AsthmaPhase 2NCT01581177
Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation
A Phase 2 study testing Albuterol DPI 25 mcg/inh, Albuterol DPI 90 mcg/inh and Albuterol MDI 90 mcg/inh in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 4 sites in United States.
Trial summary
The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- Albuterol DPI 25 mcg/inh, Albuterol DPI 90 mcg/inh and Albuterol MDI 90 mcg/inh
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2012to Aug 2012
- 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
- Generally healthy, male and female adults, 18-55 years of age at screening
- With mild-to-moderate persistent asthma for at least 6 months prior to screening and having used a beta-agonist(s) inhaler
- Demonstrate a Forced Expiratory Volume (FEV1) at 50-85 percent of predicted normal during screening baseline measurement
- Demonstrate an airway reversibility of greater than or equal to 15 percent within 30 minutes of inhaling 2 inhalations of Proventil MDI during screening visit
- Demonstrate Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training), at least 2 times consecutively
- Demonstrate ability to use a DPI and MDI inhaler properly after training
- Females must be not pregnant, not lactating, and using a clinically acceptable form of birth control
- Properly agree to participate in the trial
Who cannot join
- A smoking history of more than or equal to 10 years or having smoked within 6 months of screening visit
- Upper respiratory tract infections within 2 weeks or lower respiratory tract infection within 4 weeks prior to screening visit
- Asthma exacerbations that required emergency care or a hospital stay within 4 weeks prior to screening visit
- Any current or recent respiratory tract infections that might affect the response to the study drug as determined by the investigator, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema and other significant respiratory diseases besides asthma
- Current clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant or other illnesses that could impact the study as determined by the investigator
- Known intolerance or hypersensitivity to any ingredients of the study drug DPI or Proventil MDI (i.e.: Albuterol, sulfate, lactose, milk protein, HFA-134a, oleic acid and ethanol)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Amphastar Site 0025
Medford, Oregon, 97504
Amphastar Site 0030
New Braunfels, Texas, 78130
Amphastar Site 0032
San Antonio, Texas, 78229
Amphastar Site 0001
San Jose, California, 95117
About this study
Official title: A Randomized, Double- or Evaluator-blind, Active- and Placebo-controlled, Single Dose, Seven-arm, Crossover Dose-ranging Study of A006 in Adult Asthma Patients
The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.
This study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma for at least 6 months, but are otherwise generally healthy.
Read the detailed description
The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dose in comparison to the DPI Placebo Control and the Active (Reference) Control. The study results of this study together with that of A006-B study will be utilized to determine the optimum final dose range of A006 for further clinical studies.
The study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma but are otherwise generally healthy.
- Conditions
- Asthma
- Being tested
- Albuterol DPI 25 mcg/inh, Albuterol DPI 90 mcg/inh, Placebo DPI, Albuterol MDI 90 mcg/inh
- Keywords
- asthma, mild-to-moderate persistent asthma, mild asthma, moderate asthma, persistent asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol DPI 25 mcg/inhDrug
Albuterol DPI with 25 mcg Albuterol/inhalation
Albuterol DPI 90 mcg/inhDrug
Albuterol DPI with 90 mcg Albuterol/inhalation
Placebo DPIDrug
Placebo DPI with 0 mcg Albuterol/inhalation
Albuterol MDI 90 mcg/inhDrug
Albuterol MDI with 90 mcg Albtuerol/inhalation
| Study group | Role | What they receive |
|---|---|---|
| T1 | Experimental | Two inhalations, one of Albuterol DPI 25 mcg/inh and one of Placebo DPI; Total Albuterol dose of 25 mcg Receives: Drug: Albuterol DPI 25 mcg/inh; Drug: Placebo DPI |
| T2 | Experimental | Two inhalations of Albuterol DPI 25 mcg/inh; Total Albuterol dose of 50 mcg Receives: Drug: Albuterol DPI 25 mcg/inh |
| T3 | Experimental | Two inhalations, one of Albuterol DPI 90 mcg/inh and one of Placebo DPI; Total Albuterol dose of 90 mcg Receives: Drug: Albuterol DPI 90 mcg/inh; Drug: Placebo DPI |
