Pulmonary Disease, Chronic ObstructivePhase 4NCT01607398
ADOAIR250 Anti-inflammatory Effects in Japanese Subjects With Chronic Obstructive Pulmonary Disease
A Phase 4 study testing ADOAIR250 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 3 sites in Japan.
Trial summary
The study will be conducted in a respiratory specialist institute in Japan, with standardized techniques and data assurance checks to optimize data quality. The licensed dosage and administration of Adoair in Japan will be applied in this study. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- ADOAIR250
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 3 sitesJapan
- Study dates
- May 2012to Jul 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese (male or female) outpatients aged 40-80 years inclusive at Visit 1 (Female patients may be enrolled only if they are not of child-bearing potential, or are of child-bearing potential who agree to properly use protocol-specified contraceptive measures. )
- Have a diagnosis of COPD (defined as per the COPD guideline)
- Have a FEV1/FVC ratio < 0.70 at 15-60 minutes following use of SALTANOL® INHALER
- Have a FEV1 of >= 40% to < 80% of the predicted normal value at 15-60 minutes following use of SALTANOL® INHALER
- Current or ex-smokers with a smoking history of at least 10 pack-years
- Able to use the DISKUS inhaler and the short-acting inhaled anticholinergic drug
- Capable of providing written voluntary consent to participate in the study
Who cannot join
- Diagnosed by the investigator (or subinvestigator) as having bronchial asthma
- Have any respiratory disorder other than COPD (e.g., lung cancer, sarcoidosis, tuberculosis [including old tuberculosis], pulmonary fibrosis)
- Have a chest X-ray (or CT scan) indicating a diagnosis other than COPD that might interfere with assessments in the study (This must be assessed using last imaging study performed within 6 months prior to Visit 1; or, a chest X-ray must be obtained at Visit 1.)
- Have chronic respiratory failure
- Have undergone lung volume reduction and/or lung transplant
- Have had a COPD exacerbation or respiratory infection requiring systemic corticosteroid or microbial therapy or hospitalisation, within 6 weeks prior to Visit 1
Show all 18Show fewer
- Have used inhaled corticosteroids and systemic corticosteroids within 4 weeks prior to Visit 1
- Have used long-acting β2 agonists (inhaled or patch) within 2 weeks prior to Visit 1
- Are unable to stop their short-acting β2 agonist therapy at Visit 1 (During the study participation, oxitropium bromide (TERSIGAN) will be used as relief medication.)
- Receiving long-term oxygen therapy with oxygen use for more than 12 hours per day
- Have a concurrent serious or uncontrolled disease that might interfere with assessments in the study (including psychiatric disease, unstable liver disease, and heart disease)
- Have a QTc > 450 msec (or > 480 msec in patients with bundle branch block) at Visit 1 (based on average QTc from three consecutive cardiac cycles on ECG)
- Have participated in another study and received any other study drug within 4 weeks prior to Visit 1
- Diagnosed by the investigator (or subinvestigator) as having drug or alcohol dependence
- Have known or suspected hypersensitivity to bronchodilators, inhaled corticosteroid, or lactose
- Have known α1 antitrypsin deficiency
- Previously enrolled in this study
- Judged by the investigator (or subinvestigator) to be inappropriate to participate in this study
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
GSK Investigational Site
Osaka, 530-0001
GSK Investigational Site
Osaka, 545-8586
GSK Investigational Site
Osaka, 559-0011
About this study
Official title: A 12-week Randomised, Double-blind, Parallel-group Study to Evaluate the Anti-inflammatory Effects of ADOAIR® 50/250mcg Twice Daily Compared With Placebo Twice Daily in Japanese Subjects With Chronic Obstructive Pulmonary Disease (COPD)
The study will be conducted in a respiratory specialist institute in Japan, with standardized techniques and data assurance checks to optimize data quality. The licensed dosage and administration of Adoair in Japan will be applied in this study. Each subject will receive treatment options in a randomized blinded fashion. Subjects will be randomized following a 4-week wash-out phase to take either Adoair 50/250mcg twice daily or placebo twice daily for 12 weeks.
Read the detailed description
This is a randomised, double-blind, placebo-controlled, two-arm, parallel-group, 12-week-treatment study in Japanese patients with COPD.
At Visit 1, patients confirmed to be fulfilling all the inclusion criteria and not meeting any of the exclusion criteria will start the 4-week run-in period. During the entire study period, including the run-in period, the only drug allowed to use in addition to the study drug will be oxitropium (short-acting anticholinergic drug) as relief medication. At the end of the run-in period (Visit 2), subjects eligible for randomisation will be evenly randomised to one of the following two treatment groups and start the 12-week treatment period.
