A Phase 3 interventional study of Placebo Spiromax and Albuterol Spiromax in Asthma, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Terminated at 30 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2015-05-20.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 3, Interventional, and Treatment
This is a one-year study to look at the safety of a dry powder inhaler with albuterol. After a one-week run in, for the first 3 months subjects will use an inhaler with either albuterol or a dummy drug at regular times four times a day. Then for the last nine months of the study, all subjects will be given the albuterol dry powder inhaler and will use it only when needed to help with breathing problems. Subjects will need to keep a daily diary (both paper and electronic) throughout the study recording any inhaler use and health problems. There will be visits to the study doctor about once a month for a year. This study is intended to show that the albuterol dry powder inhaler works well and is safe for use over a long period of time.
The Sponsor terminated this study due to the need for a modification to the Spiromax device utilized in this study; the problem identified has no impact on patient safety. Exposure ranged from 3 to 49 days with the majority of subjects receiving ≤30 days of double-blind treatment.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 331 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Drug: Albuterol Spiromax
Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Drug: Placebo Spiromax · Drug: Albuterol Spiromax
Placebo as a dry-powder inhaled orally using the Spiromax inhaler. During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
Albuterol as a dry-powder inhaled orally using the Spiromax inhaler. Each inhalation delivers 90 micrograms (mcg). During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total dose of 720 micrograms per day for those paricipants randomized to the Albuterol treatment arm. The double-blind period is followed by a 40-week open-label period in which all study participants will take Albuterol Spiromax 90 micrograms (mcg)/inhalation as needed (PRN).
Also known as: ProAir® RespiClick, Albuterol multi-dose dry powder inhaler (MDPI)
Participants With Treatment-Emergent Adverse Events
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Time frame: Day 1 to Day 49 (study termination)
Changes From Screening in the Results of the Physical Examination That Are Clinically Significant in the Opinion of the Investigator
A complete physical examination was planned at study screening, week 12 and week 52 or early termination/discontinuation of the participant. At weeks 12 and 52,the qualified healthcare professional was to evaluate whether each physical finding is a new finding, worsening, improvement or resolution of an existing condition compared with the baseline physical exam. Where possible, the same qualified healthcare professional that performed the physical examination at study screening should perform all the scheduled physical examinations.
Time frame: Days -15 to -8 (Screening), Week 12, Week 52
Changes From Screening in the Results of the Laboratory Evaluations That Are Clinically Significant in the Opinion of the Investigator
Blood samples were to collected for laboratory evaluations at the screening visit and at weeks 12 and 52 or early termination/discontinuation of the participant. The blood samples were to be drawn after an overnight fast of at least 6 hours and analyzed by a central laboratory.
Time frame: Days -15 to -8 (Screening), Week 12, Week 52
Changes From Screening in the Results of the Electrocardiograms (ECGs) That Are Clinically Significant in the Opinion of the Investigator
A standard 12-lead ECG was to be performed at screening and at week 12 and week 52 (TV15) or early termination/discontinuation of the participant. The ECG recording methods were to be centralized and standardized across all study subjects.
Time frame: Days -15 to -8 (Screening), Week 12, Week 52
Changes From Screening in the Vital Signs That Are Clinically Significant in the Opinion of the Investigator
Vital sign measurements (heart rate and blood pressure) were to be evaluated as part of the safety profile assessment. The participant was to be seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer could be used.
Time frame: Days -15 to -8 (Screening), Week 12, Week 52
| Milestone | Albuterol Spiromax | Placebo Spiromax |
|---|---|---|
| Started | 166 | 165 |
| Completed | 0 | 0 |
| Not completed | 166 | 165 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Withdrawal by subject | 3 | 1 |
| Withdrew: Sponsor terminated study | 161 | 163 |
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
| participants | Albuterol Spiromax | Placebo Spiromax |
|---|---|---|
| Any adverse event | 59 | 58 |
| Treatment-related adverse event | 3 | 3 |
| Withdrawn from study due to adverse event | 0 | 0 |
| Serious adverse event | 1 | 1 |
| Treatment-related serious adverse event | 0 | 0 |
| Mild adverse event | 29 | 32 |
| Moderate adverse event | 35 | 29 |
| Severe adverse event | 2 | 4 |
| AE class: Infections and infestations | 31 | 34 |
| AE class: Respiratory, thoracic and mediastinal | 12 | 11 |
| AE class: Gastrointestinal | 9 | 5 |
| AE class: Nervous system | 7 | 6 |
| AE class: Injury, poisoning and procedural compli | 4 | 2 |
| AE class: Investigations | 3 | 3 |
| AE class: Musculoskeletal and connective tissue | 2 | 4 |
| AE class: Renal and urinary | 2 | 1 |
| AE class: Ear and labyrinth | 2 | 1 |
| AE class: Skin and subcutaneous tissue | 2 | 0 |
| AE class: General and administrative site conditi | 1 | 1 |
| AE class: Psychiatric | 1 | 1 |
| AE class: Social circumstances | 1 | 0 |
| AE class: Cardiac | 0 | 2 |
| AE class: Eye | 0 | 1 |
| AE class: Blood and lymphatic system | 0 | 1 |
| Neoplasm benign, malignant + unspecified | 0 | 1 |
A complete physical examination was planned at study screening, week 12 and week 52 or early termination/discontinuation of the participant. At weeks 12 and 52,the qualified healthcare professional was to evaluate whether each physical finding is a new finding, worsening, improvement or resolution of an existing condition compared with the baseline physical exam. Where possible, the same qualified healthcare professional that performed the physical examination at study screening should perform all the scheduled physical examinations.