| T4 | Experimental | Two inhalations of Albuterol DPI 90 mcg/inh; Total Albuterol dose of 180 mcg Receives: Drug: Albuterol DPI 90 mcg/inh |
| P | Placebo comparator | Two inhalations Placebo DPI; Total Albuterol dose of 0 mcg Receives: Drug: Placebo DPI |
| R1 | Active comparator | One inhalation of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 90 mcg Receives: Drug: Albuterol MDI 90 mcg/inh |
| R2 | Active comparator | Two inhalations of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 180 mcg Receives: Drug: Albuterol MDI 90 mcg/inh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 Area Under the Curve (AUC) versus placebo
Serial FEV1 measurements to demonstrate the mean AUC change in percent FEV1 from same-day baseline of A006 versus placebo control
Measured: Visits 1-7, at baseline, 5, 20, 30, 60, 90, 120, 240, 360 minutes post-dose
Secondary outcomes (21)
Placebo AUC of adjusted FEV1 changes
Determination of change of FEV1 in placebo arm
Measured: Visits 1-7 at baseline, 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose
AUC of post-dose FEV1 volume changes from pre-dose baseline to Visit 7
Determination of FEV1 volume change from pre-dose baseline to post treatment at Visit 7
Measured: Visits 1-7 at baseline, 5, 20, 30, 60, 90, 120, 180, 240, 360 minutes post-dose
Time post-dose change in FEV1 percent first reaches greater than or equal to 12 percent over the Pre-dose Baseline
Time to onset of bronchodilator effect (Tonset), determined by linear interpolation as the point where post-dose change in FEV1 percent first reaches greater than or equal to 12 percent over the Pre-dose Baseline.
Measured: Visits 1-7, at 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose
Peak bronchodilator response (Fmax)
The peak bronchodilator response (Fmax), defined as the maximum post-dose change in FEV1 percent.
Measured: Visits 1-7 at 5, 20, 30, 60, 90, 120, 180, 240, 360 minutes post-dose
Time to peak FEV1 effect (tmax)
The time to peak FEV1 effect (tmax), defined as the time of Fmax.
Measured: Visits 1-7 at 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose
Duration of effect
Duration of effect, calculated as the total duration of bronchodilator effects when change in FEV1 percent is greater than or equal to 12 percent above baseline.
Measured: Visits 1-7 at 5, 20, 30, 60, 90, 120, 180 and 360 minutes post-dose
Bronchodilatory Response Rate (R percent)
Evaluation of Bronchodilatory Response Rate (R percent) of responders who demonstrate a greater than or equal to 12 percent increase for change in FEV1 percent during the initial 60 min post-dose.
Measured: Visits 1-7 at 60 minutes
Dose response curve: AUC of change in percent FEV1 versus Dose
Evaluation of change in FEV1 in relation to dose.
Measured: Visits 1-7
Vital Signs (i.e.: blood pressure and heart rate)
Vital signs, i.e. blood pressure (SBP/DBP) and heart rate (HR), at pre-dose baseline, and 3, 8, 15, 30, 90, and 360 min post-dose.
Measured: Visits 1-7 and EOS at baseline, 3, 8, 15, 30, 90 and 360 minutes post-dose
12-lead ECG (for routine and QT/QTc)
Measurement of 12-lead ECG (for routine and QT/QTc), at pre-dose baseline, and at 10, 50, and 360 min post-dose.
Measured: Visits 1-7 at baseline, 10, 50 and 360 minutes post-dose
Serum glucose
Determination of Serum glucose, at pre-dose baseline, and at 15, 35 and 120 min post-dose.
Measured: Visits 1-7 at baseline, 15, 35 and 120 minutes post-dose
Serum potassium
Determination of serum potassium levels, at pre-dose baseline, and at 15, 35 and 120 min post-dose.
Measured: Visits 1-7 at baseline, 15, 35 and 120 minutes post-dose
Asthma exacerbation incidents
Evaluation of asthma exacerbation incidents in all patients throughout the duration of the study.
Measured: Visits 1-7 and EOS
Asthma management/ rescue drug usage
Evaluation of asthma exacerbation incidents in all patients throughout the duration of the study.
Measured: Visits 1-7 and EOS
Physical examination
Physical examination of all subjects performed at screening and end-of-study visit to evaluate subject's general health.
Measured: Screening and End-of-Study Visit
CBC
Evaluation of CBC in all subjects at screening and end-of-study visit.
Measured: Screening and End-of-Study Visit
Comprehensive metabolic panel
Comprehensive metabolic panel performed on all subjects at screening and end-of-study visit.
