AsthmaPhase 2NCT01174732
Dose-Ranging Study of A006 DPI, in Adult Asthma Patients
A Phase 2 study testing albuterol inhalation powder and albuterol inhalation aerosol in people with Asthma and Bronchospasm, run by Amphastar Pharmaceuticals, Inc. at 4 sites in United States.
Trial summary
This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover and dose-ranging design. This study aims to evaluate the efficacy and initial safety profiles, and to identify the optimum dose of A006, from a select dose-range for future clinical PK/PD and Phase III studies. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma, Bronchospasm
- What is being tested?
- albuterol inhalation powder and albuterol inhalation aerosol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2010to Jan 2011
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- With mild-to-moderate persistent asthma for at least 6 months and having used inhaled beta-agonist for asthma control;
- Must demonstrate response to beta 2 agonist by Reversing;
- Must demonstrate ability to use DPI;
- Females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
- Additional Criteria
Who cannot join
- Smoking history of ≥ 10 pack-years, or having smoked within 6 months;
- Upper respiratory tract infections
- Asthma exacerbations;
- Known intolerance or hypersensitivity to any of the ingredients of the study drug or Proventil®;
- Use of prohibited drugs or failure to observe the drug washout restrictions;
- Having been on other clinical drug/device studies in the last 30 days;
- Other Criteria
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Amphastar Site 0007
Centennial, Colorado, 80112
Amphastar Site 0008
Denver, Colorado, 80230
Amphastar Site 0039
Lakewood, Colorado, 80401
Amphastar Site 0001
San Jose, California, 95117
About this study
Official title: Phase II Study Randomized, Double- or Evaluator-blind, Active- and Placebo-controlled, Single Dose, Seven-arm, Cross-over and Dose-ranging Study of A006 DPI, Albuterol Inhalation Powder, in Adult Asthma Patients
This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover and dose-ranging design. This study aims to evaluate the efficacy and initial safety profiles, and to identify the optimum dose of A006, from a select dose-range for future clinical PK/PD and Phase III studies. This study is to be conducted in generally healthy, adult subjects who have mild-to-moderate persistent asthma for at least 6 months prior to Screening.
- Conditions
- Asthma, Bronchospasm
- Being tested
- albuterol inhalation powder, Placebo, albuterol inhalation aerosol
- Keywords
- asthma, bronchospasm, COPD, chronic respiratory disease
- Medical subject headings
- Asthma, Bronchial Spasm, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albuterol inhalation powderDrug
A006 albuterol inhalation powder, 120 mcg/inhalation, one inhalation
albuterol inhalation powderDrug
A006 albuterol inhalation powder, 180 mcg/inhalation, 1 inhalation
albuterol inhalation powderDrug
A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations
albuterol inhalation powderDrug
A006 albuterol inhalation powder, 180 mcg/inhalation, 2 inhalations
PlaceboDrug
placebo, lactose inhalation carrier
albuterol inhalation aerosolDrug
Also called Proventil
albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations
albuterol inhalation aerosolDrug
Also called Proventil
albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations
| Study group | Role | What they receive |
|---|---|---|
| T1 | Experimental | A006 albuterol inhalation powder, 120 mcg/inhalation, 1 inhalation Receives: Drug: albuterol inhalation powder |
| T2 | Experimental | A006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation Receives: Drug: albuterol inhalation powder |
| T3 | Experimental | A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations Receives: Drug: albuterol inhalation powder |
| T4 | Experimental | A006 albuterol inhalation powder 180 mcg/inhalation, 2 inhalations Receives: Drug: albuterol inhalation powder |
| P | Placebo comparator | Placebo, 2 inhalations Receives: Drug: Placebo |
| R1 | Active comparator | Proventil 90 mcg/inhalation, 2 inhalations Receives: Drug: albuterol inhalation aerosol |
| R2 | Active comparator | Proventil 90 mcg/inhalation, 4 inhalations Receives: Drug: albuterol inhalation aerosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area under the curve (AUC) of post-dose FEV1 percentage changes from the Pre-dose Baseline. The primary analysis of the primary endpoint is to compare the AUC0-t of FEV1, between the A006 treatments and the Placebo Control.
Measured: 5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose.
Secondary outcomes (8)
Time to Effect
Time to onset of bronchodilator effect
Measured: 0 to 360 minutes
Peak Response
peak bronchodilator response
Measured: 0 - 360 minutes
Duration
Duration of effect
Measured: 0 - 360 minutes
Response Rate
Bronchodilatory Response Rate
Measured: 0 - 360 minutes
Hand Tremor
Evaluation of hand tremor
Measured: within 5 min. prior to dosing and 50 and 360 min post-dose.
Vital Signs
Pulse, heartrate, respirations, blood pressure
Measured: within 15 min. prior to dosing, and 30, 90 and 360 min post-dose.