- ADOAIR®250 one inhalation twice daily from the DISKUS inhaler
- Placebo one inhalation twice daily from the DISKUS inhaler
Study completers will be defined as subjects who have completed all examinations, assessments, and study procedures in the study period, including the run-in period and the follow-up period. At completion/discontinuation of the treatment period, subjects will be switched to appropriate COPD treatment at the discretion of the investigator (or subinvestigator).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- ADOAIR250, Placebo
- Keywords
- Japan, COPD, CAT, placebo, serum, Adoair250, anti-inflammatory, sputum
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADOAIR250Drug
250 mcg inhalation, twice daily, from week0 -12.
PlaceboDrug
Placebo inhalation, twice daily, from week0 -12.
| Study group | Role | What they receive |
|---|---|---|
| ADOAIR250 | Experimental | ADOAIR 250mcg inhalations, twice daily, from week0 - 12 Receives: Drug: ADOAIR250 |
| Placebo | Placebo comparator | Placebo inhalation, twice daily, from week0 -12 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Neutrophil Count in Induced Sputum at Week 12
Induced sputum samples were collected at Baseline and at Week 12. The neutrophil count in induced sputum was measured with the use of a cytological specimen of inflammatory cells in the induced sputum. Change from Baseline in neutrophil count was calculated as the Week 12 value minus the Baseline value (percentage of neutrophil of total cells in induced sputum at Week 12 minus the Baseline value).
Measured: Baseline and Week 12
Secondary outcomes (19)
Change From Baseline in All Inflammatory Cell Count in Induced Sputum at Week 12
Induced sputum samples were collected at Baseline and at Week 12. All inflammatory cells in induced sputum were counted with the use of a cytological specimen of cells in the induced sputum. Change from Baseline in all inflammatory cell count was calculated as the Week 12 value minus the Baseline value.
Measured: Baseline and Week 12
Change From Baseline in Interferon (INF)-Gamma-positive Cells and Perforin-positive Cells in Sputum at Week 12
INF-gamma-positive cells and perforin-positive cells were not detected in samples collected in this study due to the conditions of the samples and/or antibodies. No re-assays were performed, "no result"/"no data" was entered into the case report forms, and no statistical analysis or data summarization was performed.
Measured: Baseline and Week 12
Change From Baseline in Interleukin (IL)-8 Levels in Sputum Supernatant at Week 12
Induced sputum samples were collected at Baseline and at Week 12. The levels of IL-8 in the supernatant of an induced sputum sample were measured at the same time using the multiplex assay system. Change from Baseline in IL-8 levels was calculated as the Week 12 value minus the Baseline value.
Measured: Baseline and Week 12
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Levels in Sputum Supernatant at Week 12
Data cannot be reported because hsCRP was under the lower limit of detection in all samples.
Measured: Baseline and Week 12
Change From Baseline in Myeloperoxidase (MPO) and Pulmonary Surfactant Protein (SP)-D Levels in Sputum Supernatant at Week 12
Induced sputum samples were collected at Baseline and at Week 12. The levels of MPO and SP-D in the supernatant of an induced sputum sample were measured at the same time using the multiplex assay system. Change from Baseline in MPO and SP-D levels was calculated as the Week 12 value minus the Baseline value.
Measured: Baseline and Week 12
Change From Baseline in IL-6 and IL-8 Levels in Serum at Week 12
Serum samples were collected at Baseline and at Week 12. The levels of IL-6 and IL-8 in serum samples were measured at the same time using the multiplex assay system. Change from Baseline in IL-6 and IL-8 levels was calculated as the Week 12 value minus the Baseline value.
Measured: Baseline and Week 12
Change From Baseline in hsCRP, SP-D, and Clara Cell Protein 16 (CC 16) Levels in Serum at Week 12
Serum samples were collected at Baseline and at Week 12. The levels of hsCRP, SP-D, and CC16 in serum samples were measured at the same time using the multiplex assay system. Change from Baseline in hsCRP, SP-D, and CC16 was calculated as the Week 12 value minus the Baseline value.
Measured: Baseline and Week 12
Change From Baseline in Fibrinogen Levels in Serum at Week 12
Per Protocol Amendment 4, the measurement of fibrinogen levels in serum was removed from the analysis plan because fibrinogen levels were found to be too low and too difficult to measure.
Measured: Baseline and Week 12
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Week 12
FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Respiratory function tests were performed for the measurement of FEV1 and FVC at Baseline and at Week 12. The values were measured at 15 to 60 minutes following the use of a pressurized metered-dose inhaler. Three technically acceptable values were obtained, and the highest value was recorded. Change from Baseline in FEV1 and FVC was calculated as the Week 12 value minus the Baseline value.
