Trial · NCT01698320
Safety Study of Albuterol Spiromax® in Subjects With Asthma
NCT01698320, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2015-08-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Study of Albuterol Spiromax® in Subjects With Asthma. Trials, record NCT01698320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01698320
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Albuterol Spiromax® in Subjects With Asthma
- NCT number
- NCT01698320
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 364 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Asthma
- Interventions
- Placebo MDPI, Albuterol MDPI
- First posted
- 2012-10-03
- Last updated
- 2015-08-19
- Results first posted
- 2015-08-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period) | Day 1 to Week 12 | 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. |
| Primary | Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period) | Weeks 13-52 | 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. |
| Primary | Electrocardiogram (ECG) Results At Weeks 0, 12, and 52 | Weeks 0 (screening visit), 12, and 52 | A standard 12-lead ECG was performed at screening, week 12, and week 52 or early termination/discontinuation. The ECG recording methods were centralized and standardized across all study participants. A centralized cardiologist was responsible for providing all ECG interpretations. |
| Primary | Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52 | Week 0, Week 12 and Week 52 | Participants were seated at least 2 minutes before blood pressure measurements were obtained by either an electronic or manual sphygmomanometer. Week 12 values represent change from Week 0. Week 52 values represent change from Week 12. |
| Primary | Change From Baseline in Pulse Measurements to Week 12 and Week 52 | Week 0, Week 12 and Week 52 | Participants were seated at least 2 minutes before pulse measurements were obtained by radial pulse. Week 12 values represent change from Week 0. Week 52 values represent change from Week 12. |
| Primary | Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52 | Weeks 0, 12 and 52 | The physical exam was performed by a qualified healthcare professional, and when possible, the same qualified healthcare professional that performed the physical examination at study screening performed all the scheduled physical examinations. Abnormalities and clinical relevance were determined by the qualified healthcare professional. HEENT = head, eyes, ears, nose, throat |
| Other | Composite Measurement of Device Ruggedness From Baseline to Week 52 | Baseline to Week 52 | Device Ruggedness: Reports of any problems/malfunction of the device (e.g., lack of efficacy, problems/malfunction after the device is dropped or sustains physical impact). |
| Other | Device Invitro Evaluations to Week 52 | Baseline to Week 52 | Device In Vitro Evaluations - All used study inhalers will be collected and a random selection of inhalers will be tested as follows: * Fifty (50) Albuterol Spiromax® inhalers used during weeks 0-12 will be randomly selected for in vitro testing * Fifty (50) Albuterol Spiromax® inhalers used during weeks 12-52 will be randomly selected for in vitro performance testing |
| Other | Daily AM Peak Expiratory Flow (PEF) to Week 52 | Baseline to Week 52 | Daily AM PEF will be recorded throughout the duration of the study to provide information on the subject's asthma status in order to assist in distinguishing between the use of back-up rescue medication related to an increased need for asthma symptom relief from that related to an issue with the Albuterol Spiromax® rescue inhaler. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period) | Day 1 to Week 12 | Safety population | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Composite Measurement of Device Ruggedness From Baseline to Week 52 | Baseline to Week 52 | |||
| OTHER_PRE_SPECIFIED | Device Invitro Evaluations to Week 52 | Baseline to Week 52 | |||
| OTHER_PRE_SPECIFIED | Daily AM Peak Expiratory Flow (PEF) to Week 52 | Baseline to Week 52 | |||
| PRIMARY | Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period) | Weeks 13-52 | Safety population | participants | NUMBER |
| PRIMARY | Electrocardiogram (ECG) Results At Weeks 0, 12, and 52 | Weeks 0 (screening visit), 12, and 52 | Safety population. Participants with assessments at each time point are reported. | participants | NUMBER |
| PRIMARY | Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52 | Week 0, Week 12 and Week 52 | Safety population. Participants with assessments at each time point are reported. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Pulse Measurements to Week 12 and Week 52 | Week 0, Week 12 and Week 52 | Safety population. Participants with assessments at each time point are reported. | beats/minute | MEAN |