Measured: Screening and End-of-Study Visit
Urinalysis
Urinalysis performed on all subjects at screening and end-of-study visit.
Measured: Screening and End-of-Study Visit
Pregnancy test
A pregnancy test for women of child bearing potential at screening and end-of-study visit.
Measured: Screening and End-of-Study Visit
Medication interactions
Evaluation of concomitant medications used by subjects throughout the study and their potential to affect the study
Measured: Screening, Visits 1-7 and End-of-Study Visit
Number of participants with adverse events as a measure of safety and tolerability
Adverse drug events whether observed by investigators or reported by subjects, will be documented, evaluated, followed up, and treated if deemed necessary.
Measured: Screening, Visits 1-7, End-of-Study Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 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
- NCT01581177
- Sponsor's protocol ID
- API-A006-CL-B2
- Status last verified
- May 2017
- First submitted
- 17 Apr 2012
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
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 7874928Crapo RO, Morris AH, Gardner RM. Reference spirometric values using techniques and equipment that meet ATS recommendations. Am Rev Respir Dis. 1981 Jun;123(6):659-64. doi: 10.1164/arrd.1981.123.6.659.
PubMed 7271065Crapo RO, Morris AH, Clayton PD, Nixon CR. Lung volumes in healthy nonsmoking adults. Bull Eur Physiopathol Respir. 1982 May-Jun;18(3):419-25.
PubMed 7074238
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double- or Evaluator-blind, Active- and Placebo-controlled, Single Dose, Seven-arm, Crossover Dose-ranging Study of A006 in Adult Asthma Patients
- ClinicalTrials.gov ID
- NCT01581177
- Acronym / sponsor ID
- API-A006-CL-B2
- Conditions
- Asthma
- Keywords
- asthma, mild-to-moderate persistent asthma, mild asthma, moderate asthma, persistent asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Amphastar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Apr 2012 (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 main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.
This study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma for at least 6 months, but are otherwise generally healthy.
Detailed description
The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dose in comparison to the DPI Placebo Control and the Active (Reference) Control. The study results of this study together with that of A006-B study will be utilized to determine the optimum final dose range of A006 for further clinical studies.
The study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma but are otherwise generally healthy.
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 DPI 25 mcg/inh, Drug: Placebo DPITwo inhalations, one of Albuterol DPI 25 mcg/inh and one of Placebo DPI; Total Albuterol dose of 25 mcg |
| T2 | Experimental | Drug: Albuterol DPI 25 mcg/inhTwo inhalations of Albuterol DPI 25 mcg/inh; Total Albuterol dose of 50 mcg |
| T3 | Experimental | Drug: Albuterol DPI 90 mcg/inh, Drug: Placebo DPITwo inhalations, one of Albuterol DPI 90 mcg/inh and one of Placebo DPI; Total Albuterol dose of 90 mcg |
| T4 | Experimental | Drug: Albuterol DPI 90 mcg/inhTwo inhalations of Albuterol DPI 90 mcg/inh; Total Albuterol dose of 180 mcg |
| P | Placebo comparator | Drug: Placebo DPITwo inhalations Placebo DPI; Total Albuterol dose of 0 mcg |
| R1 | Active comparator | Drug: Albuterol MDI 90 mcg/inhOne inhalation of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 90 mcg |
| R2 | Active comparator | Drug: Albuterol MDI 90 mcg/inhTwo inhalations of Albuterol MDI 90 mcg/inh; Total Albuterol dose of 180 mcg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Generally healthy, male and female adults, 18-55 years of age at screening
- With mild-to-moderate persistent asthma for at least 6 months prior to screening and having used a beta-agonist(s) inhaler
- Demonstrate a Forced Expiratory Volume (FEV1) at 50-85 percent of predicted normal during screening baseline measurement
- Demonstrate an airway reversibility of greater than or equal to 15 percent within 30 minutes of inhaling 2 inhalations of Proventil MDI during screening visit
- Demonstrate Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training), at least 2 times consecutively
Key exclusion criteria (6 listed)
- A smoking history of more than or equal to 10 years or having smoked within 6 months of screening visit
