Phase 4
Completed N=1,976
Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety
Source: ClinicalTrials.gov NCT00359801 ↗Enrolled (actual)
1,976
Serious AEs
11.8%
Results posted
Jan 2010
Primary outcomePrimary: Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline — 100; 112; 81; 105 participants
Summary
The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of Exubera in routine clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline |
100; 112; 81; 105; 19; 7 | — |
| PRIMARY Supplemental Definition of Decline in Forced Expiratory Volume in One Second (FEV1): Number of Subjects |
100; 112; 62; 74; 38; 38 | — |
| PRIMARY Time to Persistent Decline in FEV1 Exceeding 20% From Baseline |
— | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in One Second (FEV1) |
2.661; 2.684; -0.009; -0.035; -0.032; -0.056 | — |
| SECONDARY Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis |
4; 1; 3; 2; 7; 3 | — |
| SECONDARY Time to Event for Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis |
— | — |
| SECONDARY All-cause Mortality: Number of Deaths |
12; 9 | — |
| SECONDARY Time to Event: All-cause Mortality |
— | — |
| SECONDARY Cardiovascular SAE Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke |
5; 3; 5; 6; 15; 9 | — |
| SECONDARY Time to Event for Cardiovascular Serious Adverse Event (SAE) Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction, or Non-fatal Stroke |
— | — |
| SECONDARY Allergic Response Serious Adverse Event (SAE) Composite: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm |
2; 0; 3; 0 | — |
| SECONDARY Time to Event for Allergic Response Serious Adverse Event (SAE) Composite, Including: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm |
— | — |
| SECONDARY Change in Glycosylated Hemoglobin (HbA1c) From Baseline |
— | — |
Eligibility Criteria
Inclusion Criteria
- Eligible for receiving Exubera treatment based on the approved local label
Exclusion Criteria
- Pregnant or lactating
- Have a progressive fatal disease or a life expectancy that prohibits them from participating in a five-year research study
Data sourced from ClinicalTrials.gov (NCT00359801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.