Study of Lung Function and Health Outcome Improvement in Obstructive Lung Disease

Phase 1

• Conditions: Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 20.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-000154-34-DE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-10
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2420

Inclusion Criteria

1. Give their signed written informed consent to participate
2. Are at least 40 years of age and no older than 80 years
3. Moderate to very severe COPD patients who are symptomatic
4. Must be receiving one or more inhaled bronchodilators as maintenance therapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1310
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1110

Exclusion Criteria

1. Current diagnosis of asthma,
2. COPD due to a1-Antitrypsin Deficiency
3. Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months
4. Long-term-oxygen therapy (= 15 hours a day).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified