Clinical trial NCT00629239: Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
tolerability
inhalation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-05
Enrollment: 65
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Experiencing Adverse Events
timeFrame: At all study visits
Secondary outcomes:
measure: Forced Expiratory Volume 1 (FEV1)
timeFrame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
measure: Forced Vital Capacity (FVC)
timeFrame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
measure: Vital Capacity (VC)
timeFrame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
measure: Inspiratory Capacity (IC)
timeFrame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
measure: Forced Expiratory Flow (FEF) 25%-75%
timeFrame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
measure: Peak Expiratory Flow (PEF) Morning
timeFrame: Daily during run-in and treatment
measure: Peak Expiratory Flow (PEF) Evening
timeFrame: Daily during run-in and treatment
measure: The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total
timeFrame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
measure: Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
timeFrame: Daily during run-in and treatment
measure: Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
timeFrame: Daily during run-in and treatment
measure: Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
timeFrame: Daily during run-in and treatment
measure: Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score
timeFrame: Daily during run-in and treatment
measure: 6-minute Walk Test
timeFrame: Before treatment and after 4 weeks of treatment
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Research Site
city: København Nv
country: Denmark
facility: Research Site
city: Odense C
country: Denmark
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Preitilä
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Elverum
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
Study officials:
affiliation: University Medical Centre, Groningen, The Netherlands
name: Huib AM Kerstjens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: