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Safety Study of Albuterol Spiromax® in Subjects With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01698320
First received: September 14, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

In the US, inhaled albuterol is currently available for use in an aerosol formulation dispensed by metered dose inhalers (MDI). A common problem with conventional MDI devices is inefficient inhaler technique (i.e., inability to properly coordinate actuation with inspiration). Inefficient inhaler technique can compromise delivery of the active drug to the airways and potentially result in suboptimal clinical benefits. Breath actuation has been found to reduce administration errors in comparison with conventional MDIs.


Condition Intervention Phase
Asthma
Drug: Albuterol Spiromax® 90 mcg/ inhalation
Drug: Placebo Spiromax®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center 52-Week Study to Assess the Safety of Albuterol Spiromax® in Subjects With Asthma

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Safety and Tolerability from Baseline to Week 52 [ Time Frame: Baseline to week 52 ] [ Designated as safety issue: Yes ]
    Planned safety measures include the recording of adverse events throughout the study period, vital signs at all scheduled study visits, as well as physical exams, ECGs, and clinical laboratory assessments at screening and weeks 12 and 52.


Secondary Outcome Measures:
  • Composite Measurement of Device Ruggedness From Baseline to Week 52 [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Device Ruggedness: Reports of any problems/malfunction of the device (e.g., lack of efficacy, problems/malfunction after the device is dropped or sustains physical impact).

  • Device Invitro Evaluations to Week 52 [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]

    Device In Vitro Evaluations - All used study inhalers will be collected and a random selection of inhalers will be tested as follows:

    • Fifty (50) Albuterol Spiromax® inhalers used during weeks 0-12 will be randomly selected for in vitro testing
    • Fifty (50) Albuterol Spiromax® inhalers used during weeks 12-52 will be randomly selected for in vitro testing

  • Daily AM Peak Expiratory Flow (PEF) to Week 52 [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Daily AM PEF will be recorded throughout the duration of the study to provide information on the subject's asthma status in order to assist in distinguishing between the use of back-up rescue medication related to an increased need for asthma symptom relief from that related to an issue with the Albuterol Spiromax® rescue inhaler.


Enrollment: 338
Study Start Date: October 2012
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albuterol Spiromax® 90 mcg/ inhalation

Mode of Administration: orally inhaled dry powder

Doses Weeks 0-12:

Two (2) inhalations (90 mcg/ inhalation) self-administered QID (at approximately 7 AM, 12 Noon, 5 PM, and at bedtime).

Doses Weeks 12-52:

Two (2) inhalations (90 mcg/ inhalation) self-administered), PRN (every 4-6 hours and, if applicable, two (2) inhalations 15-30 minutes prior to sports/exercise for the prevention of exercise induced bronchoconstriction (EIB).

Drug: Albuterol Spiromax® 90 mcg/ inhalation
Placebo Comparator: Placebo Spiromax®

Mode of Administration: orally inhaled dry powder

Doses Weeks 0-12:

Two (2) inhalations self-administered QID (at approximately 7 AM, 12 Noon, 5 PM and at bedtime).

Drug: Placebo Spiromax®

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698320

  Show 30 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01698320     History of Changes
Other Study ID Numbers: ABS-AS-307
Study First Received: September 14, 2012
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Albuterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on November 23, 2014