Measured: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 1 Score at Week 12
Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 1, participants were asked to rate how much they cough on a scale of 0 to 5: 0, "I never cough"; 5, "I cough all the time." Change from Baseline was calculated as the Week 12 score minus the Baseline score.
Measured: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 2 Score at Week 12
Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 2, participants were asked to rate the amount of phlegm (mucus) in their chest on a scale of 0 to 5: 0, "I have no phlegm (mucus) in my chest at all"; 5, "My chest is completely full of phlegm (mucus)." Change from Baseline was calculated as the Week 12 score minus the Baseline score.
Measured: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 3 Score at Week 12
Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 3, participants were asked to rate how tight their chest feels on a scale of 0 to 5: 0, "My chest does not feel tight at all"; 5, "My chest feels very tight." Change from Baseline was calculated as the Week 12 score minus the Baseline score.
Measured: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 4 Score at Week 12
Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 4, participants were asked to rate how breathless they feel when walking up a flight of stairs or a hill on a scale of 0 to 5: 0, "When I walk up a hill or one flight of stairs I am not breathless"; 5, "When I walk up a hill or one flight of stairs I am very breathless." Change from Baseline was calculated as the Week 12 score minus the Baseline score.
Measured: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 5 Score at Week 12
Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 5, participants were asked to rate how limited they are in doing activities at home on a scale of 0 to 5: 0, "I am not limited doing any activities at home"; 5, "I am very limited doing activities at home." Change from Baseline was calculated as the Week 12 score minus the Baseline score.
Measured: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 6 Score at Week 12
Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 6, participants were asked to rate how confident they are leaving home despite their lung condition on a scale of 0 to 5: 0, "I am confident leaving my home despite my lung condition"; 5, "I am not at all confident leaving my home because of my lung condition." Change from Baseline was calculated as the Week 12 score minus the Baseline score.
Measured: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 7 Score at Week 12
Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 7, participants were asked to rate how soundly they sleep on a scale of 0 to 5: 0, "I sleep soundly"; 5, "I don't sleep soundly because of my lung condition." Change from Baseline was calculated as the Week 12 score minus the Baseline score.
Measured: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 8 Score at Week 12
Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 8, participants were asked to rate how much energy they have on a scale of 0 to 5: 0, "I have lots of energy"; 5, "I have no energy at all." Change from Baseline was calculated as the Week 12 score minus the Baseline score.
Measured: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Total Score at Week 12
Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8; each question scored from 0 to 5) designed to assess the health status of participants with COPD. The total score is calculated as the sum of the scores from Questions 1 to 8, for a range of possible scores of 0 to 40. A higher total score represents a lower quality of life, and vice versa. Change from Baseline was calculated as the Week 12 score minus the Baseline score.
Measured: Baseline and Week 12
Number of Participants Who Experienced the Indicated Number of COPD Exacerbations During the Treatment Period
The occurrence of a COPD exacerbation was assessed on each day of evaluation during the treatment period per the defined severity classifications. COPD exacerbations were classified based on severity as a mild exacerbation (exacerbation of COPD symptoms were manageable by the participant, not requiring systemic corticosteroid or antimicrobial therapy), a moderate exacerbation (exacerbation of COPD symptoms required systemic corticosteroid or antimicrobial therapy), or a severe exacerbation (exacerbation of COPD symptoms required hospitalization). The number of participants who experienced 0, 1, 2, and >=3 exacerbation(s) was summarized.
Measured: From Baseline up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607398
- Sponsor's protocol ID
- 116571
- Status last verified
- Mar 2014
- First submitted
- 10 May 2012
- Last updated
- 26 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Asai K, Kobayashi A, Makihara Y, Johnson M. Anti-inflammatory effects of salmeterol/fluticasone propionate 50/250 mcg combination therapy in Japanese patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2015 Apr 17;10:803-11. doi: 10.2147/COPD.S79842. eCollection 2015.
PubMed 25945045
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Randomised, Double-blind, Parallel-group Study to Evaluate the Anti-inflammatory Effects of ADOAIR® 50/250mcg Twice Daily Compared With Placebo Twice Daily in Japanese Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01607398
- Acronym / sponsor ID
- 116571
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Japan, COPD, CAT, placebo, serum, Adoair250, anti-inflammatory, sputum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 May 2012 (estimated)
- Results
- Posted 26 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be conducted in a respiratory specialist institute in Japan, with standardized techniques and data assurance checks to optimize data quality. The licensed dosage and administration of Adoair in Japan will be applied in this study. Each subject will receive treatment options in a randomized blinded fashion. Subjects will be randomized following a 4-week wash-out phase to take either Adoair 50/250mcg twice daily or placebo twice daily for 12 weeks.
