Comparison of Two Bronchodilator Inhalers in Adolescents and Adults With Exercise-Induced Asthma

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00085774
First received: June 14, 2004
Last updated: March 19, 2015
Last verified: March 2015
  Purpose

This study was designed to examine the effectiveness of two bronchodilator inhalers in patients who have exercise-induced asthma.


Condition Intervention Phase
Exercise-induced Bronchospasm
Drug: albuterol aerosol by HFA MDI
Drug: albuterol aerosol by HFA BOI
Drug: placebo aerosol by HFA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-Dose Efficacy Comparison of Albuterol Hydrofluoroalkane (HFA) Breath-operated Inhaler (BOI) (Volare Easi-Breathe™) and Albuterol HFA Meter Dose Inhaler (MDI) (Volare™) in Adolescents and Adults With Exercise-Induced Bronchospasm

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • The primary endpoint was mean maximum % change in the baseline absolute forced expiratory volume in 1 second (FEV1) value observed up to 1 hour post-challenge. [ Time Frame: Three doses 2-7 days apart ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean maximum percent change in the baseline percent predicted FEV1 value observed up to one hour post-challenge [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ] [ Designated as safety issue: No ]
  • Mean maximum absolute change in the baseline absolute FEV1 value observed up to one hour post-challenge [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ] [ Designated as safety issue: No ]
  • Mean percent change in the baseline absolute FEV1 value at each post-challenge time point [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ] [ Designated as safety issue: No ]
  • Mean absolute change in the baseline absolute FEV1 value at each post-challenge time point [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ] [ Designated as safety issue: No ]
  • Mean percent change in the baseline percent-predicted FEV1 value at each post-challenge time point [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ] [ Designated as safety issue: No ]
  • Mean largest negative (or mean smallest positive) percent change in the baseline absolute FEV1 value observed up to one hour post-challenge [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ] [ Designated as safety issue: No ]
  • Mean largest negative (or mean smallest positive) percent change in the average test-day pre-dose baseline percent predicted FEV1 value observed up to one hour post-challenge [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ] [ Designated as safety issue: No ]
  • Time to recovery (in minutes) measured from time of completion of exercise challenge to time FEV1 returns to 10% or less of baseline value during the recovery phase [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ] [ Designated as safety issue: No ]
  • Total changes in FEV1 expressed as the baseline-adjusted area-under-the-effect curve of the percent-predicted FEV1 versus time over 60 minutes (AUEC0 60) [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ] [ Designated as safety issue: No ]
  • Percentage of patients who are "protected" (maximum percent decrease in the baseline absolute FEV1 <10%), "partially protected" (10 20%), and "unprotected" (>20%). [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2004
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albuterol HFA BOI Drug: albuterol aerosol by HFA BOI
albuterol HFA BOI 160 mcg
Experimental: Albuterol HFA MDI Drug: albuterol aerosol by HFA MDI
albuterol HFA MDI 160 mcg
Placebo Comparator: Placebo Drug: placebo aerosol by HFA
placebo HFA

  Eligibility

Ages Eligible for Study:   12 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide written informed consent
  • Male or non-pregnant, non-nursing females aged 12 40 years, inclusive, at the first screening visit
  • Have exercise-induced bronchospasm (EIB), with or without asthma, as demonstrated by a ≥15% decrease in pre-challenge absolute FEV1 observed up to 60 minutes following an exercise challenge conducted at the first screening visit
  • Predicted FEV1 ≥70% for age, height, gender, and, where applicable, race following an 8 hour period without [beta]2 agonist use
  • Have no contraindications for exercising maximally
  • Ability to perform spirometry reproducibly (i.e., the difference between the two highest FEV1 values out of a minimum of three and a maximum of eight values obtained at the first screening visit must not exceed 0.2 L)
  • Ability to self-perform PEF (peak expiratory flow) determinations with a handheld peak flow meter
  • Can tolerate withdrawal of applicable medications for qualification at both screening visits
  • Normal chest X ray, or, if abnormal, is consistent with asthma and shows no evidence of other active disease
  • Otherwise healthy individuals with clinically acceptable medical history, physical examination, vital signs, and 12 lead ECG (electrocardiogram; with 30 second Lead II rhythm strip)
  • Body mass index (BMI) of 19 29 kg/m2 (BMI = weight [kg] / height2 [m])
  • Non-smokers for at least one year prior to the first screening visit and have maximum smoking histories of ten-pack years (i.e., equivalent to 20 cigarettes per day for 10 years).

Exclusion Criteria:

  • Allergy or sensitivity to albuterol or to other components of the formulations used in the drug
  • Exposure to investigational drugs within 30 days prior to the first screening visit
  • Require continuous treatment with [beta] blockers (administered by any route), MAO (monoamine oxidase) inhibitors, tricyclic antidepressants, cromones (by any route), antileukotrienes, and/or systemic corticosteroids
  • Treated with oral or injectable corticosteroids within the 12 weeks prior to the first screening visit
  • The prescribed dose regimen of any required inhaled corticosteroids has not been stable for at least four weeks prior to the first screening visit NOTE: Patients requiring subsequent dosage adjustment of these drug products must be discontinued from the study.
  • Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications and xanthine-containing foods and beverages prior to the screening visit
  • Treatment in an emergency room for asthmatic symptoms or hospitalization for asthmatic symptoms within twelve months prior to the first screening visit
  • Experienced an upper respiratory tract infection and/or sinusitis associated with exacerbation of asthmatic symptoms not requiring emergency room treatment and/or hospitalization and/or treatment with oral or injected corticosteroids that has not resolved within four weeks prior to the screening visit
  • History and/or presence of any clinically-significant acute or chronic disease, including but not limited to bronchitis, emphysema, active tuberculosis, bronchiectasis, cystic fibrosis, clinically significant cardiovascular disease (including cardiac arrhythmias and uncontrolled hypertension), clinically significant hepatic, renal, or endocrine dysfunction, stroke, uncontrolled diabetes, hyperthyroidism, convulsive disorders, and neoplastic disease other than basal cell carcinoma of the skin
  • Known or suspected substance abuse (e.g., alcohol, marijuana, etc.) and/or presence of any other medical or psychological conditions that in the investigator's opinion should preclude study enrollment.
  • Are employees of this study site or have a family member associated with the conduct of this study at this site
  • Previous enrollment in an IVAX Research-sponsored Albuterol HFA aerosol asthma study.
  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: NCT00085774

Locations
United States, Colorado
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, United States, 80230
Colorado Allergy and Asthma Centers, PC
Englewood, Colorado, United States, 80112
Colorado Allergy and Asthma Centers, PC
Lakewood, Colorado, United States, 80401
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Principal Investigator: David S Pearlman, MD Colorado Allergy and Asthma Centers, PC
  More Information

No publications provided

Responsible Party: Vice President, Global Respiratory Clincial Research, Teva Global Respiratory Research LLC
ClinicalTrials.gov Identifier: NCT00085774     History of Changes
Other Study ID Numbers: IXR-302-4-167
Study First Received: June 14, 2004
Last Updated: March 19, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
albuterol
aerosol inhaler
metered-dose inhaler
breath-actuated inhaler
exercise-induced bronchospasm

Additional relevant MeSH terms:
Asthma, Exercise-Induced
Bronchial Spasm
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
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 August 30, 2015