding the SV.
• Use of any protocol prohibited concomitant medications for asthma (any oral β2-adrenergic agonists) or any protocol prohibited concomitant non-asthma medications including treatment with β2-adrenergic receptor antagonists and non-selective β-receptor blocking agents such as β-blocking anti-hypertensive products (administered by any route), MAO inhibitors, and/or tricyclic antidepressants. (Subject's own MDI short-acting β-agonist rescue inhaler should be used until the start of the Run-In period when a study rescue inhaler is provided.)
• Inability or unwillingness to comply with the protocol requirements.
• History of life-threatening asthma [defined here as an asthma episode requiring intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures.]
• Any asthma exacerbation within 3 months of the SV requiring oral or systemic corticosteroids or any hospitalization for asthma within 6 months of the SV.

Note: An exacerbation of asthma is defined as any worsening of asthma requiring any treatment other than rescue albuterol or the subject's regular asthma maintenance therapy. This includes requiring the use of systemic corticosteroids and/or emergency room visit or hospitalization or a change in subject's regular asthma maintenance treatment. A subject does not need to be withdrawn from the study due to an asthma exacerbation unless hospitalization is required or unless the principal investigator believes it is in the subjects' best interest to withdraw from the study.

• Previous participation in an inhaled Albuterol Spiromax® (Teva) study, with the exception of the ABS-AS-306 study.
• Study participation by clinical investigator site employees and/or their immediate relatives.
• Study participation by related or non-related individuals living in the same household, i.e. only one subject per household may participate in the study.
• Any clinically significant endocrine, hematological, hepatic, renal, gastrointestinal, neurological, cardiac, metabolic, immunological, any non-asthmatic acute or chronic pulmonary condition (including but not limited to bronchitis, emphysema, active tuberculosis, bronchiectasis, cystic fibrosis), and malignancy other than basal cell carcinoma. Significant is defined for this protocol as any condition that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the safety analyses.
• Any medical or psychological condition that in the investigator's opinion should preclude enrollment.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Teva Investigational Site 10169

Huntington Beach, California, United States

Teva Investigational Site 10157

San Diego, California, United States

Teva Investigational Site 10148

Denver, Colorado, United States

Teva Investigational Site 10159

Denver, Colorado, United States

Teva Investigational Site 10158

Miami, Florida, United States

Teva Investigational Site 10168

Miami, Florida, United States

Teva Investigational Site 10154

Gainesville, Georgia, United States

Teva Investigational Site 10161

Louisville, Kentucky, United States

Teva Investigational Site 10162

Bethesda, Maryland, United States

Teva Investigational Site 10166

Wheaton, Maryland, United States

Teva Investigational Site 10151

Minneapolis, Minnesota, United States

Teva Investigational Site 10142

Plymouth, Minnesota, United States

Teva Investigational Site 10152

St Louis, Missouri, United States

Teva Investigational Site 10146

Bellevue, Nebraska, United States

Teva Investigational Site 10160

Skillman, New Jersey, United States

Teva Investigational Site 10144

Rochester, New York, United States

Teva Investigational Site 10141

High Point, North Carolina, United States

Teva Investigational Site 10153

Raleigh, North Carolina, United States

Teva Investigational Site 10147

Canton, Ohio, United States

Teva Investigational Site 10143

Cincinnati, Ohio, United States

Teva Investigational Site 10167

Sylvania, Ohio, United States

Teva Investigational Site 10150

Eugene, Oregon, United States

Teva Investigational Site 10156

Portland, Oregon, United States

Teva Investigational Site 10155

El Paso, Texas, United States

Teva Investigational Site 10149

New Braunfels, Texas, United States

Teva Investigational Site 10145

San Antonio, Texas, United States

Teva Investigational Site 10170

San Antonio, Texas, United States

Teva Investigational Site 10163

Burke, Virginia, United States

Teva Investigational Site 10165

Seattle, Washington, United States

Teva Investigational Site 10164

Greenfield, Wisconsin, United States

Countries

United States

References

Raphael G, Taveras H, Iverson H, O'Brien C, Miller D. Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma. J Asthma. 2016;53(2):187-93. doi: 10.3109/02770903.2015.1070862. Epub 2015 Sep 15.

Reference Type: DERIVED

PMID: 26369589 (View on PubMed)

Other Identifiers

ABS-AS-307

Identifier Type: -

Identifier Source: org_study_id