AsthmaPhase 2A006-DNCT02271334
Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers
A Phase 2 study testing A006 DPI and Proventil® MDI in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The objective of this study is to evaluate the pharmacokinetics (PK) and safety profiles of A006, an Albuterol dry powder inhaler (DPI), following a single dose of 110 mcg (T1) or 220 mcg (T2), in healthy male and female adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- A006 DPI and Proventil® MDI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Mar 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy, male and female adults, 18-40 years of age at Screening;
- Having no clinically significant respiratory, cardiovascular and other systemic or organic illnesses;
- Body weight ≥ 50 kg for men and ≥ 45 kg for women, and BMI within the range of 18.5 - 30.0 kg/m2 inclusive;
- Sitting blood pressure ≤ 135/90 mmHg;
- Demonstrating negative HIV, HBsAg and HCV tests, alcohol and nine panel urine drug screen tests;
- Demonstrating proficiency in the use of DPI and MDI or able to be trained in the proper use of these devices;
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- Demonstrating Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training), for at least 2 times consecutively, with a maximum of 5 attempts;
- Having no known hypersensitivity to any ingredients of A006 and Proventil® MDI (Albuterol, sulfate, lactose, milk protein, HFA-134a, oleic acid, or ethanol). (Subjects must be able to tolerate at least one teaspoon of milk);
- Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control; and
- Having properly consented and satisfied all other inclusion/exclusion criteria as required for this protocol.
Who cannot join
- A smoking history of ≥ 5 pack-years, or having smoked within 6 months prior to Screening;
- Upper respiratory tract infections within 2 weeks, or lower respiratory tract infection within 4 weeks, prior to Screening;
- Previous history of asthma or COPD;
- Any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases;
- Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant, or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study;
- ECG at Screening and Visit-1 baseline expressed any single or multiple premature ventricular contractions (PVC);
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- ECG at Screening and Visit-1 baseline with a QTc reading greater than 450ms;
- Use of prohibited drugs or failure to observe the drug washout restrictions; and
- Having been on other clinical drug/device studies or donated blood in the last 30 days prior to Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers (A Randomized, Double- or Evaluator-blinded, Single-dose, Four-arm, Crossover Pharmacokinetics (PK) Study in Healthy Adults)
The objective of this study is to evaluate the pharmacokinetics (PK) and safety profiles of A006, an Albuterol dry powder inhaler (DPI), following a single dose of 110 mcg (T1) or 220 mcg (T2), in healthy male and female adult volunteers.
Read the detailed description
This study is a randomized, double or evaluator-blinded, single dose, four-arm, crossover PK study in eighteen (18) healthy volunteers, both male and female adults, at 18-40 years of age.
All candidates will be screened and only those who satisfy all enrollment criteria will be enrolled into this study. Each study subject will participate in a screening visit and four (4) study visits with one (1) randomized study treatment given in each visit.
PK samples will be analyzed with an established LC/MS/MS method. An End-of-Study (EOS) safety evaluation will be conducted at the end of Study Visit-4.
- Conditions
- Asthma
- Being tested
- A006 DPI, Proventil® MDI
- Keywords
- Asthma, Albuterol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A006 DPIDrug
Also called Albuterol, Albuterol DPI
Single dose 110 mcg, 1 inhalation
A006 DPIDrug
Also called Albuterol, Albuterol DPI
Single dose 220 mcg, 1 inhalation
Proventil® MDIDrug
Also called Proventil®
Single dose 90 mcg, 1 inhalation
Proventil® MDIDrug
Also called Proventil®
Single dose 90 mcg, 2 inhalations
| Study group | Role | What they receive |
|---|---|---|
| Treatment T1 | Experimental | One inhalation of 110 mcg A006 DPI. Total 110 mcg Receives: Drug: A006 DPI |
| Treatment T2 | Experimental | One inhalation of 220 mcg A006 DPI. Total 220 mcg. Receives: Drug: A006 DPI |
| Treatment R1 | Active comparator | One inhalation of 90 mcg Proventil® MDI. Total 90 mcg. Receives: Drug: Proventil® MDI |
| Treatment R2 | Active comparator | Two inhalations of 90 mcg Proventil® MDI. Total 180 mcg Receives: Drug: Proventil® MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve of Drug Concentration versus Time (AUC[0-t])
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Area under the curve of the drug concentration versus time curve (AUC[0-t]) for each treatment period will be calculated using the trapezoidal rule.
Measured: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
Peak Plasma Concentration (C[max])
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Peak plasma concentration (C[max]) will be the highest concentration of Albuterol during each treatment period.
Measured: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
Time to Reach Peak Plasma Concentration (t[max])
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Time to reach peak plasma concentration (t[max]) will be the time it takes to reach the highest concentration of Albuterol during each treatment period.
Measured: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
Plasma Albuterol Concentrations at All Time Points
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Plasma Albuterol concentrations at these time points will be reported during each treatment period.
Measured: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 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 Pharmeceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271334
- Sponsor's protocol ID
- API-A006-CL-D
- Acronym
- A006-D
- Status last verified
- Apr 2017
- First submitted
- 20 Oct 2014
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lipworth BJ, Clark DJ. Lung delivery of salbutamol given by breath activated pressurized aerosol and dry powder inhaler devices. Pulm Pharmacol Ther. 1997 Aug;10(4):211-4. doi: 10.1006/pupt.1997.0093.
PubMed 9695144Ahrens RC. The role of the MDI and DPI in pediatric patients: "Children are not just miniature adults". Respir Care. 2005 Oct;50(10):1323-8; discussion 1328-30.
PubMed 16185368Goldstein DA, Tan YK, Soldin SJ. Pharmacokinetics and absolute bioavailability of salbutamol in healthy adult volunteers. Eur J Clin Pharmacol. 1987;32(6):631-4. doi: 10.1007/BF02456001.
