AsthmaPhase 3NCT00635505
Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients
A Phase 3 study testing albuterol HFA (Armstrong's) and albuterol HFA (Proventil HFA) in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 42 sites in United States.
Trial summary
This 12-week clinical study evaluates the safety and efficacy of Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA, or: A004), Armstrong's proposed HFA formulation of metered dose inhaler (MDI) of Albuterol (Treatment T), in comparison with: 1. Placebo control: (HFA propellant only, Treatment P); and 2. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- albuterol HFA (Armstrong's) and albuterol HFA (Proventil HFA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 42 sitesUnited States
- Study dates
- Sep 2007to Aug 2008
- Phase
- Phase 3
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female asthma patients aged 12 - 75 years, in general good health.
- A documented history of mild to moderate asthma, for at-least 6-months prior to Screening, requiring inhaled B2-adrenergic agonists, with or without orally inhaled corticosteroids, for asthma treatment.
- Satisfying criteria of asthma stability, defined as no asthma-related hospitalization or emergency visits, and no significant changes in asthma therapy, over 4 weeks prior to Screening (with exception for switching from long- to short-acting B2-agonists).
- Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout periods indicated in Appendix II prior to the Screening Baseline FEV1 testing.
- Having a Screening Baseline FEV1 test that falls within 50-90% of the predicted values.
- Airway Reversibility PFT at screening should demonstrate a greater than 12% increase in FEV1 at 30 minutes of inhaling 2 actuations of Ventolin-HFA (180 mcg albuterol base).
Show all 9Show fewer
- Demonstrating satisfactory techniques in the use of metered-dose inhaler (MDIs) and a hand held peak flow meter.
- Female patients of child-bearing potential being non-pregnant and non-lactating at Screening and throughout the study, and using an acceptable method of contraception during the study.
- Has properly consented to participate in this study.
Who cannot join
- Male and female asthma patients aged 12 - 75 years, in general good health.
- A documented history of mild to moderate asthma, for at-least 6-months prior to Screening, requiring inhaled B2-adrenergic agonists, with or without orally inhaled corticosteroids, for asthma treatment.
- Satisfying criteria of asthma stability, defined as no asthma-related hospitalization or emergency visits, and no significant changes in asthma therapy, over 4 weeks prior to Screening (with exception for switching from long- to short-acting B2-agonists).
- Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout periods indicated in Appendix II prior to the Screening Baseline FEV1 testing.
- Having a Screening Baseline FEV1 test that falls within 50-90% of the predicted values.
- Airway Reversibility PFT at screening should demonstrate a greater than12% increase in FEV1 at 30 minutes of inhaling 2 actuations of Ventolin-HFA (180 mcg albuterol base).
Show all 9Show fewer
- Demonstrating satisfactory techniques in the use of metered-dose inhaler (MDIs) and a hand held peak flow meter.
- Female patients of child-bearing potential being non-pregnant and non-lactating at Screening and throughout the study, and using an acceptable method of contraception during the study.
- Has properly consented to participate in this study.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Integrated Medical Research
Ashland, Oregon, 97520
Clinical Research Group of Montana
Bozeman, Montana, 59718
New Horizons Clinical Research
Cincinnati, Ohio, 45242
Pharmaceutical Research & Consulting, Inc.
Dallas, Texas, 25231
Colorado Allergy and Asthma Centers
Denver, Colorado, 80230
Allergy & Asthma Research Group
Eugene, Oregon, 97504
Allergy and Asthma Associates of Houston
Houston, Texas, 77054
Clinical Trials of North Houston
Houston, Texas, 77070
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, 92647
Kerrville Allergy and Asthma Associates
Kerrville, Texas, 78028
Allergy Asthma and Dermatology Research
Lake Oswego, Oregon, 97035
Colorado Allergy and Asthma Centers
Lakewood, Colorado, 80401
Allergy Asthma & Respiratory Care Medical Center
Long Beach, California, 90806
Allergy & Asthma Care Center
Long Beach, California, 90808
Family Allergy and Asthma Research Institute
Louisville, Kentucky, 40215
Clinical Research Institute of Southern Oregon
Medford, Oregon, 97504
Park Nicollet Institute
Minneapolis, Minnesota, 55416
Southern California Research
Mission Viejo, California, 92691
Montant Medical Research
Missoula, Montana, 59808
Pulmonary Associates of Mobile, PC
Mobile, Alabama, 36608
Northeast Medical Research Group
North Dartmouth, Massachusetts, 02747
Allergy and Asthma Care of Florida
Ocala, Florida, 34471
CHOC PSF, AMC, Divison AA and I
Orange, California, 92868
Clinical Trials of Orange County
Orange, California, 92868
Asthma and Allergy Center, PC
Papillion, Nebraska, 68046
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
Allergy Associates Research Center
Portland, Oregon, 97213
Virginia Adult and Pediatric Allergy and Asthma, PC
Richmond, Virginia, 23229
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Biogenics Research Institute
San Antonio, Texas, 78229
Sylvania Research Associates
San Antonio, Texas, 78229
Allergy Associates Medical Group
San Diego, California, 92120
Allergy & Asthma Associates of Santa Clara Valley Research Centere
San Jose, California, 95117
Asthma, Inc.
