DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Safety Study of Albuterol Spiromax® in Subjects With Asthma

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Placebo MDPI (Drug); Albuterol MDPI (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Teva Pharmaceutical Industries

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.

Clinical Details

Official title: A Multi-Center 52-Week Study to Assess the Safety of Albuterol Spiromax in Subjects With Asthma

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

Primary outcome:

Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)

Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)

Electrocardiogram (ECG) Results At Weeks 0, 12, and 52

Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52

Change From Baseline in Pulse Measurements to Week 12 and Week 52

Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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

Additional Information

Starting date: October 2012
Last updated: August 12, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017