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The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT00939211

Last Updated: 2011-08-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-11-30

Brief Summary

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Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition with deteriorating lung function over the years. Patients with COPD experience symptoms of shortness of breath, cough and sputum production. This study is to assess the treatment effects after inhalation of three different single doses of AZD9164 (100, 400 and 1200 mcg) and one single dose of tiotropium (18 mcg). One dose of placebo will be given as comparator. 25 patients are to participate in the study and all will be recruited in Sweden. Each patient will visit the study doctor 9 times during the study, whereof 5 visits will be overnight visits. All examinations, treatment and the follow-up is free of charge.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AZD9164 100 mcg First, then Placebo for Spririva

1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation

Group Type EXPERIMENTAL

AZD9164

Intervention Type DRUG

Solution for inhalation through nebulization, single dose

Placebo

Intervention Type DRUG

Placebo

AZD9164 400 mcg First, then Placebo for Spiriva

1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation

Group Type EXPERIMENTAL

AZD9164

Intervention Type DRUG

Solution for inhalation through nebulization, single dose

Placebo

Intervention Type DRUG

Placebo

AZD9164 1200 mcg First, then Placebo for Spiriva

1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation

Group Type EXPERIMENTAL

AZD9164

Intervention Type DRUG

Solution for inhalation through nebulization, single dose

Placebo

Intervention Type DRUG

Placebo

Spiriva 18 mcg First, then Placebo for AZD9164

1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)

Group Type ACTIVE_COMPARATOR

Tiotropium

Intervention Type DRUG

Dry powder for inhalation, single dose

Placebo

Intervention Type DRUG

Placebo

Placebo for Spiriva First, then Placebo for AZD9164

1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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AZD9164

Solution for inhalation through nebulization, single dose

Intervention Type DRUG

Tiotropium

Dry powder for inhalation, single dose

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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Spiriva

Eligibility Criteria

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Inclusion Criteria

* A clinical diagnosis of COPD
* FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post- bronchodilator FEV1/FVC \< 70%

Exclusion Criteria

* Any clinically relevant abnormal findings at screening examinations
* Any clinically significant disease or disorder
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Leif Bjermer, Prof, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital in Lund, Sweden

Locations

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Research Site

Gothenburg, , Sweden

Site Status

Research Site

Luleå, , Sweden

Site Status

Research Site

Lund, , Sweden

Site Status

Countries

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Sweden

References

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Bjermer L, Bengtsson T, Jorup C, Lotvall J. Local and systemic effects of inhaled AZD9164 compared with tiotropium in patients with COPD. Respir Med. 2013 Jan;107(1):84-90. doi: 10.1016/j.rmed.2012.09.014. Epub 2012 Oct 23.

Reference Type DERIVED
PMID: 23098686 (View on PubMed)

Other Identifiers

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D1882C00003

Identifier Type: -

Identifier Source: org_study_id

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