The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01205269 | Completed Phase 2 Results

• 2 other identifiers: D1883C00004EudraCT number: 2010-020506-15
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease (COPD); safety; inhalation; long-acting muscarinic receptor antagonist (LAMA)

Outcome Measures

Primary Outcomes (2)

• Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose

  Maximum FEV1 value

  0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h

• Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose

  Trough FEV1 value

  22 h, 24 h, 26 h

Secondary Outcomes (9)

• Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose

  0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h

• Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose

  0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h

• Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose

  0, 30 min, 2 h, 4 h

• Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose

  0, 30 min, 2 h, 4 h

• Pulse, Average Effect Over 0 - 4 Hours Post-dose

  0, 30 min, 2 h, 4 h

Study Arms (6)

First 50 mcg, then 200 mcg, then placebo

EXPERIMENTAL

period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo

Drug: AZD8683, 50 mcg; Drug: Placebo; Drug: AZD8683, 200 mcg

First 50 mcg, then placebo, then 200 mcg

EXPERIMENTAL

period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg

Drug: AZD8683, 50 mcg; Drug: Placebo; Drug: AZD8683, 200 mcg

First 200 mcg, then placebo, then 50 mcg

EXPERIMENTAL

period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg

Drug: AZD8683, 50 mcg; Drug: Placebo; Drug: AZD8683, 200 mcg

First 200 mcg, then 50 mcg, then placebo

EXPERIMENTAL

period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo

Drug: AZD8683, 50 mcg; Drug: Placebo; Drug: AZD8683, 200 mcg

First placebo, then 200 mcg, then 50 mcg

EXPERIMENTAL

period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg

Drug: AZD8683, 50 mcg; Drug: Placebo; Drug: AZD8683, 200 mcg

First placebo, then 50 mcg, then 200 mcg

EXPERIMENTAL

period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg

Drug: AZD8683, 50 mcg; Drug: Placebo; Drug: AZD8683, 200 mcg

Interventions

AZD8683, 50 mcg DRUG

Dry powder for inhalation, single dose

First 200 mcg, then 50 mcg, then placebo; First 200 mcg, then placebo, then 50 mcg; First 50 mcg, then 200 mcg, then placebo; First 50 mcg, then placebo, then 200 mcg; First placebo, then 200 mcg, then 50 mcg; First placebo, then 50 mcg, then 200 mcg

Placebo DRUG

Dry powder for inhalation, single dose

First 200 mcg, then 50 mcg, then placebo; First 200 mcg, then placebo, then 50 mcg; First 50 mcg, then 200 mcg, then placebo; First 50 mcg, then placebo, then 200 mcg; First placebo, then 200 mcg, then 50 mcg; First placebo, then 50 mcg, then 200 mcg

AZD8683, 200 mcg DRUG

Dry powder for inhalation, single dose

First 200 mcg, then 50 mcg, then placebo; First 200 mcg, then placebo, then 50 mcg; First 50 mcg, then 200 mcg, then placebo; First 50 mcg, then placebo, then 200 mcg; First placebo, then 200 mcg, then 50 mcg; First placebo, then 50 mcg, then 200 mcg

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of COPD
• Current or ex-smokers
• FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC \< 70%

You may not qualify if:

• Any clinically significant disease or disorder
• Any clinically relevant abnormal findings at screening examinations
• Family history or presence of glaucoma
• Need of long term oxygen therapy

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Bialystok, Poland

Location

Research Site

Bydgoszcz, Poland

Location

Research Site

Lodz, Poland

Location

Research Site

Proszowice, Poland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Piotr Kuna, MD Professor

  Poland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 20, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 19, 2014
• Results First Posted: November 13, 2013

Record last verified: 2014-02

Locations

PL (4)