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Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD9668
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic, obstructive, pulmonary, lung, respiratory disease, efficacy, placebo-controlled, COPD, FEV1, St Georges Respiratory Questionnaire

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of COPD with symptoms over 1 year
  • FEV1/FVC < 70% and FEV1 >= 30 and < 80 % of predicted post-bronchodilator
  • Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation
  • At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit

Exclusion Criteria:

  • Past history or current evidence of clinically significant heart disease
  • Current diagnosis of asthma
  • Patients who require long term oxygen therapy
  • Worsening of COPD requiring treatment with antibiotics, an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Baseline Pre-bronchodilator FEV1 (L)
Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
End-value Pre-bronchodilator FEV1 (L)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

Secondary Outcome Measures

Post-bronchodilator FEV1 (L) - Baseline
Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Post-bronchodilator FEV1 (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Pre-bronchodilator FVC (L) - Baseline
Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Pre-bronchodilator FVC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Post-bronchodilator FVC (L) - Baseline
Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Post-bronchodilator FVC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Baseline Pre-bronchodilator FEV6 (L)
Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
End-value Pre-bronchodilator FEV6 (L)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Baseline Post-bronchodilator FEV6 (L)
Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured post after bronchodilator (salbutamol) use in the clinic.
End-value Post-bronchodilator FEV6 (L)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Baseline Pre-bronchodilator FEF25-75% (L/Sec)
Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
End-value Pre-bronchodilator FEF25-75% (L/Sec)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Baseline Post-bronchodilator FEF25-75% (L/Sec)
Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
End-value Post-bronchodilator FEF25-75% (L/Sec)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Pre-bronchodilator IC (L) - Baseline
Inspiratory capacity (IC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Pre-bronchodilator IC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Post-bronchodilator IC (L) - Baseline
Inspiratory capacity (IC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Post-bronchodilator IC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
PEF - Baseline Measured by Patient at Home (L/Min) in the Morning
Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning. Baseline is the mean of last 10 days of data before start of treatment.
PEF - End-value Measured by Patient at Home (L/Min) in the Morning
Peak expiratory flow (PEF)
FEV1 - Baseline Measured by Patient at Home (L) in the Morning
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning. Baseline is the mean of last 10 days of data before start of treatment.
FEV1 - End-value Measured by Patient at Home (L) in the Morning
Forced Expiratory Volume in 1 second (L)
EXACT - Baseline Total Score
EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale). Baseline is the mean of last 10 days of data before start of treatment.
EXACT - End-value Total Score
EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale).
BCSS - Baseline Total Score
Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale). Baseline is the mean of last 10 days of data before start of treatment.
BCSS - End-value Total Score
Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale).
Sputum Colour - Baseline
Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).
Sputum Colour - End Value
Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status). End of treatment week 12
Use of Reliever Medication
Daily average of number of inhalations of reliever medication
Incremental Shuttle Walk Test - Baseline
Endurance time (s)
Incremental Shuttle Walk Test - End Value
Endurance Shuttle Walk Test - Baseline
Endurance time (s)
Endurance Shuttle Walk Test - End Value
Assessed at vist 6 -( last on treatment clinic visit)
St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline
St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a scale from 0 (best health status) to 100(worst possible status)).
St George's Respiratory Questionnaire (COPD) - End-value Overall Score
St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a scale from 0 (best health status) to 100(worst possible status)).Questionaire assessed on vist 6 -( last on treatment clinic visit)
Exacerbations - Clinic Defined
Number of patients having a clinic defined disease exacerbation.