Seattle, Washington, 98105
MEDEX Healthcare Research, Inc.
St Louis, Missouri, 63117
The Clinical Research Center, LLC
St Louis, Missouri, 63141
Bensch Research Associates
Stockton, California, 95207
Toledo Center for Clinical Research
Sylvania, Ohio, 43560
Brandon-Valrico Center for Allergy and Astham Research,LLC
Valrico, Florida, 33594
Waterbury Pulmonary Research
Waterbury, Connecticut, 06708
Rocky Mountain center for Clinical Research
Wheat Ridge, Colorado, 80033
Atlanta Allergy and Asthma Clinic
Woodstock, Georgia, 30188
About this study
Official title: Randomized, Placebo-Controlled, Parallel, Multi-Center, 12-Week Study to Evaluate the Efficacy and Safety of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Adult and Adolescent Asthmatic Patients
This 12-week clinical study evaluates the safety and efficacy of Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA, or: A004), Armstrong's proposed HFA formulation of metered dose inhaler (MDI) of Albuterol (Treatment T), in comparison with:
- Placebo control: (HFA propellant only, Treatment P); and
- Active control: 3M/Key's Proventil-HFA (Treatment R).
The treatments will be given as self-administered oral inhalations in adult and adolescent patients with mild-to-moderate asthma, for 12-weeks. Dosing regimen throughout the 12-week study is two actuations four times daily (QID).
Read the detailed description
This is a randomized, parallel, multicenter, 12-week study in adolescent and adult patients with mild-to-moderate asthma, to evaluate the efficacy and safety of Armstrong's Albuterol-HFA MDI, in comparison to a Placebo Control and an Active Control of Proventil-HFA. While Albuterol-HFA (Treatment T) and Placebo (Treatment P) will be double-blinded to both the subjects and investigational staff, the active comparator drug, Proventil-HFA (Treatment R), can only be evaluator-blinded, due to: (1) its physical appearance differing from that of the T and P devices; and (2) unavailability of a Proventil-HFA placebo which would otherwise be used for a double-dummy design. All study medications will have the canisters and all product-identifying text or graphics (e.g., molded text on actuator) masked so that the treatments cannot be identified. No subject in any study arm will be given any information that could reveal the nature of the treatment given. All study subjects will be instructed not to reveal or discuss the study medications to the study staff or other subjects. The designated study evaluator(s), who conduct the clinical visits and safety and efficacy evaluations and perform the data recording and transcription, will be blinded to the study medications.
All subjects will be screened for enrollment, and will be randomized into the following three treatment groups in a double-blinded (for Treatments T and P) or evaluator-blinded (for Treatment R) manner:
Treatment T (Albuterol-HFA, N=200): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment R (Proventil-HFA, N=50): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment P (Placebo-HFA, N=50): two actuations of placebo, QID.
Randomization is achieved with blocks of six (6), with four (4) patients receiving Albuterol-HFA for every one (1) patient receiving Proventil-HFA and every one (1) receiving the Placebo-HFA. At each Clinical Visit that takes place every 3 weeks, the double-blinded (T, P) or evaluator-blinded (R) study drugs will be distributed in resealable masking pouches to the subjects of each arm.
An additional aim of the study is to evaluate the effect of weekly cleaning on the Albuterol-HFA MDI device clinical performance throughout the four, 3-week life-of-device treatment cycles, in conformance with the FDA's specific requirements.
