AsthmaPhase 2NCT01252758
Dose Finding Study of Albuterol Sulfate in Patients With Intermittent or Persistent Mild Asthma
A Phase 2 study testing albuterol sufate DPI (TBS-7) dose 1, albuterol sufate DPI (TBS-7) dose 2 and albuterol sufate DPI (TBS-7) dose 3 in people with Asthma, run by Acerus Pharmaceuticals Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- albuterol sufate DPI (TBS-7) dose 1, albuterol sufate DPI (TBS-7) dose 2 and albuterol sufate DPI (TBS-7) dose 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 23Show fewer
- 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
- current or past history of glaucoma
- Clinically significant ECG abnormalities.
- History of seasonal allergic rhinitis that would require treatment during the study period.
- 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.
- Laboratory value exceeding the limit of normal and determined to be clinically relevant by the Investigator.
- Use of concomitant medications which might interfere with participation in the study or the interpretation of data.
- Current smokers.
- Known or suspected history of alcohol drug or drug/solvent abuse
About this study
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
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.
- Conditions
- Asthma
- Being tested
- albuterol sufate DPI (TBS-7) dose 1, albuterol sufate DPI (TBS-7) dose 2, albuterol sufate DPI (TBS-7) dose 3, Placebo, Albuterol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albuterol sufate DPI (TBS-7) dose 1Drug
albuterol sufate DPI (TBS-7) dose 2Drug
albuterol sufate DPI (TBS-7) dose 3Drug
PlaceboOther
AlbuterolDrug
AlbuterolDrug
| Study group | Role | What they receive |
|---|---|---|
| albuterol sufate DPI (TBS-7) dose 1 | Experimental | Not described Receives: Drug: albuterol sufate DPI (TBS-7) dose 1 |
| albuterol sufate DPI (TBS-7) dose 2 | Experimental | Not described Receives: Drug: albuterol sufate DPI (TBS-7) dose 2 |
| albuterol sufate DPI (TBS-7) dose 3 | Experimental | Not described Receives: Drug: albuterol sufate DPI (TBS-7) dose 3 |
| placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Ventolin HFA dose 1 | Active comparator | Not described Receives: Drug: Albuterol |
| Ventolin HFA dose 2 | Active comparator | Not described Receives: Drug: Albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced expiratory volume at one second
Measured: 6 hours
Secondary outcomes (2)
PK parameters
Measured: 6 hours
safety and tolerability
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startNov 2012
- Primary completionApr 2013 (estimated)
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerus Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252758
- Sponsor's protocol ID
- TBS-7-2010-01
- Status last verified
- Mar 2018
- First submitted
- 1 Dec 2010
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01252758
- Acronym / sponsor ID
- TBS-7-2010-01
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Acerus Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| albuterol sufate DPI (TBS-7) dose 1 | Experimental | Drug: albuterol sufate DPI (TBS-7) dose 1 |
| albuterol sufate DPI (TBS-7) dose 2 | Experimental | Drug: albuterol sufate DPI (TBS-7) dose 2 |
| albuterol sufate DPI (TBS-7) dose 3 | Experimental | Drug: albuterol sufate DPI (TBS-7) dose 3 |
| placebo | Placebo comparator | Other: Placebo |
| Ventolin HFA dose 1 | Active comparator | Drug: Albuterol |
| Ventolin HFA dose 2 | Active comparator | Drug: Albuterol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| albuterol sufate DPI (TBS-7) dose 1 | Drug | albuterol sufate DPI (TBS-7) dose 1 |
| albuterol sufate DPI (TBS-7) dose 2 | Drug | albuterol sufate DPI (TBS-7) dose 2 |
| albuterol sufate DPI (TBS-7) dose 3 | Drug | albuterol sufate DPI (TBS-7) dose 3 |
| Placebo | Other | placebo |
| Albuterol | Drug | Ventolin HFA dose 1 |
| Albuterol | Drug | Ventolin HFA dose 2 |
Primary outcome
forced expiratory volume at one second
Time frame: 6 hours
2 secondary outcomes
PK parameters
Time frame: 6 hours
safety and tolerability
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing albuterol sufate DPI (TBS-7) dose 1, albuterol sufate DPI (TBS-7) dose 2 and albuterol sufate DPI (TBS-7) dose 3 in people with Asthma, run by Acerus Pharmaceuticals Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forced expiratory volume at one second (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.