Full Information

First Posted
December 1, 2009
Last Updated
June 19, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01023516
Brief Title
Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol
Official Title
A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multinational, Phase IIb Study to Evaluate the Efficacy and Safety of 60mg AZD9668 Administered Orally Twice Daily to Subjects With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Budesonide/Formoterol
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic, obstructive, pulmonary, lung, respiratory disease, efficacy, placebo-controlled, COPD, FEV1, St Georges Respiratory Questionnaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
615 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD9668
Intervention Description
2 x 30 mg oral tablets bd for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 x matched placebo to oral tablet bd for 12 weeks
Primary Outcome Measure Information:
Title
Baseline Pre-bronchodilator FEV1 (L)
Description
Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Time Frame
Day 1
Title
End-value Pre-bronchodilator FEV1 (L)
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
up to week 12
Secondary Outcome Measure Information:
Title
Post-bronchodilator FEV1 (L) - Baseline
Description
Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Time Frame
Day 1
Title
Post-bronchodilator FEV1 (L) - End-value
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
up to week 12
Title
Pre-bronchodilator FVC (L) - Baseline
Description
Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Time Frame
Day 1
Title
Pre-bronchodilator FVC (L) - End-value
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
up to week 12
Title
Post-bronchodilator FVC (L) - Baseline
Description
Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Time Frame
Day 1
Title
Post-bronchodilator FVC (L) - End-value
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
up to week 12
Title
Baseline Pre-bronchodilator FEV6 (L)
Description
Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Time Frame
Day 1
Title
End-value Pre-bronchodilator FEV6 (L)
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
up to week 12
Title
Baseline Post-bronchodilator FEV6 (L)
Description
Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured post after bronchodilator (salbutamol) use in the clinic.
Time Frame
Day 1
Title
End-value Post-bronchodilator FEV6 (L)
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
up to week 12
Title
Baseline Pre-bronchodilator FEF25-75% (L/Sec)
Description
Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Time Frame
Day 1
Title
End-value Pre-bronchodilator FEF25-75% (L/Sec)
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
up to week 12
Title
Baseline Post-bronchodilator FEF25-75% (L/Sec)
Description
Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Time Frame
Day 1
Title
End-value Post-bronchodilator FEF25-75% (L/Sec)
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
up to week 12
Title
Pre-bronchodilator IC (L) - Baseline
Description
Inspiratory capacity (IC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Time Frame
Day 1
Title
Pre-bronchodilator IC (L) - End-value
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
up to week 12
Title
Post-bronchodilator IC (L) - Baseline
Description
Inspiratory capacity (IC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Time Frame
Day 1
Title
Post-bronchodilator IC (L) - End-value
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
up to week 12
Title
PEF - Baseline Measured by Patient at Home (L/Min) in the Morning
Description
Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning. Baseline is the mean of last 10 days of data before start of treatment.
Time Frame
Baseline
Title
PEF - End-value Measured by Patient at Home (L/Min) in the Morning
Description
Peak expiratory flow (PEF)
Time Frame
Last 6 weeks on treatment
Title
FEV1 - Baseline Measured by Patient at Home (L) in the Morning
Description
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning. Baseline is the mean of last 10 days of data before start of treatment.
Time Frame
Baseline
Title
FEV1 - End-value Measured by Patient at Home (L) in the Morning
Description
Forced Expiratory Volume in 1 second (L)
Time Frame
Last 6 weeks on treatment
Title
EXACT - Baseline Total Score
Description
EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale). Baseline is the mean of last 10 days of data before start of treatment.
Time Frame
Baseline
Title
EXACT - End-value Total Score
Description
EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale).
Time Frame
Last 6 weeks on treatment
Title
BCSS - Baseline Total Score
Description
Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale). Baseline is the mean of last 10 days of data before start of treatment.
Time Frame
Baseline
Title
BCSS - End-value Total Score
Description
Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale).
Time Frame
Last 6 weeks on treatment
Title
Sputum Colour - Baseline
Description
Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).
Time Frame
Baseline
Title
Sputum Colour - End Value
Description
Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status). End of treatment week 12
Time Frame
End of treatment week 12
Title
Use of Reliever Medication
Description
Daily average of number of inhalations of reliever medication
Time Frame
Last 6 weeks on treatment
Title
Incremental Shuttle Walk Test - Baseline
Description
Endurance time (s)
Time Frame
Day 1
Title
Incremental Shuttle Walk Test - End Value
Time Frame
Week 12 - visit 6
Title
Endurance Shuttle Walk Test - Baseline
Description
Endurance time (s)
Time Frame
Day 1
Title
Endurance Shuttle Walk Test - End Value
Description
Assessed at vist 6 -( last on treatment clinic visit)
Time Frame