PubMed 3653233Hindle M, Newton DA, Chrystyn H. Dry powder inhalers are bioequivalent to metered-dose inhalers. A study using a new urinary albuterol (salbutamol) assay technique. Chest. 1995 Mar;107(3):629-33. doi: 10.1378/chest.107.3.629.
PubMed 7874928
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
- Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers (A Randomized, Double- or Evaluator-blinded, Single-dose, Four-arm, Crossover Pharmacokinetics (PK) Study in Healthy Adults)
- ClinicalTrials.gov ID
- NCT02271334
- Acronym / sponsor ID
- A006-D / API-A006-CL-D
- Conditions
- Asthma
- Keywords
- Asthma, Albuterol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Amphastar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Oct 2014 (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 objective of this study is to evaluate the pharmacokinetics (PK) and safety profiles of A006, an Albuterol dry powder inhaler (DPI), following a single dose of 110 mcg (T1) or 220 mcg (T2), in healthy male and female adult volunteers.
Detailed description
This study is a randomized, double or evaluator-blinded, single dose, four-arm, crossover PK study in eighteen (18) healthy volunteers, both male and female adults, at 18-40 years of age.
All candidates will be screened and only those who satisfy all enrollment criteria will be enrolled into this study. Each study subject will participate in a screening visit and four (4) study visits with one (1) randomized study treatment given in each visit.
PK samples will be analyzed with an established LC/MS/MS method. An End-of-Study (EOS) safety evaluation will be conducted at the end of Study Visit-4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment T1 | Experimental | Drug: A006 DPIOne inhalation of 110 mcg A006 DPI. Total 110 mcg |
| Treatment T2 | Experimental | Drug: A006 DPIOne inhalation of 220 mcg A006 DPI. Total 220 mcg. |
| Treatment R1 | Active comparator | Drug: Proventil® MDIOne inhalation of 90 mcg Proventil® MDI. Total 90 mcg. |
| Treatment R2 | Active comparator | Drug: Proventil® MDITwo inhalations of 90 mcg Proventil® MDI. Total 180 mcg |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Generally healthy, male and female adults, 18-40 years of age at Screening;
- Having no clinically significant respiratory, cardiovascular and other systemic or organic illnesses;
- Body weight ≥ 50 kg for men and ≥ 45 kg for women, and BMI within the range of 18.5 - 30.0 kg/m2 inclusive;
- Sitting blood pressure ≤ 135/90 mmHg;
- Demonstrating negative HIV, HBsAg and HCV tests, alcohol and nine panel urine drug screen tests;
Key exclusion criteria (9 listed)
- A smoking history of ≥ 5 pack-years, or having smoked within 6 months prior to Screening;
- Upper respiratory tract infections within 2 weeks, or lower respiratory tract infection within 4 weeks, prior to Screening;
- Previous history of asthma or COPD;
- Any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases;
- Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant, or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study;
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 |
|---|---|---|
| A006 DPIAlso: Albuterol, Albuterol DPISingle dose 110 mcg, 1 inhalation | Drug | Treatment T1 |
| A006 DPIAlso: Albuterol, Albuterol DPISingle dose 220 mcg, 1 inhalation | Drug | Treatment T2 |
| Proventil® MDIAlso: Proventil®Single dose 90 mcg, 1 inhalation | Drug | Treatment R1 |
| Proventil® MDIAlso: Proventil®Single dose 90 mcg, 2 inhalations | Drug | Treatment R2 |
Primary outcome
Area Under the Curve of Drug Concentration versus Time (AUC[0-t])
Time frame: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Area under the curve of the drug concentration versus time curve (AUC[0-t]) for each treatment period will be calculated using the trapezoidal rule.
Peak Plasma Concentration (C[max])
Time frame: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Peak plasma concentration (C[max]) will be the highest concentration of Albuterol during each treatment period.
Time to Reach Peak Plasma Concentration (t[max])
Time frame: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Time to reach peak plasma concentration (t[max]) will be the time it takes to reach the highest concentration of Albuterol during each treatment period.
Plasma Albuterol Concentrations at All Time Points
Time frame: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Plasma Albuterol concentrations at these time points will be reported during each treatment period.
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.
- Background: PubMed 9695144Lipworth BJ, Clark DJ. Lung delivery of salbutamol given by breath activated pressurized aerosol and dry powder inhaler devices. Pulm Pharmacol Ther. 1997 Aug;10(4):211-4. doi: 10.1006/pupt.1997.0093.
- Background: PubMed 16185368Ahrens RC. The role of the MDI and DPI in pediatric patients: "Children are not just miniature adults". Respir Care. 2005 Oct;50(10):1323-8; discussion 1328-30.
- Background: PubMed 3653233Goldstein DA, Tan YK, Soldin SJ. Pharmacokinetics and absolute bioavailability of salbutamol in healthy adult volunteers. Eur J Clin Pharmacol. 1987;32(6):631-4. doi: 10.1007/BF02456001.
- Background: PubMed 7874928Hindle M, Newton DA, Chrystyn H. Dry powder inhalers are bioequivalent to metered-dose inhalers. A study using a new urinary albuterol (salbutamol) assay technique. Chest. 1995 Mar;107(3):629-33. doi: 10.1378/chest.107.3.629.
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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 Pharmeceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A006 DPI and Proventil® MDI in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 1 site 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 10 inclusion and 9 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 1 site 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. 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?
Area Under the Curve of Drug Concentration versus Time (AUC[0-t]) (time frame: Within 30 minutes prior to dosing (baseline) to 8 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02271334, which also lists 4 linked publications.
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.