Dose Finding Study of Albuterol Sulfate in Patients With Intermittent or Persistent Mild Asthma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Trimel Biopharma SRL.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Trimel Biopharma SRL
ClinicalTrials.gov Identifier:
NCT01252758
First received: December 1, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: albuterol sufate DPI (TBS-7) dose 1
Drug: albuterol sufate DPI (TBS-7) dose 2
Drug: albuterol sufate DPI (TBS-7) dose 3
Other: Placebo
Drug: Albuterol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Trimel Biopharma SRL:

Primary Outcome Measures:
  • forced expiratory volume at one second [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK parameters [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
  • safety and tolerability [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: March 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: albuterol sufate DPI (TBS-7) dose 1 Drug: albuterol sufate DPI (TBS-7) dose 1
Experimental: albuterol sufate DPI (TBS-7) dose 2 Drug: albuterol sufate DPI (TBS-7) dose 2
Experimental: albuterol sufate DPI (TBS-7) dose 3 Drug: albuterol sufate DPI (TBS-7) dose 3
Placebo Comparator: placebo Other: Placebo
Active Comparator: Ventolin HFA dose 1 Drug: Albuterol
Active Comparator: Ventolin HFA dose 2 Drug: Albuterol

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Jodi Dickstein, Trimel BioPharma
ClinicalTrials.gov Identifier: NCT01252758     History of Changes
Other Study ID Numbers: TBS-7-2010-01
Study First Received: December 1, 2010
Last Updated: December 1, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014