Trial · NCT01218009

A Twelve Month Long Term Safety Study to Evaluate the Safety of Albuterol in a Dry Powder Inhaler With Both Repeated and as Needed Dosing

NCT01218009, Phase 3, Terminated, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2015-05-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Twelve Month Long Term Safety Study to Evaluate the Safety of Albuterol in a Dry Powder Inhaler With Both Repeated and as Needed Dosing. Trials, record NCT01218009. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01218009

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Twelve Month Long Term Safety Study to Evaluate the Safety of Albuterol in a Dry Powder Inhaler With Both Repeated and as Needed Dosing
NCT number: NCT01218009
Status: Terminated
Phases: Phase 3
Enrollment: 331 participants, actual
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Conditions: Asthma
Interventions: Placebo Spiromax, Albuterol Spiromax
First posted: 2010-10-08
Last updated: 2015-05-20
Results first posted: 2015-05-20

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Participants With Treatment-Emergent Adverse Events	Day 1 to Day 49 (study termination)	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	Changes From Screening in the Results of the Physical Examination That Are Clinically Significant in the Opinion of the Investigator	Days -15 to -8 (Screening), Week 12, Week 52	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.
Primary	Changes From Screening in the Results of the Laboratory Evaluations That Are Clinically Significant in the Opinion of the Investigator	Days -15 to -8 (Screening), Week 12, Week 52	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.
Primary	Changes From Screening in the Results of the Electrocardiograms (ECGs) That Are Clinically Significant in the Opinion of the Investigator	Days -15 to -8 (Screening), Week 12, Week 52	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.
Primary	Changes From Screening in the Vital Signs That Are Clinically Significant in the Opinion of the Investigator	Days -15 to -8 (Screening), Week 12, Week 52	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.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Participants With Treatment-Emergent Adverse Events	Day 1 to Day 49 (study termination)	Safety population	participants	NUMBER
PRIMARY	Changes From Screening in the Results of the Physical Examination That Are Clinically Significant in the Opinion of the Investigator	Days -15 to -8 (Screening), Week 12, Week 52	Safety population. The study was terminated prior to the during study evaluations.
PRIMARY	Changes From Screening in the Results of the Laboratory Evaluations That Are Clinically Significant in the Opinion of the Investigator	Days -15 to -8 (Screening), Week 12, Week 52	Safety population. The study was terminated prior to the during study evaluations.
PRIMARY	Changes From Screening in the Results of the Electrocardiograms (ECGs) That Are Clinically Significant in the Opinion of the Investigator	Days -15 to -8 (Screening), Week 12, Week 52	Safety population. The study was terminated prior to the during study evaluations.
PRIMARY	Changes From Screening in the Vital Signs That Are Clinically Significant in the Opinion of the Investigator	Days -15 to -8 (Screening), Week 12, Week 52	Safety population. The study was terminated prior to the during study evaluations.
POST_HOC	Blood Pressure at Screening and End of Study	Days -15 to -8 (Screening), up to Day 49 (End of study)	Safety population	mmHg	MEAN
POST_HOC	Pulse at Screening and End of Study	Days -15 to -8 (Screening), up to Day 49 (End of study)	Safety population	beats/minute	MEAN

Source ClinicalTrials.gov

Results by group62

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Participants With Treatment-Emergent Adverse Events	Albuterol Spiromax	Any adverse event	59	participants
Participants With Treatment-Emergent Adverse Events	Placebo Spiromax	Any adverse event	58	participants
Participants With Treatment-Emergent Adverse Events	Albuterol Spiromax	Treatment-related adverse event	3	participants
Participants With Treatment-Emergent Adverse Events	Placebo Spiromax	Treatment-related adverse event	3	participants
Participants With Treatment-Emergent Adverse Events	Albuterol Spiromax	Withdrawn from study due to adverse event	0	participants
Participants With Treatment-Emergent Adverse Events	Placebo Spiromax	Withdrawn from study due to adverse event	0	participants
Participants With Treatment-Emergent Adverse Events	Albuterol Spiromax	Serious adverse event	1	participants
Participants With Treatment-Emergent Adverse Events	Placebo Spiromax	Serious adverse event	1	participants
Participants With Treatment-Emergent Adverse Events	Albuterol Spiromax	Treatment-related serious adverse event	0	participants
Participants With Treatment-Emergent Adverse Events	Placebo Spiromax	Treatment-related serious adverse event	0	participants

1 to 10 of 62Source ClinicalTrials.gov

See all 62 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Albuterol Spiromax	166
Overall Study	STARTED	Placebo Spiromax	165
Overall Study	COMPLETED	Albuterol Spiromax	0
Overall Study	COMPLETED	Placebo Spiromax	0
Overall Study	NOT COMPLETED	Albuterol Spiromax	166
Overall Study	NOT COMPLETED	Placebo Spiromax	165

Source ClinicalTrials.gov

Adverse events8

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
other	Nasopharyngitis	Infections and infestations	Albuterol Spiromax	6	166
other	Nasopharyngitis	Infections and infestations	Placebo Spiromax	10	165
other	Upper respiratory tract infection	Infections and infestations	Albuterol Spiromax	10	166
other	Upper respiratory tract infection	Infections and infestations	Placebo Spiromax	11	165
serious	Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Albuterol Spiromax	0	166
serious	Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Placebo Spiromax	1	165
serious	Asthma	Respiratory, thoracic and mediastinal disorders	Albuterol Spiromax	1	166
serious	Asthma	Respiratory, thoracic and mediastinal disorders	Placebo Spiromax	0	165

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Albuterol Spiromax
Total, all-cause mortality	Placebo Spiromax
Total, other adverse events	Albuterol Spiromax	16	166
Total, other adverse events	Placebo Spiromax	20	165
Total, serious adverse events	Albuterol Spiromax	1	166
Total, serious adverse events	Placebo Spiromax	1	165

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Albuterol Spiromax vs Placebo Spiromax: serious adverse events

Source Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01218009

GET https://conductscience.org/api/trials/v1/NCT01218009/results?page=2

API reference For AI assistants