Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of Formoterol
NCT01555099 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 353
Last updated 2013-06-17
Summary
The purpose of the study is to assess the efficacy and safety of two staggered dose levels of inhaled once daily AZD5423 or twice daily budesonide for 12 weeks in COPD patients on a background therapy of formoterol.
Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
Interventions
- DRUG
-
AZD5423
oral inhaled
- DRUG
-
Budesonide
oral inhaled
- DRUG
-
oral inhaled
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Piotr Kuna, Professor · Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Łodzi, ul. Kopcińskiego 22, 90-153, Łódź, Poland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-04-30
- Primary Completion
- 2013-04-30
- Completion
- 2013-04-30
Countries
- Bulgaria
- France
- Hungary
- Italy
- Poland
- Russia
- Slovakia
- Ukraine
Study Locations
More Related Trials
-
Budesonide / Formoterol in Treatment of Exacerbations of COPD
NCT00239278 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00690482 ·Status: COMPLETED ·Phase: PHASE2
-
To Assess the Safety, Tolerability, and Pharmacokinetics of AZD7624 in Healthy Volunteers and COPD Patients
NCT01817855 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Investigate Safety, Tolerability and Effect of Multiple Dosing With AZD 4721 and/or With AZD 5069
NCT01962935 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy, Pharmacokinetics (PK), Safety and Tolerability Study of Inhaled AZD8871
NCT02971293 ·Status: COMPLETED ·Phase: PHASE2
-
Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)
NCT01153321 ·Status: COMPLETED ·Phase: PHASE2
-
Two-part Safety, Tolerability, Pharmacodynamic and -Kinetic Study of Inhaled AZD8871 in Asthmatic and COPD Subjects
NCT02573155 ·Status: COMPLETED ·Phase: PHASE1
-
A Single Inhalation Dose Study to Assess Efficacy, Pharmacokinetics (PK), Safety and Tolerability of AZD8871 in Patients With Long-term Lung Diseases.
NCT03645434 ·Status: COMPLETED ·Phase: PHASE2
-
A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients
NCT01498081 ·Status: COMPLETED ·Phase: PHASE2
-
Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00629239 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis
NCT01255592 ·Status: COMPLETED ·Phase: PHASE2
-
A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01168310 ·Status: COMPLETED ·Phase: PHASE2
-
A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD
NCT00215436 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01908140 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT01437540 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®
NCT01048333 ·Status: COMPLETED ·Phase: PHASE2
-
The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01205269 ·Status: COMPLETED ·Phase: PHASE2
-
Study in Patients With COPD
NCT00215423 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00758706 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD8871 in Healthy Subjects
NCT02814656 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With a Next-Generation Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
NCT05573464 ·Status: COMPLETED ·Phase: PHASE3
-
Study in Patients With COPD
NCT00215449 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study of Formoterol/Fluticasone and Salmeterol/Fluticasone in Patients With Moderate-to-severe COPD
NCT01393145 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT02345161 ·Status: COMPLETED ·Phase: PHASE3
-
AZD2115 Single Ascending Dose Study
NCT01283984 ·Status: COMPLETED ·Phase: PHASE1