Arms:
All subjects will be screened for enrollment, and will be randomized into the following three treatment groups in a double-blinded (for Treatments T and P) or evaluator-blinded (for Treatment R) manner:
Treatment T (Albuterol-HFA, N=200): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment R (Proventil-HFA, N=50): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment P (Placebo-HFA, N=50): two actuations of placebo, QID.
- Conditions
- Asthma
- Being tested
- albuterol HFA (Armstrong's), albuterol HFA (Proventil HFA), HFA placebo
- Keywords
- Asthma, albuterol, HFA
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albuterol HFA (Armstrong's)Drug
180 mcg QID 12 weeks
albuterol HFA (Proventil HFA)Drug
Also called Proventil HFA
180 mcg QID 12 weeks
HFA placeboDrug
2 actuations QID 12 weeks or until use of rescue drug
| Study group | Role | What they receive |
|---|---|---|
| T | Experimental | albuterol HFA 180 mcg QID Receives: Drug: albuterol HFA (Armstrong's) |
| R | Active comparator | 180 mcg QID 12 weeks Receives: Drug: albuterol HFA (Proventil HFA) |
| P | Placebo comparator | 2 actuations QID 12 weeks or until use of rescue drug Receives: Drug: HFA placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the bronchodilator effect expressed as the mean area under the curve (AUC) of FEV1 (% change from Same-Day Baseline FEV1) versus time.
Measured: Concurent with each visit
Secondary outcomes (20)
The comparative analysis of AUC of FEV1 (% change from the Same-Day Baseline) versus time, for bronchodilator effect (between Albuterol-HFA and Proventil-HFA).
Measured: End of Study
AUC of FEV1-time curve (changes of actual volumes from the Same-Day Baseline).
Measured: End of Study
Time to onset of bronchodilator effect, determined by linear interpolation as the time point where FEV1 first reaches 12% over Same-Day Baseline.
Measured: End of Study
The peak bronchodilator response, defined as the maximum FEV1 (% change from Same-Day Baseline) post-dose.
Measured: end of study
The time to peak FEV1 effect, measured as the time point of peak response, as defined (4) above.
Measured: End of Study
Duration of bronchodilator effect, defined as the total length of time when FEV1 is maintained 12% above the respective Same-Day Baseline values (time points calculated with linear interpolation).
Measured: Concurrent with each visit
Percentage of positive responders including those whose FEV1 exceed the Same-Day Baseline by 12% within 30 minutes post-dose (quick responders), and during the entire 6 hr post-dose (overall responders).
Measured: Concurrent with visit
Number of inhalations of the rescue inhalers taken.
Measured: Concurrent with each visit
Global assessment of Overall Asthma Control Scores by investigators.
Measured: End of Study
Total daytime asthma symptom scores.
Measured: End of Study
Nighttime sleep disturbance scores.
Measured: End of Study
Morning pre-dose Peak Expiratory Flow Rate (PEF).
Measured: Concurrent with each visit
The clinical performances of the Albuterol-HFA MDI at the representative first, middle and last one third of the usable life stage, are compared with each other, and are also compared to those of the active control, Proventil-HFA.
Measured: End of Study
The in vitro performance of the Albuterol-HFA MDI will be evaluated.
Measured: Concurrent with each visit
Vital signs (SBP/DBP, and heart rate) will be monitored at Clinical Visit 1, 3 and 5, at baseline (within 30 minutes prior to dosing), and 90+/-15 min, and 360+/-30 min, post-dose.
Measured: concurrent with study visits as noted
A 12-lead ECG (for HR, QT and QTc intervals) will be recorded at Screening Visit, and at baseline (within 30 min) pre-dose and at 90+/-15 min post-dose (predicted time of peak effect).
Measured: Clinical Visits 1 and 5
Data for CBC, blood chemistry panel (8-hr fasted), and urinalysis.
Measured: Screening and end-of-study
Study compliance and diaries will be reviewed
Measured: at all cliniical visits
Concomitant medications will be reviewed and recorded
Measured: each study visit
Adverse events/side effects whether observed by investigators or reported by subjects, will be documented, evaluated, followed up, and treated if deemed necessary.
