Trial · NCT00359801
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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 |
| SECONDARY | Time to Event for Allergic Response Serious Adverse Event (SAE) Composite, Including: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm | Baseline to 5 years | FAS. Due to early study termination, originally planned inferential analysis for time to event was not done. | days | NUMBER |
| SECONDARY | Change in Glycosylated Hemoglobin (HbA1c) From Baseline | Baseline, Month 6, Year 1, Year 2, Index Visit | FAS; (n) = number of subjects with analyzable data at observation for Exubera® and Non-Exubera®, respectively. | percent | MEAN |
| SECONDARY | Change in Glycosylated Hemoglobin (HbA1c) From Baseline | Baseline to 5 years | FAS. Due to early study termination, the originally planned inferential analysis (linear model) for change from baseline was not done. | percent | NUMBER |
| PRIMARY | Time to Persistent Decline in FEV1 Exceeding 20% From Baseline | Baseline to 5 years | FAS. Due to early study termination, originally planned inferential analysis for time to event was not done. | days | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00359801/outcomes