Drug Lung Deposition In COPD

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 18.0 Level: PT Classification code 10052996 Term: Inhalation therapy System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-005544-10-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-29
• Study Completion: 2017-11-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 65

Inclusion Criteria

COPD patients, either male or female, over the age of 40 with a clincal diagnosis of COPD with airflow obstruction (FEV1/FVC<0.7) and post-bronchodilator FEV1>50% predicted, gas trapping (on lung volume testing), and decreased carbon monoxide transfer factor.

Healthy subjects will be non-smokers (or ex-smokers stopped 5 years ago), will have no respiratory disease, normal spirometry and be age-matched to the COPD patients.

Asthmatic subjects, either male or female, over the age of 18 with a clincal diagnosis of Asthma with airflow obstruction (FEV1/FVC<0.7).

Capable of giving informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1) Oral corticosteroids taken within last month.

2)Current involvement (or involvement in the last 4 weeks)in clinical trials assessing investigational medicinal products.

3)Previous adverse reaction to short or long acting ß2 agonist.

4) Any subject with a contraindication to taking inhaled beta-2 adrenoceptor agonists (especially salbutamol) as listed in the British National Formulary will not be entered into this study.

5) Those who have experienced an acute respiratory exacerbation requiring emergency room treatment and/ or hospitalisation within four weeks of visit 1 (screening visit).

6) Pregnant or breast-feeding women.

7) Subjects unable to give Informed Consent.

Study & Design

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