Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127) (EOS)
This study has been completed.
Sponsor:
Takeda
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00313209
First received: April 11, 2006
Last updated: May 4, 2012
Last verified: April 2011
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Results First Received: March 17, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment |
| Condition: |
Chronic Obstructive Pulmonary Disease (COPD) |
| Interventions: |
Drug: Roflumilast Drug: Placebo |
Participant Flow
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Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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Reporting Groups
| Description | |
|---|---|
| Roflumilast | Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled |
| Placebo | Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled |
Participant Flow: Overall Study
| Roflumilast | Placebo | |
|---|---|---|
| STARTED | 466 [1] | 467 [1] |
| COMPLETED | 359 | 385 |
| NOT COMPLETED | 107 | 82 |
| [1] | Includes all randomized patients who took at least one dose of the investigational drug. |
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Baseline Characteristics
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Reporting Groups
| Description | |
|---|---|
| Roflumilast | Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled |
| Placebo | Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled |
| Total | Total of all reporting groups |
Baseline Measures
| Roflumilast | Placebo | Total | |
|---|---|---|---|
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Number of Participants
[units: participants] |
466 | 467 | 933 |
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Age
[units: years] Mean (Standard Deviation) |
64.9 (8.7) | 64.9 (9.3) | 64.9 (9.0) |
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Gender
[units: participants] |
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| Female | 147 | 168 | 315 |
| Male | 319 | 299 | 618 |
Outcome Measures
Show All Outcome Measures
| 1. Primary: | Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) [ Time Frame: Change from baseline over 24 weeks of treatment ] |
| 2. Secondary: | Post-bronchodilator FEV1 [ Time Frame: Change from baseline over 24 weeks of treatment ] |
| 3. Secondary: | COPD Exacerbation Rate (Mild, Moderate or Severe) [ Time Frame: 24 weeks treatment period ] |
| 4. Secondary: | Transition Dyspnea Index (TDI) Focal Score [ Time Frame: Change from baseline over 24 weeks of treatment ] |
| 5. Secondary: | Shortness of Breath Questionnaire (SOBQ) Total Score [ Time Frame: Change from baseline over 24 weeks of treatment ] |
Serious Adverse Events Other Adverse Events
| Time Frame | 24 weeks treatment period |
|---|---|
| Additional Description | The Safety Set was based on all randomized patients who took at least one dose of the investigational drug after randomization. |
Frequency Threshold
| Threshold above which other adverse events are reported | 5 |
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Reporting Groups
| Description | |
|---|---|
| Roflumilast | Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled |
| Placebo | Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled |
Other Adverse Events
| Roflumilast | Placebo | |
|---|---|---|
| Total, other (not including serious) adverse events | ||
| # participants affected / at risk | 165/466 (35.41%) | 143/467 (30.62%) |
| Gastrointestinal disorders | ||
| Diarrhoea † 1 [3] | ||
| # participants affected / at risk | 38/466 (8.15%) | 15/467 (3.21%) |
| # events | 41 | 16 |
| Nausea † 1 | ||
| # participants affected / at risk | 25/466 (5.36%) | 1/467 (0.21%) |
| # events | 26 | 1 |
| Infections and infestations | ||
| Nasopharyngitis † 1 | ||
| # participants affected / at risk | 33/466 (7.08%) | 35/467 (7.49%) |
| # events | 39 | 43 |
| Investigations | ||
| Weight decreased † 1 [3] | ||
| # participants affected / at risk | 39/466 (8.37%) | 5/467 (1.07%) |
| # events | 39 | 5 |
| Respiratory, thoracic and mediastinal disorders | ||
| Chronic obstructive pulmonary disease † 1 [3] | ||
| # participants affected / at risk | 70/466 (15.02%) | 103/467 (22.06%) |
| # events | 81 | 126 |
| † | Events were collected by systematic assessment |
|---|---|
| 1 | Term from vocabulary, MedDRA (11.0) |
| [3] | non-serious |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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