Measured: concurrent with each study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: IND voluntarily withdrawn, without prejudice
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amphastar Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635505
- Sponsor's protocol ID
- API-A004-CLN-C
- Status last verified
- Jul 2012
- First submitted
- 7 Mar 2008
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled, Parallel, Multi-Center, 12-Week Study to Evaluate the Efficacy and Safety of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Adult and Adolescent Asthmatic Patients
- ClinicalTrials.gov ID
- NCT00635505
- Acronym / sponsor ID
- API-A004-CLN-C
- Conditions
- Asthma
- Keywords
- Asthma, albuterol, HFA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IND voluntarily withdrawn, without prejudice
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Amphastar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 13 Mar 2008 (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 12-week clinical study evaluates the safety and efficacy of Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA, or: A004), Armstrong's proposed HFA formulation of metered dose inhaler (MDI) of Albuterol (Treatment T), in comparison with:
- Placebo control: (HFA propellant only, Treatment P); and
- Active control: 3M/Key's Proventil-HFA (Treatment R).
The treatments will be given as self-administered oral inhalations in adult and adolescent patients with mild-to-moderate asthma, for 12-weeks. Dosing regimen throughout the 12-week study is two actuations four times daily (QID).
Detailed description
This is a randomized, parallel, multicenter, 12-week study in adolescent and adult patients with mild-to-moderate asthma, to evaluate the efficacy and safety of Armstrong's Albuterol-HFA MDI, in comparison to a Placebo Control and an Active Control of Proventil-HFA. While Albuterol-HFA (Treatment T) and Placebo (Treatment P) will be double-blinded to both the subjects and investigational staff, the active comparator drug, Proventil-HFA (Treatment R), can only be evaluator-blinded, due to: (1) its physical appearance differing from that of the T and P devices; and (2) unavailability of a Proventil-HFA placebo which would otherwise be used for a double-dummy design. All study medications will have the canisters and all product-identifying text or graphics (e.g., molded text on actuator) masked so that the treatments cannot be identified. No subject in any study arm will be given any information that could reveal the nature of the treatment given. All study subjects will be instructed not to reveal or discuss the study medications to the study staff or other subjects. The designated study evaluator(s), who conduct the clinical visits and safety and efficacy evaluations and perform the data recording and transcription, will be blinded to the study medications.
All subjects will be screened for enrollment, and will be randomized into the following three treatment groups in a double-blinded (for Treatments T and P) or evaluator-blinded (for Treatment R) manner:
Treatment T (Albuterol-HFA, N=200): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment R (Proventil-HFA, N=50): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment P (Placebo-HFA, N=50): two actuations of placebo, QID.
Randomization is achieved with blocks of six (6), with four (4) patients receiving Albuterol-HFA for every one (1) patient receiving Proventil-HFA and every one (1) receiving the Placebo-HFA. At each Clinical Visit that takes place every 3 weeks, the double-blinded (T, P) or evaluator-blinded (R) study drugs will be distributed in resealable masking pouches to the subjects of each arm.
An additional aim of the study is to evaluate the effect of weekly cleaning on the Albuterol-HFA MDI device clinical performance throughout the four, 3-week life-of-device treatment cycles, in conformance with the FDA's specific requirements.
Arms:
All subjects will be screened for enrollment, and will be randomized into the following three treatment groups in a double-blinded (for Treatments T and P) or evaluator-blinded (for Treatment R) manner:
Treatment T (Albuterol-HFA, N=200): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment R (Proventil-HFA, N=50): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment P (Placebo-HFA, N=50): two actuations of placebo, QID.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T | Experimental | Drug: albuterol HFA (Armstrong's)albuterol HFA 180 mcg QID |
| R | Active comparator | Drug: albuterol HFA (Proventil HFA)180 mcg QID 12 weeks |
| P | Placebo comparator | Drug: HFA placebo2 actuations QID 12 weeks or until use of rescue drug |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female asthma patients aged 12 - 75 years, in general good health.
- A documented history of mild to moderate asthma, for at-least 6-months prior to Screening, requiring inhaled B2-adrenergic agonists, with or without orally inhaled corticosteroids, for asthma treatment.
- Satisfying criteria of asthma stability, defined as no asthma-related hospitalization or emergency visits, and no significant changes in asthma therapy, over 4 weeks prior to Screening (with exception for switching from long- to short-acting B2-agonists).
- Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout periods indicated in Appendix II prior to the Screening Baseline FEV1 testing.
- Having a Screening Baseline FEV1 test that falls within 50-90% of the predicted values.
Key exclusion criteria (9 listed)
- Male and female asthma patients aged 12 - 75 years, in general good health.
