Trial · NCT00359801
Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety
NCT00359801, Phase 4, Completed, Pfizer; results first posted 2010-01-27
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ConductScience Library. Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety. Trials, record NCT00359801. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00359801
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety
- NCT number
- NCT00359801
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,976 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Diabetes Mellitus
- Interventions
- Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care, Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
- First posted
- 2006-08-02
- Last updated
- 2010-02-02
- Results first posted
- 2010-01-27
- Limitations and caveats
- Pursuant to Pfizer's announcement that it would exit marketing of Exubera®, study enrollment was halted on 26-October-2007.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline | Baseline, Month 6, Year 1, Year 2, Index Visit | Persistent decline in FEV1 exceeding 20% from baseline: observed decline in FEV1 exceeding 20% from baseline, 3 months after a confirmed decline (2 consecutive declines within 1 month) in FEV1 exceeding 20% from baseline. Second pulmonary function test (PFT) that confirmed decline was to occur within 14-42 days of the decline. Persistence: PFT that established persistence was to occur within 60-120 days of the confirming (2nd) decline. Index Visit: date subject had final Scheduled spirometry; was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment. |
| Primary | Supplemental Definition of Decline in Forced Expiratory Volume in One Second (FEV1): Number of Subjects | Baseline, Month 6, Year 1, Year 2, Index Visit | Confirmed FEV1 decline: any two consecutive declines that are \>= 14 days apart. The pulmonary function test that established persistence occured \>= 60 days after the initial decline. A confirmed decline: any two consecutive declines ≥ 14 days apart. The third PFT that established persistence was to occur ≥ 60 days after the initial decline. Index Visit: date the subject had his/her final scheduled spirometry was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment. |
| Primary | Time to Persistent Decline in FEV1 Exceeding 20% From Baseline | Baseline to 5 years | Elapsed time, in days, from the start of subject's participation in the study to the first reading of FEV1 that is: 20% or more below the subject's latest pre-study measurement, subsequently confirmed as a \>20% decline \[(baseline observed value minus visit observed value)/by baseline observed value \*100\], and assessed as persistent as defined by protocol process. Censoring time: elapsed time, in days, from the start of a subject's participation in the study to latest valid FEV1 measurement for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect. |
| Secondary | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline, Week 26, Week 52, Week 104, Index Visit | Change from Baseline: mean of value of observed forced expiratory volume in the first second of forced exhalation \[FEV1\] in liters \[L\] at observation minus Baseline value. Index Visit: date subject had final scheduled spirometry; was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment. |
| Secondary | Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis | Baseline through End of Study | Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria. Definite: definite pneumonia, definite COPD, or definite asthma; possible: possible pneumonia, possible COPD, possible asthma, probable obstructive lung disease not otherwise specified or probable acute bronchitis; definite or possible: either definite or possible; insufficient: insufficient data. |
| Secondary | Time to Event for Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis | Baseline to 5 years | Elapsed time, in days, from the start of a subject's participation in the study to the date of the first report of an event subsequently confirmed (according to protocol definition) as meeting the criteria for pulmonary SAE composite. Censoring time: elapsed time, in days, from the start of a subject's participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect. |
| Secondary | All-cause Mortality: Number of Deaths | Baseline through End of Study | Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria (confirmation of deaths by blinded adjudicator(s) through medical records or death certificates). Patients meeting the endpoint All Cause Mortality after adjudication by the endpoint committee. |
| Secondary | Time to Event: All-cause Mortality | Baseline to 5 years | Time to all-cause mortality: elapsed time, in days, from the start of a subject's participation in the study to the date of the event subsequently confirmed (according to protocol definition) as meeting the criteria for all-cause mortality. Censoring time: elapsed time, in days, from the start of a subject's participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect. |
| Secondary | Cardiovascular SAE Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke | Baseline through End of Study | Endpoint committee adjudicated based on review of medical/hospital records; results classified using standard criteria. Definite: definite MI or stroke; Possible: possible MI or stroke; Other (non-MI, non-stroke): other cardiovascular event (non-MI, non-stroke); Definite or possible: either definite or possible or both; Insufficient: insufficient data; Death from cardiovascular or cerebrovascular: cardiovascular or cerebrovascular event; Definite or possible or death from cardiovascular or cerebrovascular: either definite or possible or both or cardiovascular or cerebrovascular event. |