Week 12 - visit 6
Title
St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline
Description
St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a scale from 0 (best health status) to 100(worst possible status)).
Time Frame
Day 1
Title
St George's Respiratory Questionnaire (COPD) - End-value Overall Score
Description
St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a scale from 0 (best health status) to 100(worst possible status)).Questionaire assessed on vist 6 -( last on treatment clinic visit)
Time Frame
Measured Day 1 and 12 weeks
Title
Exacerbations - Clinic Defined
Description
Number of patients having a clinic defined disease exacerbation.
Time Frame
Duration of the the treatment period - 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of COPD with symptoms over 1 year FEV1/FVC < 70% and FEV1 >= 30 and < 80 % of predicted post-bronchodilator Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit Exclusion Criteria: Past history or current evidence of clinically significant heart disease Current diagnosis of asthma Patients who require long term oxygen therapy Worsening of COPD requiring treatment with antibiotics, an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Kuna, Professor
Organizational Affiliation
Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Lovech
Country
Bulgaria
Facility Name
Research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
Country
Bulgaria
Facility Name
Research Site
City
Russe
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Stara Zagora
Country
Bulgaria
Facility Name
Research Site
City
Troyan
Country
Bulgaria
Facility Name
Research Site
City
Varna
Country
Bulgaria
Facility Name
Research Site
City
Jihlava
Country
Czech Republic
Facility Name
Research Site
City
Jindrichuv Hradec
Country
Czech Republic
Facility Name
Research Site
City
Kladno
Country
Czech Republic
Facility Name
Research Site
City
Krnov
Country
Czech Republic
Facility Name
Research Site
City
Novy Jicin
Country
Czech Republic
Facility Name
Research Site
City
Pardubice
Country
Czech Republic
Facility Name
Research Site
City
Praha 10
Country
Czech Republic
Facility Name
Research Site
City
Praha 5
Country
Czech Republic
Facility Name
Research Site
City
Rokycany
Country
Czech Republic
Facility Name
Research Site
City
Trebic
Country
Czech Republic
Facility Name
Research Site
City
Balassagyarmat
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Deszk
Country
Hungary
Facility Name
Research Site
City
Gyor
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
Country
Hungary
Facility Name
Research Site
City
Pecs
Country
Hungary
Facility Name
Research Site
City
Szazhalombatta
Country
Hungary
Facility Name
Research Site
City
Szombathely
Country
Hungary
Facility Name
Research Site
City
Torokbalint
Country
Hungary
Facility Name
Research Site
City
Vasarosnameny
Country
Hungary
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Gdynia
Country
Poland
Facility Name
Research Site
City
Gorzow Wlkp
Country
Poland
Facility Name
Research Site
City
Grodzisk Mazowiecki
Country
Poland
Facility Name
Research Site
City
Jelenia Gora
Country
Poland
Facility Name
Research Site
City
Katowice
Country
Poland
Facility Name
Research Site
City
Kielce
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Lodz
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Pila
Country
Poland
Facility Name
Research Site
City
Skierniewice
Country
Poland
Facility Name
Research Site
City
Szczecin
Country
Poland
Facility Name
Research Site
City
Tarnow
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Deva
State/Province
Hunedoara
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Bucuresti
Country
Romania
Facility Name
Research Site
City
Constanta
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Bardejov
Country
Slovakia
Facility Name
Research Site
City
Bojnice
Country
Slovakia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Dunajska Streda
Country
Slovakia
Facility Name
Research Site
City
Humenne
Country
Slovakia
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Liptovsky Hradok
Country
Slovakia
Facility Name
Research Site
City
Nove Mesto Nad Vahom
Country
Slovakia
Facility Name
Research Site
City
Nove Zamky
Country
Slovakia
Facility Name
Research Site
City
Poprad
Country
Slovakia
Facility Name
Research Site
City
Povazska Bystrica
Country
Slovakia
Facility Name
Research Site
City
Presov
Country
Slovakia
Facility Name
Research Site
City
Revuca
Country
Slovakia
Facility Name
Research Site
City
Spisska Nova Ves
Country
Slovakia
Facility Name
Research Site
City
Trnava
Country
Slovakia
Facility Name
Research Site
City
Trstena
Country
Slovakia
Facility Name
Research Site
City
Zilina
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
25287629
Citation
Leidy NK, Murray LT, Monz BU, Nelsen L, Goldman M, Jones PW, Dansie EJ, Sethi S. Measuring respiratory symptoms of COPD: performance of the EXACT- Respiratory Symptoms Tool (E-RS) in three clinical trials. Respir Res. 2014 Oct 7;15(1):124. doi: 10.1186/s12931-014-0124-z.
Results Reference
derived
PubMed Identifier
24432712
Citation
Leidy NK, Murray LT, Jones P, Sethi S. Performance of the EXAcerbations of chronic pulmonary disease tool patient-reported outcome measure in three clinical trials of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Mar;11(3):316-25. doi: 10.1513/AnnalsATS.201309-305OC.
Results Reference
derived
PubMed Identifier
22197578
Citation
Kuna P, Jenkins M, O'Brien CD, Fahy WA. AZD9668, a neutrophil elastase inhibitor, plus ongoing budesonide/formoterol in patients with COPD. Respir Med. 2012 Apr;106(4):531-9. doi: 10.1016/j.rmed.2011.10.020. Epub 2011 Dec 23.
Results Reference
derived

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Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol

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