Clinical trial NCT01023516: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic
obstructive
pulmonary
lung
respiratory disease
efficacy
placebo-controlled
COPD
FEV1
St Georges Respiratory Questionnaire
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 615
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Baseline Pre-bronchodilator FEV1 (L)
timeFrame: Day 1
measure: End-value Pre-bronchodilator FEV1 (L)
timeFrame: up to week 12
Secondary outcomes:
measure: Post-bronchodilator FEV1 (L) - Baseline
timeFrame: Day 1
measure: Post-bronchodilator FEV1 (L) - End-value
timeFrame: up to week 12
measure: Pre-bronchodilator FVC (L) - Baseline
timeFrame: Day 1
measure: Pre-bronchodilator FVC (L) - End-value
timeFrame: up to week 12
measure: Post-bronchodilator FVC (L) - Baseline
timeFrame: Day 1
measure: Post-bronchodilator FVC (L) - End-value
timeFrame: up to week 12
measure: Baseline Pre-bronchodilator FEV6 (L)
timeFrame: Day 1
measure: End-value Pre-bronchodilator FEV6 (L)
timeFrame: up to week 12
measure: Baseline Post-bronchodilator FEV6 (L)
timeFrame: Day 1
measure: End-value Post-bronchodilator FEV6 (L)
timeFrame: up to week 12
measure: Baseline Pre-bronchodilator FEF25-75% (L/Sec)
timeFrame: Day 1
measure: End-value Pre-bronchodilator FEF25-75% (L/Sec)
timeFrame: up to week 12
measure: Baseline Post-bronchodilator FEF25-75% (L/Sec)
timeFrame: Day 1
measure: End-value Post-bronchodilator FEF25-75% (L/Sec)
timeFrame: up to week 12
measure: Pre-bronchodilator IC (L) - Baseline
timeFrame: Day 1
measure: Pre-bronchodilator IC (L) - End-value
timeFrame: up to week 12
measure: Post-bronchodilator IC (L) - Baseline
timeFrame: Day 1
measure: Post-bronchodilator IC (L) - End-value
timeFrame: up to week 12
measure: PEF - Baseline Measured by Patient at Home (L/Min) in the Morning
timeFrame: Baseline
measure: PEF - End-value Measured by Patient at Home (L/Min) in the Morning
timeFrame: Last 6 weeks on treatment
measure: FEV1 - Baseline Measured by Patient at Home (L) in the Morning
timeFrame: Baseline
measure: FEV1 - End-value Measured by Patient at Home (L) in the Morning
timeFrame: Last 6 weeks on treatment
measure: EXACT - Baseline Total Score
timeFrame: Baseline
measure: EXACT - End-value Total Score
timeFrame: Last 6 weeks on treatment
measure: BCSS - Baseline Total Score
timeFrame: Baseline
measure: BCSS - End-value Total Score
timeFrame: Last 6 weeks on treatment
measure: Sputum Colour - Baseline
timeFrame: Baseline
measure: Sputum Colour - End Value
timeFrame: End of treatment week 12
measure: Use of Reliever Medication
timeFrame: Last 6 weeks on treatment
measure: Incremental Shuttle Walk Test - Baseline
timeFrame: Day 1
measure: Incremental Shuttle Walk Test - End Value
timeFrame: Week 12 - visit 6
measure: Endurance Shuttle Walk Test - Baseline
timeFrame: Day 1
measure: Endurance Shuttle Walk Test - End Value
timeFrame: Week 12 - visit 6
measure: St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline
timeFrame: Day 1
measure: St George's Respiratory Questionnaire (COPD) - End-value Overall Score
timeFrame: Measured Day 1 and 12 weeks
measure: Exacerbations - Clinic Defined
timeFrame: Duration of the the treatment period - 12 weeks
Other outcomes:
Locations:
city: Lovech
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Russe
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Troyan
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Jihlava
country: Czech Republic
facility: Research Site
city: Jindrichuv Hradec
country: Czech Republic
facility: Research Site
city: Kladno
country: Czech Republic
facility: Research Site
city: Krnov
country: Czech Republic
facility: Research Site
city: Novy Jicin
country: Czech Republic
facility: Research Site
city: Pardubice
country: Czech Republic
facility: Research Site
city: Praha 10
country: Czech Republic
facility: Research Site
city: Praha 5
country: Czech Republic
facility: Research Site
city: Rokycany
country: Czech Republic
facility: Research Site
city: Trebic
country: Czech Republic
facility: Research Site
city: Balassagyarmat
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Deszk
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Szazhalombatta
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: Torokbalint
country: Hungary
facility: Research Site
city: Vasarosnameny
country: Hungary
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Gorzow Wlkp
country: Poland
facility: Research Site
city: Grodzisk Mazowiecki
country: Poland
facility: Research Site
city: Jelenia Gora
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Kielce
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Pila
country: Poland
facility: Research Site
city: Skierniewice
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Tarnow
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Deva
country: Romania
facility: Research Site
state: Hunedoara
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Constanta
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Bardejov
country: Slovakia
facility: Research Site
city: Bojnice
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Dunajska Streda
country: Slovakia
facility: Research Site
city: Humenne
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Liptovsky Hradok
country: Slovakia
facility: Research Site
city: Nove Mesto Nad Vahom
country: Slovakia
facility: Research Site
city: Nove Zamky
country: Slovakia
facility: Research Site
city: Poprad
country: Slovakia
facility: Research Site
city: Povazska Bystrica
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Revuca
country: Slovakia
facility: Research Site
city: Spisska Nova Ves
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Trstena
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
Study officials:
affiliation: Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny
name: Piotr Kuna, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.