| Secondary | Time to Event for Cardiovascular Serious Adverse Event (SAE) Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction, or Non-fatal Stroke | Baseline to 5 years | Elapsed time, in days, from the start of a subject's participation in the study to the date of the first event subsequently confirmed (according to protocol definition) as meeting the criteria for cardiovascular SAE composite. Censoring time: elapsed time, in days, from the start of a subject's participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline | Baseline, Month 6, Year 1, Year 2, Index Visit | Full Analysis Set: all randomized subjects. | participants | NUMBER |
| SECONDARY | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline, Week 26, Week 52, Week 104, Index Visit | FAS; (n) = number of subjects with analyzable data at observation for Exubera® and Non-Exubera®, respectively. | liters | MEAN |
| SECONDARY | Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis | Baseline through End of Study | FAS | events | NUMBER |
| SECONDARY | Time to Event for Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis | Baseline to 5 years | FAS. Due to early study termination, originally planned inferential analysis for time to event was not done. | days | NUMBER |
| SECONDARY | All-cause Mortality: Number of Deaths | Baseline through End of Study | FAS | participants | NUMBER |
| SECONDARY | Time to Event: All-cause Mortality | Baseline to 5 years | FAS. Due to early study termination, originally planned inferential analysis for time to event was not done. | days | NUMBER |
| PRIMARY | Supplemental Definition of Decline in Forced Expiratory Volume in One Second (FEV1): Number of Subjects | Baseline, Month 6, Year 1, Year 2, Index Visit | FAS | participants | NUMBER |
| SECONDARY | Cardiovascular SAE Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke | Baseline through End of Study | FAS | events | NUMBER |
| SECONDARY | Time to Event for Cardiovascular Serious Adverse Event (SAE) Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction, or Non-fatal Stroke | Baseline to 5 years | FAS. Due to early study termination, originally planned inferential analysis for time to event was not done. | days | NUMBER |
| SECONDARY | Allergic Response Serious Adverse Event (SAE) Composite: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm | Baseline through End of Study | FAS | events | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline | Exubera® | Initial FEV1 Decline | 100 | participants | |
| Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline | Non-Exubera® | Initial FEV1 Decline | 112 | participants | |
| Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline | Exubera® | Initial FEV1 Decline but not a Confirmed Decline | 81 | participants | |
| Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline | Non-Exubera® | Initial FEV1 Decline but not a Confirmed Decline | 105 | participants | |
| Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline | Exubera® | Confirmed FEV1 Decline | 19 | participants | |
| Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline | Non-Exubera® | Confirmed FEV1 Decline | 7 | participants | |
| Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline | Exubera® | Confirmed FEV1 Decline but not Persistent Decline | 11 | participants | |
| Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline | Non-Exubera® | Confirmed FEV1 Decline but not Persistent Decline | 7 | participants | |
| Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline | Exubera® | Persistent FEV1 Decline | 8 | participants | |
| Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline | Non-Exubera® | Persistent FEV1 Decline | 0 | participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Exubera® | 987 | |
| Overall Study | STARTED | Non-Exubera® | 989 | |
| Overall Study | COMPLETED | Exubera® | 682 | |
| Overall Study | COMPLETED | Non-Exubera® | 769 | |
| Overall Study | NOT COMPLETED | Exubera® | 305 | |
| Overall Study | NOT COMPLETED | Non-Exubera® | 220 |
Source ClinicalTrials.gov
Adverse events520
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 | Angina pectoris | Cardiac disorders | Exubera® | 1 | 987 | |
| other | Angina pectoris | Cardiac disorders | Non-Exubera® | 0 | 989 | |
| other | Vision blurred | Eye disorders | Exubera® | 1 | 987 | |
| other | Vision blurred | Eye disorders | Non-Exubera® | 0 | 989 | |
| other | Gingival pain | Gastrointestinal disorders | Exubera® | 1 | 987 | |
| other | Gingival pain | Gastrointestinal disorders | Non-Exubera® | 0 | 989 | |
| other | Nausea | Gastrointestinal disorders | Exubera® | 0 | 987 | |
| other | Nausea | Gastrointestinal disorders | Non-Exubera® | 1 | 989 | |
| other | Adverse drug reaction | General disorders | Exubera® | 1 | 987 | |
| other | Adverse drug reaction | General disorders | Non-Exubera® | 0 | 989 |
1 to 10 of 520Source ClinicalTrials.gov
See all 520 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Exubera® | ||
| Total, all-cause mortality | Non-Exubera® | ||
| Total, other adverse events | Exubera® | 26 | 987 |
| Total, other adverse events | Non-Exubera® | 11 | 989 |
| Total, serious adverse events | Exubera® | 124 | 987 |
| Total, serious adverse events | Non-Exubera® | 109 | 989 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Exubera® vs Non-Exubera®: All-cause Mortality: Number of Deaths | Trial comparisons |
| Exubera® vs Non-Exubera®: serious adverse events | 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.
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.
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