No measurements were reported for this outcome.
Blood samples were to collected for laboratory evaluations at the screening visit and at weeks 12 and 52 or early termination/discontinuation of the participant. The blood samples were to be drawn after an overnight fast of at least 6 hours and analyzed by a central laboratory.
No measurements were reported for this outcome.
A standard 12-lead ECG was to be performed at screening and at week 12 and week 52 (TV15) or early termination/discontinuation of the participant. The ECG recording methods were to be centralized and standardized across all study subjects.
No measurements were reported for this outcome.
Vital sign measurements (heart rate and blood pressure) were to be evaluated as part of the safety profile assessment. The participant was to be seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer could be used.
No measurements were reported for this outcome.
Vital sign measurements (heart rate and blood pressure) were evaluated as part of the safety profile assessment. The participant was seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer was used.
| mmHg | Albuterol Spiromax | Placebo Spiromax |
|---|---|---|
| Screening Diastolic BP (n=166, 165) | 75.5 ± 9.24 | 75.2 ± 9.08 |
| End of Study Diastolic BP (n=164, 164) | 75.7 ± 9.54 | 75.2 ± 8.79 |
| Screening Systolic BP (n=166, 165) | 119.4 ± 13.39 | 118.0 ± 13.70 |
| End of Study Systolic BP (n=164, 164) | 118.4 ± 13.50 | 118.2 ± 12.99 |
Vital sign measurements (heart rate and blood pressure) were evaluated as part of the safety profile assessment. The participant was seated at least 2 minutes before vital signs were performed. Heart rate was measured by radial pulse.
| beats/minute | Albuterol Spiromax | Placebo Spiromax |
|---|---|---|
| Screening (n=166, 165) | 71.0 ± 8.57 | 71.8 ± 10.03 |
| End of study (n=164, 164) | 72.1 ± 9.34 | 73.0 ± 9.48 |
Collected over Day 1 to Day 49 (study termination). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Albuterol Spiromax | — | 1/166 (0.6%) | 16/166 (9.6%) |
| Placebo Spiromax | — | 1/165 (0.6%) | 20/165 (12.1%) |
| Event | Albuterol Spiromax | Placebo Spiromax |
|---|---|---|
| Rectal adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/166 | 1/165 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/166 | 0/165 |
| Event | Albuterol Spiromax | Placebo Spiromax |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 10/166 | 11/165 |
| NasopharyngitisInfections and infestations | 6/166 | 10/165 |
Randomized participants
| Age, Continuous(years) | Albuterol Spiromax | Placebo Spiromax | Total |
|---|---|---|---|
| Mean | 37.9 ± 14.07 | 38.0 ± 14.91 | 37.9 ± 14.47 |
| Sex: Female, Male(Participants) | Albuterol Spiromax | Placebo Spiromax | Total |
|---|---|---|---|
| Female | 105 | 122 | 227 |
| Male | 61 | 43 | 104 |
| Race/Ethnicity, Customized(participants) | Albuterol Spiromax | Placebo Spiromax | Total |
|---|---|---|---|
| White | 140 | 132 | 272 |
| Black | 19 | 28 | 47 |
| Asian | 4 | 1 | 5 |
| North American or Alaska Native | 1 | 0 | 1 |
| Other | 2 | 4 | 6 |
| Ethnicity(participants) | Albuterol Spiromax | Placebo Spiromax | Total |
|---|---|---|---|
| Hispanic | 20 | 21 | 41 |
| Not Hispanic | 146 | 144 | 290 |
| Height(inches) | Albuterol Spiromax | Placebo Spiromax | Total |
|---|---|---|---|
| Mean | 66.1 ± 3.59 | 65.7 ± 3.86 | 65.9 ± 3.73 |
| Weight(pounds) | Albuterol Spiromax | Placebo Spiromax | Total |
|---|---|---|---|
| Mean | 184 ± 49.7 | 179 ± 48.2 | 182 ± 48.9 |
This study is terminated, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Teva Branded Pharmaceutical Products R&D, Inc.