Dose Finding Study of Albuterol Sulfate in Patients With Intermittent or Persistent Mild Asthma
A Phase II Study to Assess the Efficacy and Safety of a Single Inhaled Dose of Albuterol Sulfate Dry Powder Via the Trivair Deposition System Versus Albuterol Sulfate HFA pMDI in Patients With Intermittent or Persistent Mild Asthma
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The drug product albuterol sulfate DPI, TBS-7, is a single dose inhalation product of albuterol sulfate containing 240 ug albuterol sulphate (200 ug of albuterol) and inhalation grade lactose in a new dry powder delivery system called the Trivair deposition system. Three different doses of albuterol sulfate DPI, TBS-7, will be administered in this dose ranging clinical trial: an optimal dose, 80% of the optimal dose and 50% of the optimal dose and will be compared with placebo and an active comparator.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2012
Longer than P75 for phase_2 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
December 3, 2010
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMarch 13, 2018
March 1, 2018
5 months
December 1, 2010
March 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
forced expiratory volume at one second
6 hours
Secondary Outcomes (2)
PK parameters
6 hours
safety and tolerability
7 days
Study Arms (6)
albuterol sufate DPI (TBS-7) dose 1
EXPERIMENTALalbuterol sufate DPI (TBS-7) dose 2
EXPERIMENTALalbuterol sufate DPI (TBS-7) dose 3
EXPERIMENTALplacebo
PLACEBO COMPARATORVentolin HFA dose 1
ACTIVE COMPARATORVentolin HFA dose 2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Generally healthy male or female subjects, over the age of 18. Females of child bearing potential must be non-pregnant (confirmed by a negative serum hCG test at the screening visit) or non-lactating.
- Documented clinical history (minimum six months) of intermittent or mild persistent asthma according to the Global Initiative for Asthma (GINA, 2009) criteria requiring and responding to short acting inhaled b2-agonist (SABA) therapy.
- Using a SABA alone, or concurrent use of anti-inflammatory therapy, (i.e. Singulair,® theophylline or inhaled corticosteroid (ICS)). The dose and frequency of anti-inflammatory medication should be stable for at least four weeks prior to the screening visit. For subjects who are currently taking an ICS, the total daily dose should not exceed 1000µg budesonide or equivalent steroid.
- A pre-bronchodilator FEV1 ≥ 60% to 90% of predicted at screening.
- Confirmed diagnosis of asthma by demonstrating: Reversibility of airway obstruction of ≥ 12% increase in FEV1 within 30 minutes after the inhalation of a standard dose of albuterol (2 puffs, 180 µg) delivered via pMDI.
- Nonsmokers or ex-smokers (stopped at least 6-month period prior to the screening visit).
You may not qualify if:
- A change in asthma mediation within the previous four weeks of screening visit.
- A life-threatening asthma episode within the last six months or \> 2 within the past year. A life-threatening asthma episode is defined as an asthma exacerbation which required hospitalization and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures.
- If in the Investigator's opinion, the subjects asthma severity is too severe to participate in the study, or they would be unable to withhold their asthma medication for the times outlined above as well as require the use of daily high dose ICS (\>1000µg budesonide or equivalent).
- Use of a long acting inhaled b2-agonist (LABA), ipratropium bromide containing medication (ie. Combivent) or Tiotropium therapy.
- Use of any oral, depot or parental corticosteroids within four weeks of screening visit. The use of topical corticosteroid cream (\<1%) to treat skin conditions is allowed.
- History of an upper or lower respiratory tract infection requiring antibiotics; emergency room treatment in the preceding four weeks; or hospitalization in the previous three months; or a history of multiple hospital visits for treatment of their respiratory disease.
- History of any immediate or delayed hypersensitivity reaction to inhaled b2-agonists, lactose, milk-protein, or excipients (pMDI inhalers) any component of the formulations.
- Clinically significant history or current evidence of any of the diseases listed below. Clinically significant is defined as any diseases that in the opinion of the Investigator would put the subject at risk through study participation. These include, but are not limited to:
- bronchiectasis, bronchopulmonary dysplasia, cystic fibrosis, emphysema, chronic bronchitis, or other significant lung diseases
- hypertension which, in the opinion of the Investigator, deems the subject unfit to enter the study; subjects must not have a persistent systolic pressure above 145 mmHg or diastolic pressure above 85 mmHg unless the Investigator confirms that it is satisfactory for their age.
- arrhythmias, coronary artery disease, congestive heart failure, congenital heart disease or other significant cardiac disease
- diabetes mellitus requiring medication
- cirrhosis, alcoholism, biliary obstruction or other hepatic disease
- epilepsy, psychosis, or other conditions/diseases of the nervous system
- malignancy
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2010
First Posted
December 3, 2010
Study Start
November 1, 2012
Primary Completion
April 1, 2013
Study Completion
October 1, 2015
Last Updated
March 13, 2018
Record last verified: 2018-03