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

NCT01023516 | Completed Phase 2 Results DMC

• 1 other identifier: D0520C00020
• Study Type: interventional
• Target: 615
• Locations: 6 countries
• Sites: 66

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic; obstructive; pulmonary; lung; respiratory disease; efficacy; placebo-controlled; COPD; FEV1; St Georges Respiratory Questionnaire

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 1

• End-value Pre-bronchodilator FEV1 (L)

  End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)

  up to week 12

Secondary Outcomes (36)

• Post-bronchodilator FEV1 (L) - Baseline

  Day 1

• Post-bronchodilator FEV1 (L) - End-value

  up to week 12

• Pre-bronchodilator FVC (L) - Baseline

  Day 1

• Pre-bronchodilator FVC (L) - End-value

  up to week 12

• Post-bronchodilator FVC (L) - Baseline

  Day 1

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD9668

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD9668 DRUG

2 x 30 mg oral tablets bd for 12 weeks

1

Placebo DRUG

2 x matched placebo to oral tablet bd for 12 weeks

2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (66)

Research Site

Lovech, Bulgaria

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Rousse, Bulgaria

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Sofia, Bulgaria

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Stara Zagora, Bulgaria

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Troyan Municipality, Bulgaria

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Varna, Bulgaria

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Jihlava, Czechia

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Jindřichův Hradec, Czechia

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Kladno, Czechia

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Krnov, Czechia

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Nový Jičín, Czechia

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Pardubice, Czechia

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Prague, Czechia

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Rokycany, Czechia

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Třebíč, Czechia

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Balassagyarmat, Hungary

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Budapest, Hungary

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Debrecen, Hungary

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Deszk, Hungary

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Győr, Hungary

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Nyíregyháza, Hungary

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Pécs, Hungary

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Százhalombatta, Hungary

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Szombathely, Hungary

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Törökbálint, Hungary

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Vásárosnamény, Hungary

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Bialystok, Poland

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Gdynia, Poland

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Gorzow Wlkp, Poland

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Grodzisk Mazowiecki, Poland

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Jelenia Góra, Poland

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Katowice, Poland

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Kielce, Poland

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Krakow, Poland

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Lodz, Poland

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Lublin, Poland

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Piła, Poland

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Skierniewice, Poland

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Szczecin, Poland

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Tarnów, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Constanța, Constanța County, Romania

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Deva, Hunedoara County, Romania

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Bucharest, Romania, Romania

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Bucharest, Romania

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Iași, Romania

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Bardejov, Slovakia

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Bojnice, Slovakia

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Bratislava, Slovakia

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Dunajská Streda, Slovakia

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Humenné, Slovakia

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Košice, Slovakia

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Liptovský Hrádok, Slovakia

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Nové Mesto nad Váhom, Slovakia

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Nové Zámky, Slovakia

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Poprad, Slovakia

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Považská Bystrica, Slovakia

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Prešov, Slovakia

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Revúca, Slovakia

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Spišská Nová Ves, Slovakia

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Trnava, Slovakia

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Trstená, Slovakia

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Žilina, Slovakia

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Related Publications (3)

• 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.

  PMID: 25287629 DERIVED

• 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.

  PMID: 24432712 DERIVED

• 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.

  PMID: 22197578 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchiolitis Obliterans Syndrome; Respiration Disorders

Interventions

N-((5-(methanesulfonyl)pyridin-2-yl)methyl)-6-methyl-5-(1-methyl-1H-pyrazol-5-yl)-2-oxo-1-(3-(trifluoromethyl)phenyl)-1,2-dihydropyridine-3-carboxamide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Graft vs Host Disease; Immune System Diseases

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Piotr Kuna, Professor

  Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 3, 2012
• Results First Posted: August 3, 2012

Record last verified: 2012-06

Locations

CZ (9); PL (16); RO (5); HU (11); SL (17); BU (8)