Dose Finding Study of Albuterol Sulfate in Patients With Intermittent or Persistent Mild Asthma
Information source: Trimel Biopharma SRL
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: albuterol sufate DPI (TBS-7) dose 1 (Drug); albuterol sufate DPI (TBS-7) dose 2 (Drug); albuterol sufate DPI (TBS-7) dose 3 (Drug); Placebo (Other); Albuterol (Drug); Albuterol (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Trimel Biopharma SRL
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: forced expiratory volume at one second
Secondary outcome: PK parameterssafety and tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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.
2. 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.
3. 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.
4. A pre-bronchodilator FEV1 ≥ 60% to 90% of predicted at screening.
5. 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.
6. Nonsmokers or ex-smokers (stopped at least 6-month period prior to the screening
visit).
Exclusion Criteria:
1. A change in asthma mediation within the previous four weeks of screening visit.
2. 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 hypercapnea, respiratory arrest,
or hypoxic seizures.
3. If in the Investigator or subinvestigator'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).
4. Use of a long acting inhaled b2-agonist (LABA), ipratropium bromide containing
medication (ie. Combivent) or Tiotropium therapy.
5. 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.
6. 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.
7. History of any immediate or delayed hypersensitivity reaction to inhaled b2-agonists,
lactose, milk-protein, or excipients (pMDI inhalers) any component of the
formulations.
8. 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
- current or past history of glaucoma
9. Clinically significant ECG abnormalities.
10. History of seasonal allergic rhinitis that would require treatment during the study
period.
11. History of immunotherapy within six months of the screening visit or planned
initiation of immunotherapy within the study period. Subjects will be allowed to
enter the study if undergoing de-sensitization to a specific allergen for at least
six months on a stable maintenance dose prior to the screening visit. Seasonal pollen
de-sensitization therapy is allowed if this is not the initial course and no
significant adverse effect was observed with the previous administration.
12. Laboratory value exceeding the limit of normal and determined to be clinically
relevant by the Investigator.
13. Use of concomitant medications which might interfere with participation in the study
or the interpretation of data.
14. Current smokers.
15. Known or suspected history of alcohol drug or drug/solvent abuse
Locations and Contacts
Additional Information
Starting date: March 2011
Last updated: December 1, 2010
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