Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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Official title:

A 4-week Double-blind, Placebo-controlled, Randomized, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629239
• Other study ID #: D3540C00005
• Status: Completed
• Phase: Phase 2
• First received: February 25, 2008
• Last updated: November 4, 2010
• Start date: January 2008
• Est. completion date: August 2008

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyNorway: Norwegian Medicines AgencyDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyNetherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of COPD, with symptoms for more than 1 year

• Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)

• Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator

Exclusion Criteria:

• Clinical suspicion of active tuberculosis

• Any current clinically significant respiratory tract disorder other than COPD

• History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AZD4818
Dry Powder, inhalation, b.i.d., 4 weeks
• Placebo

Locations

Country	Name	City	State
Denmark	Research Site	Hvidovre
Denmark	Research Site	København Nv
Denmark	Research Site	Odense C
Finland	Research Site	Helsinki
Finland	Research Site	Preitilä
Finland	Research Site	Tampere
Netherlands	Research Site	Breda
Netherlands	Research Site	Groningen
Norway	Research Site	Elverum
Norway	Research Site	Oslo
Norway	Research Site	Trondheim
Sweden	Research Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Finland,  Netherlands,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Experiencing Adverse Events	Number of patients who had an Adverse Event	At all study visits	No
Secondary	Forced Expiratory Volume 1 (FEV1)	Change in (FEV1) from baseline to end of treatment	Before treatment and after 1, 2, 3 and 4 weeks of treatment	No
Secondary	Forced Vital Capacity (FVC)	Change in FVC from baseline to end of treatment	Before treatment and after 1, 2, 3 and 4 weeks of treatment	No
Secondary	Vital Capacity (VC)	Change in VC from baseline to end of treatment	Before treatment and after 1, 2, 3 and 4 weeks of treatment	No
Secondary	Inspiratory Capacity (IC)	Change from IC baseline to end of treatment	Before treatment and after 1, 2, 3 and 4 weeks of treatment	No
Secondary	Forced Expiratory Flow (FEF) 25%-75%	Change in FEF from baseline to end of treatment	Before treatment and after 1, 2, 3 and 4 weeks of treatment	No
Secondary	Peak Expiratory Flow (PEF) Morning	Change from average during run-in to average during treatment	Daily during run-in and treatment	No
Secondary	Peak Expiratory Flow (PEF) Evening	Change in PEF from average during run-in to average during treatment	Daily during run-in and treatment	No
Secondary	The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total	Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)	Before treatment and after 1, 2, 3 and 4 weeks of treatment	No
Secondary	Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness	Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).	Daily during run-in and treatment	No
Secondary	Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness	Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).	Daily during run-in and treatment	No
Secondary	Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score	Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).	Daily during run-in and treatment	No
Secondary	Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score	Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).	Daily during run-in and treatment	No
Secondary	6-minute Walk Test	Change from baseline to end of treatment	Before treatment and after 4 weeks of treatment	No