Detailed description
This is a randomised, double-blind, placebo-controlled, two-arm, parallel-group, 12-week-treatment study in Japanese patients with COPD.
At Visit 1, patients confirmed to be fulfilling all the inclusion criteria and not meeting any of the exclusion criteria will start the 4-week run-in period. During the entire study period, including the run-in period, the only drug allowed to use in addition to the study drug will be oxitropium (short-acting anticholinergic drug) as relief medication. At the end of the run-in period (Visit 2), subjects eligible for randomisation will be evenly randomised to one of the following two treatment groups and start the 12-week treatment period.
- ADOAIR®250 one inhalation twice daily from the DISKUS inhaler
- Placebo one inhalation twice daily from the DISKUS inhaler
Study completers will be defined as subjects who have completed all examinations, assessments, and study procedures in the study period, including the run-in period and the follow-up period. At completion/discontinuation of the treatment period, subjects will be switched to appropriate COPD treatment at the discretion of the investigator (or subinvestigator).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADOAIR250 | Experimental | Drug: ADOAIR250ADOAIR 250mcg inhalations, twice daily, from week0 - 12 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo inhalation, twice daily, from week0 -12 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Japanese (male or female) outpatients aged 40-80 years inclusive at Visit 1 (Female patients may be enrolled only if they are not of child-bearing potential, or are of child-bearing potential who agree to properly use protocol-specified contraceptive measures. )
- Have a diagnosis of COPD (defined as per the COPD guideline)
- Have a FEV1/FVC ratio < 0.70 at 15-60 minutes following use of SALTANOL® INHALER
- Have a FEV1 of >= 40% to < 80% of the predicted normal value at 15-60 minutes following use of SALTANOL® INHALER
- Current or ex-smokers with a smoking history of at least 10 pack-years
Key exclusion criteria (18 listed)
- Diagnosed by the investigator (or subinvestigator) as having bronchial asthma
- Have any respiratory disorder other than COPD (e.g., lung cancer, sarcoidosis, tuberculosis [including old tuberculosis], pulmonary fibrosis)
- Have a chest X-ray (or CT scan) indicating a diagnosis other than COPD that might interfere with assessments in the study (This must be assessed using last imaging study performed within 6 months prior to Visit 1; or, a chest X-ray must be obtained at Visit 1.)
- Have chronic respiratory failure
- Have undergone lung volume reduction and/or lung transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADOAIR250250 mcg inhalation, twice daily, from week0 -12. | Drug | ADOAIR250 |
| PlaceboPlacebo inhalation, twice daily, from week0 -12. | Drug | Placebo |
Primary outcome
Change From Baseline in Neutrophil Count in Induced Sputum at Week 12
Time frame: Baseline and Week 12
Induced sputum samples were collected at Baseline and at Week 12. The neutrophil count in induced sputum was measured with the use of a cytological specimen of inflammatory cells in the induced sputum. Change from Baseline in neutrophil count was calculated as the Week 12 value minus the Baseline value (percentage of neutrophil of total cells in induced sputum at Week 12 minus the Baseline value).
19 secondary outcomes
Change From Baseline in All Inflammatory Cell Count in Induced Sputum at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Interferon (INF)-Gamma-positive Cells and Perforin-positive Cells in Sputum at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Interleukin (IL)-8 Levels in Sputum Supernatant at Week 12
Time frame: Baseline and Week 12
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Levels in Sputum Supernatant at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Myeloperoxidase (MPO) and Pulmonary Surfactant Protein (SP)-D Levels in Sputum Supernatant at Week 12
Time frame: Baseline and Week 12
Change From Baseline in IL-6 and IL-8 Levels in Serum at Week 12
Time frame: Baseline and Week 12
Change From Baseline in hsCRP, SP-D, and Clara Cell Protein 16 (CC 16) Levels in Serum at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Fibrinogen Levels in Serum at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 1 Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 2 Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 3 Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 4 Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 5 Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 6 Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 7 Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Question 8 Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in the COPD Assessment Test (CAT) Total Score at Week 12
Time frame: Baseline and Week 12
Number of Participants Who Experienced the Indicated Number of COPD Exacerbations During the Treatment Period
Time frame: From Baseline up to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25945045Asai K, Kobayashi A, Makihara Y, Johnson M. Anti-inflammatory effects of salmeterol/fluticasone propionate 50/250 mcg combination therapy in Japanese patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2015 Apr 17;10:803-11. doi: 10.2147/COPD.S79842. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ADOAIR250 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Neutrophil Count in Induced Sputum at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01607398, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2014.