- A documented history of mild to moderate asthma, for at-least 6-months prior to Screening, requiring inhaled B2-adrenergic agonists, with or without orally inhaled corticosteroids, for asthma treatment.
- Satisfying criteria of asthma stability, defined as no asthma-related hospitalization or emergency visits, and no significant changes in asthma therapy, over 4 weeks prior to Screening (with exception for switching from long- to short-acting B2-agonists).
- Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout periods indicated in Appendix II prior to the Screening Baseline FEV1 testing.
- Having a Screening Baseline FEV1 test that falls within 50-90% of the predicted values.
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 HFA (Armstrong's)180 mcg QID 12 weeks | Drug | T |
| albuterol HFA (Proventil HFA)Also: Proventil HFA180 mcg QID 12 weeks | Drug | R |
| HFA placebo2 actuations QID 12 weeks or until use of rescue drug | Drug | P |
Primary outcome
The primary endpoint is the bronchodilator effect expressed as the mean area under the curve (AUC) of FEV1 (% change from Same-Day Baseline FEV1) versus time.
Time frame: Concurent with each visit
20 secondary outcomes
The comparative analysis of AUC of FEV1 (% change from the Same-Day Baseline) versus time, for bronchodilator effect (between Albuterol-HFA and Proventil-HFA).
Time frame: End of Study
AUC of FEV1-time curve (changes of actual volumes from the Same-Day Baseline).
Time frame: End of Study
Time to onset of bronchodilator effect, determined by linear interpolation as the time point where FEV1 first reaches 12% over Same-Day Baseline.
Time frame: End of Study
The peak bronchodilator response, defined as the maximum FEV1 (% change from Same-Day Baseline) post-dose.
Time frame: end of study
The time to peak FEV1 effect, measured as the time point of peak response, as defined (4) above.
Time frame: End of Study
Duration of bronchodilator effect, defined as the total length of time when FEV1 is maintained 12% above the respective Same-Day Baseline values (time points calculated with linear interpolation).
Time frame: Concurrent with each visit
Percentage of positive responders including those whose FEV1 exceed the Same-Day Baseline by 12% within 30 minutes post-dose (quick responders), and during the entire 6 hr post-dose (overall responders).
Time frame: Concurrent with visit
Number of inhalations of the rescue inhalers taken.
Time frame: Concurrent with each visit
Global assessment of Overall Asthma Control Scores by investigators.
Time frame: End of Study
Total daytime asthma symptom scores.
Time frame: End of Study
Nighttime sleep disturbance scores.
Time frame: End of Study
Morning pre-dose Peak Expiratory Flow Rate (PEF).
Time frame: Concurrent with each visit
The clinical performances of the Albuterol-HFA MDI at the representative first, middle and last one third of the usable life stage, are compared with each other, and are also compared to those of the active control, Proventil-HFA.
Time frame: End of Study
The in vitro performance of the Albuterol-HFA MDI will be evaluated.
Time frame: Concurrent with each visit
Vital signs (SBP/DBP, and heart rate) will be monitored at Clinical Visit 1, 3 and 5, at baseline (within 30 minutes prior to dosing), and 90+/-15 min, and 360+/-30 min, post-dose.
Time frame: concurrent with study visits as noted
A 12-lead ECG (for HR, QT and QTc intervals) will be recorded at Screening Visit, and at baseline (within 30 min) pre-dose and at 90+/-15 min post-dose (predicted time of peak effect).
Time frame: Clinical Visits 1 and 5
Data for CBC, blood chemistry panel (8-hr fasted), and urinalysis.
Time frame: Screening and end-of-study
Study compliance and diaries will be reviewed
Time frame: at all cliniical visits
Concomitant medications will be reviewed and recorded
Time frame: each study visit
Adverse events/side effects whether observed by investigators or reported by subjects, will be documented, evaluated, followed up, and treated if deemed necessary.
Time frame: concurrent with each study visit
Results and safety
The study was stopped early (reason given: IND voluntarily withdrawn, without prejudice). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing albuterol HFA (Armstrong's) and albuterol HFA (Proventil HFA) in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 42 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 9 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: stopped early, as of the sponsor's last update on 15 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: IND voluntarily withdrawn, without prejudice). Results are not available in the source record.
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?
The primary endpoint is the bronchodilator effect expressed as the mean area under the curve (AUC) of FEV1 (% change from Same-Day Baseline FEV1) versus time. (time frame: Concurent with each visit). 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 15 Jul 2013.