Single-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced Bronchoconstriction

NCT00634829 | Terminated Phase 3

• 1 other identifier: API-A004-CLN-D
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

This clinical study will evaluate and establish the protective effects of Amphastar's Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA), in preventing exercise-induced bronchoconstriction (EIB) in adolescent and adult asthmatic patients, in comparison with (1) Proventil®-HFA (Reference drug and Active Control ), and (2) Placebo-HFA control (HFA propellant only). Safety of the test drug, Albuterol-HFA, will also be evaluated in comparison to the Active and Placebo Controls. Analyses will be performed to determine if the Armstrong's Albuterol-HFA has resulted in a significant bronchoprotective effect, with attenuated Max % Fall in FEV1, in comparison to the Placebo-HFA control.

Conditions

Asthma; Bronchospasm

Outcome Measures

Primary Outcomes (1)

• The maximum percentage fall in FEV1, from the Pre-Exercise FEV1, between Albuterol-HFA and Placebo-HFA.

  90 minutes post exercise

Secondary Outcomes (11)

• Evaluation of relative broncho-protective efficacy of Albuterol-HFA, in comparison to the active comparator, Proventil®-HFA, using the Max % fall in Post-Exercise FEV1, from the Pre-exercise FEV1

  90 minutes post exercise

• Pre-exercise FEV1 values (volume in Liters, recorded ), indicative of bronchodilator responsiveness.

  20-30 min post dose

• Number and percentage of subjects who demonstrate a <20.0% fall in FEV1, from the Pre-exercise FEV1.

  90 min post-exercise

• Area Under-the-Curve of percentage fall in FEV1, from the Pre-exercise FEV1.

  90 min post-exercise

• Time to recovery, as the time point where FEV1 recovers from maximum percent fall in FEV1 to be within 5.0% of the Pre-Exercise FEV1 values.

  concurrent with study visit

Study Arms (3)

T

EXPERIMENTAL

Armstrong Albuterol HFA Inhalation Aerosol

Drug: albuterol (Armstrong Albuterol HFA)

R

ACTIVE COMPARATOR

2 inhalations Proventil-HFA Albuterol Sulfate, 108 mcg, prior to exercise

Drug: Albuterol Sulfate (Provenetil-HFA)

P

PLACEBO COMPARATOR

Placebo-HFA

Drug: Placebo-HFA

Interventions

albuterol (Armstrong Albuterol HFA) DRUG

2 inhalations of 108 mcg albuterol sulfate prior to exercise, single dose

Also known as: A004, Albuterol-HFA Inhalation Aerosol

T

Albuterol Sulfate (Provenetil-HFA) DRUG

2 inhalations of Proventil-HFA, 108 mcg/inhalation prior to exercise

Also known as: Provenetil-HFA, albuterol sulfate-HFA

R

Placebo-HFA DRUG

Placebo containing HFA propellant without active drug substance

P

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female subjects, aged 12 - 50 years, and in general good health.
• A documented history of mild to moderate asthma, for at-least 6-months, requiring inhaled B-adrenergic agonists for symptom control.
• Having a history of exercise-induced bronchoconstriction, that can be prevented or relieved by the use of an inhaled B-agonist.
• Satisfying asthma stability requirement, such that over the 30 days prior to the screening, there are no significant changes in asthma therapy and no asthma-related hospitalization or emergency medical visits.
• Being able to withhold treatment with inhaled bronchodilators and/or restricted medications for the minimum washout periods indicated in Appendix II prior to pulmonary function testing at Screening Visit and Clinical Visits 1, 2 and 3.
• Having a baseline forced expiratory volume in the 1st second (FEV1) that is greater than nor equal to 65.0% of predicted normal values.
• Demonstrating a greater than or equal to 20.0%, but \<50.0%, fall in FEV1 during a Standard Exercise Challenge test per current ATS guidance, at Screening.
• Demonstrating satisfactory techniques in the correct use of metered-dose inhaler (MDIs).
• Female patients of child-bearing potential being non-pregnant and non-lactating, and using an acceptable method of contraception.
• Willingness and ability to sign the informed consent and HIPPA forms to participate in this trial.

You may not qualify if:

• A smoking history of ≥10 pack-years, or having smoked within the past 12 months prior to Screening.
• Any current or past significant respiratory diseases that might significantly interfere with pharmacodynamic response to the study drugs, such as cystic fibrosis, bronchiectasis, emphysema, pulmonary malignancies, etc, other than asthma.
• Clinically significant cardiovascular, hematological, renal, neurologic, hepatic, and endocrine disorders, or psychiatric diseases, or any other significant health conditions that in the opinion of the investigator might interfere with bronchodilator responses.
• Recent upper or lower respiratory tract infection (within 4 weeks) prior to Screening.
• Recent (per Appendix II, Part I) use of orally ingested or systemically administered corticosteroids, B-adrenergic bronchodilators, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), B-blockers, or drugs that affect study drug performance.
• Taking \>1,000 mcg daily of inhaled beclomethasone dipropionate or budesonide, or \>500 mcg daily of inhaled fluticasone propionate, or taking high doses of other orally inhaled corticosteroids that suggest severe asthma state, in the opinion of the investigator, within four weeks of Screening.
• Demonstrating clinically significant abnormal 12-lead ECG results, upon Screening.
• Any significant physical (e.g., musculoskeletal, overweight, etc) conditions that, in the opinion of the investigator, could limit the subject's ability to perform the exercise challenge test.
• Known intolerance or hypersensitivity to any component of the MDI formulation (albuterol, HFA-134a, oleic acid and alcohol).
• Known or reasonably suspected substance abuses.

Sponsors & Collaborators

• Amphastar Pharmaceuticals, Inc.: lead

Study Sites (3)

Colorado Allergy and Asthma Center

Denver, Colorado, 80230, United States

Location

Colorado Allergy and Asthma Center

Englewood, Colorado, 80112, United States

Location

Colorado Allergy and Asthma Center

Lakewood, Colorado, 80401, United States

Location

MeSH Terms

Conditions

Asthma; Bronchial Spasm

Interventions

Albuterol; RNA aptamer SUP-A-004

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 13, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

US (3)