Trial · NCT00975195
Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease
NCT00975195, Phase 4, Completed, Boehringer Ingelheim; results first posted 2015-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease. Trials, record NCT00975195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00975195
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease
- NCT number
- NCT00975195
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,488 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- tiotropium inhalation, salmeterol xinafoate, fluticasone propionate, placebo matched for fluticasone propionate
- First posted
- 2009-09-11
- Last updated
- 2015-02-10
- Other registries' IDs
- eudract:2007-002522-29
- Results first posted
- 2015-02-10
- Limitations and caveats
Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab Full Text Review, section More Information.
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Moderate or Severe On-treatment COPD Exacerbation | During randomised treatment, up to 488 days | A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The "measure type" displays the 25th percentile and its 95% confidence interval. |
| Secondary | Number of Moderate or Severe On-treatment COPD Exacerbations | During randomised treatment, up to 488 days | Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids. Measured values show adjusted mean event rate. |
| Secondary | Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation | During randomised treatment, up to 488 days | Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids. |
| Secondary | Time to First Severe On-treatment COPD Exacerbation | During randomised treatment, up to 488 days | Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. The "measure type" displays the 25th percentile and its 95% confidence interval. |
| Secondary | Number of Severe On-treatment COPD Exacerbations | During randomised treatment, up to 488 days | Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Measured values show adjusted event rate. |
| Secondary | Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation. | During randomised treatment, up to 488 days | Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. |
| Secondary | Time to First On-treatment COPD Exacerbation | During randomised treatment, up to 488 days | Time to first on-treatment COPD exacerbation of any severity. The "measure type" displays the 25th percentile and its 95% confidence interval. |
| Secondary | Number of On-treatment COPD Exacerbations | During randomised treatment, up to 488 days | Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined. Measured values show adjusted event rate. |
| Secondary | Proportion of Patients With at Least One On-treatment COPD Exacerbation | During randomised treatment, up to 488 days | Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage. |
| Secondary | Severity of On-treatment COPD Exacerbations | During randomised treatment, up to 488 days | Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe) |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Moderate or Severe On-treatment COPD Exacerbation | During randomised treatment, up to 488 days | Treated set | days | NUMBER |
| SECONDARY | Number of Moderate or Severe On-treatment COPD Exacerbations | During randomised treatment, up to 488 days | Treated Set | exacerbations per patient-year | MEAN |
| SECONDARY | Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation | During randomised treatment, up to 488 days | Treated set | percentage of participants | NUMBER |
| SECONDARY | Time to First Severe On-treatment COPD Exacerbation | During randomised treatment, up to 488 days | Treated set | days | NUMBER |
| SECONDARY | Number of Severe On-treatment COPD Exacerbations | During randomised treatment, up to 488 days | Treated set | exacerbations per patient-year | MEAN |
| SECONDARY | Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation. | During randomised treatment, up to 488 days | Treated set | percentage of participants | NUMBER |
| SECONDARY | Time to First On-treatment COPD Exacerbation | During randomised treatment, up to 488 days | Treated set | days | NUMBER |
| SECONDARY | Number of On-treatment COPD Exacerbations | During randomised treatment, up to 488 days | Treated set | exacerbations per patient-year | MEAN |
| SECONDARY | Proportion of Patients With at Least One On-treatment COPD Exacerbation | During randomised treatment, up to 488 days | Treated set | percentage of participants | NUMBER |
| SECONDARY | Severity of On-treatment COPD Exacerbations | During randomised treatment, up to 488 days | Treated set | percentage of participants | NUMBER |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Moderate or Severe On-treatment COPD Exacerbation | Fluticasone Maintenance | 107.0 | 95% Confidence Interval 94.0 to 124.0 | days | |
| Time to First Moderate or Severe On-treatment COPD Exacerbation | Fluticasone Withdrawal | 110.0 | 95% Confidence Interval 99.0 to 120.0 | days | |
| Number of Moderate or Severe On-treatment COPD Exacerbations | Fluticasone Maintenance | 0.91 | 95% Confidence Interval 0.83 to 0.99 | exacerbations per patient-year | |
| Number of Moderate or Severe On-treatment COPD Exacerbations | Fluticasone Withdrawal | 0.95 | 95% Confidence Interval 0.87 to 1.04 | exacerbations per patient-year | |
| Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation | Fluticasone Maintenance | 44.2 | percentage of participants | ||
| Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation | Fluticasone Withdrawal | 46.7 | percentage of participants | ||
| Time to First Severe On-treatment COPD Exacerbation | Fluticasone Maintenance | NA | 95% Confidence Interval NA to NA | days | |
| Time to First Severe On-treatment COPD Exacerbation | Fluticasone Withdrawal | 419.0 | 95% Confidence Interval 379.0 to NA | days | |
| Number of Severe On-treatment COPD Exacerbations | Fluticasone Maintenance | 0.20 | 95% Confidence Interval 0.17 to 0.23 | exacerbations per patient-year | |
| Number of Severe On-treatment COPD Exacerbations | Fluticasone Withdrawal | 0.23 | 95% Confidence Interval 0.19 to 0.27 | exacerbations per patient-year |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fluticasone Maintenance | 1,244 | |
| Overall Study | STARTED | Fluticasone Withdrawal | 1,244 | |
| Overall Study | COMPLETED | Fluticasone Maintenance | 1,016 | |
| Overall Study | COMPLETED | Fluticasone Withdrawal | 1,011 | |
| Overall Study | NOT COMPLETED | Fluticasone Maintenance | 228 | |
| Overall Study | NOT COMPLETED | Fluticasone Withdrawal | 233 |
Source ClinicalTrials.gov
Adverse events562
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 | Nasopharyngitis | Infections and infestations | Fluticasone Maintenance | 93 | 1,243 | |
| other | Nasopharyngitis | Infections and infestations | Fluticasone Withdrawal | 80 | 1,242 | |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Fluticasone Maintenance | 410 | 1,243 | |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Fluticasone Withdrawal | 413 | 1,242 | |
| serious | Anaemia | Blood and lymphatic system disorders | Fluticasone Maintenance | 1 | 1,243 | |
| serious | Anaemia | Blood and lymphatic system disorders | Fluticasone Withdrawal | 0 | 1,242 | |
| serious | Anaemia macrocytic | Blood and lymphatic system disorders | Fluticasone Maintenance | 0 | 1,243 | |
| serious | Anaemia macrocytic | Blood and lymphatic system disorders | Fluticasone Withdrawal | 1 | 1,242 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Fluticasone Maintenance | 1 | 1,243 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Fluticasone Withdrawal | 0 | 1,242 |
1 to 10 of 562Source ClinicalTrials.gov
See all 562 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluticasone Maintenance | ||
| Total, all-cause mortality | Fluticasone Withdrawal | ||
| Total, other adverse events | Fluticasone Maintenance | 464 | 1,243 |
| Total, other adverse events | Fluticasone Withdrawal | 458 | 1,242 |
| Total, serious adverse events | Fluticasone Maintenance | 292 | 1,243 |
| Total, serious adverse events | Fluticasone Withdrawal | 300 | 1,242 |
Source ClinicalTrials.gov
Papers4
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Fluticasone Maintenance vs Fluticasone Withdrawal: 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.
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/NCT00975195
GET https://conductscience.org/api/trials/v1/NCT00975195/registered?page=2