| PRIMARY | Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52 | Weeks 0, 12 and 52 | Safety population. Participants with assessments at each time point are reported. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period) | Placebo MDPI-Albuterol MDPI | Any adverse event | 105 | participants | |
| Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period) | Albuterol MDPI-Albuterol MDPI | Any adverse event | 84 | participants | |
| Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period) | Placebo MDPI-Albuterol MDPI | Severe adverse event | 6 | participants | |
| Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period) | Albuterol MDPI-Albuterol MDPI | Severe adverse event | 3 | participants | |
| Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period) | Placebo MDPI-Albuterol MDPI | Treatment-related adverse event | 1 | participants | |
| Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period) | Albuterol MDPI-Albuterol MDPI | Treatment-related adverse event | 5 | participants | |
| Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period) | Placebo MDPI-Albuterol MDPI | Deaths | 0 | participants | |
| Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period) | Albuterol MDPI-Albuterol MDPI | Deaths | 0 | participants | |
| Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period) | Placebo MDPI-Albuterol MDPI | Other serious adverse events | 1 | participants | |
| Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period) | Albuterol MDPI-Albuterol MDPI | Other serious adverse events | 0 | participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-In Period (Week -1 to Day 0) | STARTED | All Enrolled Subjects | 364 | |
| Run-In Period (Week -1 to Day 0) | STARTED | Placebo MDPI-Albuterol MDPI | 0 | |
| Run-In Period (Week -1 to Day 0) | STARTED | Albuterol MDPI-Albuterol MDPI | 0 | |
| Run-In Period (Week -1 to Day 0) | COMPLETED | All Enrolled Subjects | 337 | |
| Run-In Period (Week -1 to Day 0) | COMPLETED | Placebo MDPI-Albuterol MDPI | 0 | |
| Run-In Period (Week -1 to Day 0) | COMPLETED | Albuterol MDPI-Albuterol MDPI | 0 | |
| Run-In Period (Week -1 to Day 0) | NOT COMPLETED | All Enrolled Subjects | 27 | |
| Run-In Period (Week -1 to Day 0) | NOT COMPLETED | Placebo MDPI-Albuterol MDPI | 0 | |
| Run-In Period (Week -1 to Day 0) | NOT COMPLETED | Albuterol MDPI-Albuterol MDPI | 0 | |
| 12-Week Double-Blind Period | STARTED | All Enrolled Subjects | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | Albuterol MDPI - Double-blind Period | 3 | 168 | 4 |
| other | Bronchitis | Infections and infestations | Placebo MDPI - Double-blind Period | 9 | 170 | 10 |
| other | Bronchitis | Infections and infestations | Albuterol MDPI (Formerly Placebo) - Open Label Period | 6 | 169 | 7 |
| other | Bronchitis | Infections and infestations | Albuterol MDPI (Formerly Albuterol) - Open Label Period | 6 | 168 | 6 |
| other | Influenza | Infections and infestations | Albuterol MDPI - Double-blind Period | 3 | 168 | 3 |
| other | Influenza | Infections and infestations | Placebo MDPI - Double-blind Period | 10 | 170 | 11 |
| other | Influenza | Infections and infestations | Albuterol MDPI (Formerly Placebo) - Open Label Period | 1 | 169 | 1 |
| other | Influenza | Infections and infestations | Albuterol MDPI (Formerly Albuterol) - Open Label Period | 2 | 168 | 2 |
| other | Nasopharyngitis | Infections and infestations | Albuterol MDPI - Double-blind Period | 10 | 168 | 12 |
| other | Nasopharyngitis | Infections and infestations | Placebo MDPI - Double-blind Period | 17 | 170 | 22 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Albuterol MDPI - Double-blind Period | ||
| Total, all-cause mortality | Placebo MDPI - Double-blind Period | ||
| Total, all-cause mortality | Albuterol MDPI (Formerly Placebo) - Open Label Period | ||
| Total, all-cause mortality | Albuterol MDPI (Formerly Albuterol) - Open Label Period | ||
| Total, other adverse events | Albuterol MDPI - Double-blind Period | 51 | 168 |
| Total, other adverse events | Placebo MDPI - Double-blind Period | 80 | 170 |
| Total, other adverse events | Albuterol MDPI (Formerly Placebo) - Open Label Period | 64 | 169 |
| Total, other adverse events | Albuterol MDPI (Formerly Albuterol) - Open Label Period | 67 | 168 |
| Total, serious adverse events | Albuterol MDPI - Double-blind Period | 0 | 168 |
| Total, serious adverse events | Placebo MDPI - Double-blind Period | 1 | 170 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26369589 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01698320
GET https://conductscience.org/api/trials/v1/NCT01698320/results?page=2