12 lead ECG
12-lead ECG for routine and QT/QTc evaluations
Measured: within 15 min. prior to dosing and at 50 and 360 min postdose.
Blood Work
Collect blood samples (~5 mL) for serum glucose and K+ tests
Measured: within 15 min. prior to dosing, and 30 and 120 min. postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2010
- Study completionJan 2011
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amphastar Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Safety Monitor, Study director, Amphastar Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174732
- Sponsor's protocol ID
- API-A006-CL-B
- Status last verified
- Apr 2017
- First submitted
- 29 Jul 2010
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Randomized, Double- or Evaluator-blind, Active- and Placebo-controlled, Single Dose, Seven-arm, Cross-over and Dose-ranging Study of A006 DPI, Albuterol Inhalation Powder, in Adult Asthma Patients
- ClinicalTrials.gov ID
- NCT01174732
- Acronym / sponsor ID
- API-A006-CL-B
- Conditions
- Asthma, Bronchospasm
- Keywords
- asthma, bronchospasm, COPD, chronic respiratory disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Amphastar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 4 Aug 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.
This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover and dose-ranging design. This study aims to evaluate the efficacy and initial safety profiles, and to identify the optimum dose of A006, from a select dose-range for future clinical PK/PD and Phase III studies. This study is to be conducted in generally healthy, adult subjects who have mild-to-moderate persistent asthma for at least 6 months prior to Screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| T1 | Experimental | Drug: albuterol inhalation powderA006 albuterol inhalation powder, 120 mcg/inhalation, 1 inhalation |
| T2 | Experimental | Drug: albuterol inhalation powderA006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation |
| T3 | Experimental | Drug: albuterol inhalation powderA006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations |
| T4 | Experimental | Drug: albuterol inhalation powderA006 albuterol inhalation powder 180 mcg/inhalation, 2 inhalations |
| P | Placebo comparator | Drug: PlaceboPlacebo, 2 inhalations |
| R1 | Active comparator | Drug: albuterol inhalation aerosolProventil 90 mcg/inhalation, 2 inhalations |
| R2 | Active comparator | Drug: albuterol inhalation aerosolProventil 90 mcg/inhalation, 4 inhalations |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- With mild-to-moderate persistent asthma for at least 6 months and having used inhaled beta-agonist for asthma control;
- Must demonstrate response to beta 2 agonist by Reversing;
- Must demonstrate ability to use DPI;
- Females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
- Additional Criteria
Key exclusion criteria (7 listed)
- Smoking history of ≥ 10 pack-years, or having smoked within 6 months;
- Upper respiratory tract infections
- Asthma exacerbations;
- Known intolerance or hypersensitivity to any of the ingredients of the study drug or Proventil®;
- Use of prohibited drugs or failure to observe the drug washout restrictions;
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 inhalation powderA006 albuterol inhalation powder, 120 mcg/inhalation, one inhalation | Drug | T1 |
| albuterol inhalation powderA006 albuterol inhalation powder, 180 mcg/inhalation, 1 inhalation | Drug | T2 |
| albuterol inhalation powderA006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations | Drug | T3 |
| albuterol inhalation powderA006 albuterol inhalation powder, 180 mcg/inhalation, 2 inhalations | Drug | T4 |
| Placeboplacebo, lactose inhalation carrier | Drug | P |
| albuterol inhalation aerosolAlso: Proventilalbuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations | Drug | R1 |
| albuterol inhalation aerosolAlso: Proventilalbuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations | Drug | R2 |
Primary outcome
AUC
Time frame: 5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose.
Area under the curve (AUC) of post-dose FEV1 percentage changes from the Pre-dose Baseline. The primary analysis of the primary endpoint is to compare the AUC0-t of FEV1, between the A006 treatments and the Placebo Control.
8 secondary outcomes
Time to Effect
Time frame: 0 to 360 minutes
Peak Response
Time frame: 0 - 360 minutes
Duration
Time frame: 0 - 360 minutes
Response Rate
Time frame: 0 - 360 minutes
Hand Tremor
Time frame: within 5 min. prior to dosing and 50 and 360 min post-dose.
Vital Signs
Time frame: within 15 min. prior to dosing, and 30, 90 and 360 min post-dose.
12 lead ECG
Time frame: within 15 min. prior to dosing and at 50 and 360 min postdose.
Blood Work
Time frame: within 15 min. prior to dosing, and 30 and 120 min. postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
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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.
Safety Monitor study director
Amphastar Pharmaceuticals, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing albuterol inhalation powder and albuterol inhalation aerosol in people with Asthma and Bronchospasm, run by Amphastar Pharmaceuticals, Inc. at 4 sites in United States.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUC (time frame: 5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose.). 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 19 Apr 2017.