- Upper respiratory tract infections within 2 weeks or lower respiratory tract infection within 4 weeks prior to screening visit
- Asthma exacerbations that required emergency care or a hospital stay within 4 weeks prior to screening visit
- Any current or recent respiratory tract infections that might affect the response to the study drug as determined by the investigator, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema and other significant respiratory diseases besides asthma
- Current clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant or other illnesses that could impact the study as determined by the investigator
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 DPI 25 mcg/inhAlbuterol DPI with 25 mcg Albuterol/inhalation | Drug | T1, T2 |
| Albuterol DPI 90 mcg/inhAlbuterol DPI with 90 mcg Albuterol/inhalation | Drug | T3, T4 |
| Placebo DPIPlacebo DPI with 0 mcg Albuterol/inhalation | Drug | P, T1, T3 |
| Albuterol MDI 90 mcg/inhAlbuterol MDI with 90 mcg Albtuerol/inhalation | Drug | R1, R2 |
Primary outcome
Change in FEV1 Area Under the Curve (AUC) versus placebo
Time frame: Visits 1-7, at baseline, 5, 20, 30, 60, 90, 120, 240, 360 minutes post-dose
Serial FEV1 measurements to demonstrate the mean AUC change in percent FEV1 from same-day baseline of A006 versus placebo control
21 secondary outcomes
Placebo AUC of adjusted FEV1 changes
Time frame: Visits 1-7 at baseline, 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose
AUC of post-dose FEV1 volume changes from pre-dose baseline to Visit 7
Time frame: Visits 1-7 at baseline, 5, 20, 30, 60, 90, 120, 180, 240, 360 minutes post-dose
Time post-dose change in FEV1 percent first reaches greater than or equal to 12 percent over the Pre-dose Baseline
Time frame: Visits 1-7, at 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose
Peak bronchodilator response (Fmax)
Time frame: Visits 1-7 at 5, 20, 30, 60, 90, 120, 180, 240, 360 minutes post-dose
Time to peak FEV1 effect (tmax)
Time frame: Visits 1-7 at 5, 20, 30, 60, 90, 120, 180, 240 and 360 minutes post-dose
Duration of effect
Time frame: Visits 1-7 at 5, 20, 30, 60, 90, 120, 180 and 360 minutes post-dose
Bronchodilatory Response Rate (R percent)
Time frame: Visits 1-7 at 60 minutes
Dose response curve: AUC of change in percent FEV1 versus Dose
Time frame: Visits 1-7
Vital Signs (i.e.: blood pressure and heart rate)
Time frame: Visits 1-7 and EOS at baseline, 3, 8, 15, 30, 90 and 360 minutes post-dose
12-lead ECG (for routine and QT/QTc)
Time frame: Visits 1-7 at baseline, 10, 50 and 360 minutes post-dose
Serum glucose
Time frame: Visits 1-7 at baseline, 15, 35 and 120 minutes post-dose
Serum potassium
Time frame: Visits 1-7 at baseline, 15, 35 and 120 minutes post-dose
Asthma exacerbation incidents
Time frame: Visits 1-7 and EOS
Asthma management/ rescue drug usage
Time frame: Visits 1-7 and EOS
Physical examination
Time frame: Screening and End-of-Study Visit
CBC
Time frame: Screening and End-of-Study Visit
Comprehensive metabolic panel
Time frame: Screening and End-of-Study Visit
Urinalysis
Time frame: Screening and End-of-Study Visit
Pregnancy test
Time frame: Screening and End-of-Study Visit
Medication interactions
Time frame: Screening, Visits 1-7 and End-of-Study Visit
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Screening, Visits 1-7, End-of-Study Visit
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 May 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.
- Background: PubMed 7271065Crapo RO, Morris AH, Gardner RM. Reference spirometric values using techniques and equipment that meet ATS recommendations. Am Rev Respir Dis. 1981 Jun;123(6):659-64. doi: 10.1164/arrd.1981.123.6.659.
- Background: PubMed 7074238Crapo RO, Morris AH, Clayton PD, Nixon CR. Lung volumes in healthy nonsmoking adults. Bull Eur Physiopathol Respir. 1982 May-Jun;18(3):419-25.
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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 DPI 25 mcg/inh, Albuterol DPI 90 mcg/inh and Albuterol MDI 90 mcg/inh in people with Asthma, 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 8 inclusion and 6 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 May 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?
Change in FEV1 Area Under the Curve (AUC) versus placebo (time frame: Visits 1-7, at baseline, 5, 20, 30, 60, 90, 120, 240, 360 minutes post-dose). 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 NCT01581177, which also lists 6 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 May 2017.