Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03480347
Other study ID # IRAS Project ID: 206796
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 17, 2018
Est. completion date April 30, 2023

Study information

Verified date August 2021
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Most existing medical research has focused on patients with well-established COPD and poor lung function. Whilst this is important because such patients have lots of symptoms and problems, in some respects a better way of reducing health problems in the future would be to develop a strategy which focuses on patients with milder disease, and identifies which ones will go on to develop more severe problems and why these problems occur. The research in this application is designed to investigate these issues. The main objective of the Partnership is to study the very early stages of the development of COPD. The investigators will do this by recruiting a novel cohort of smokers (age 30-45), in whom the investigators will follow the trajectories of lung function decline to identify prospectively those at risk of excess decline. This programme forms a unique UK consortium of 8 academic centres with excellent high quality publication records and broad experience in mechanistic, translational, clinical and epidemiological studies in COPD with key capabilities including primary care.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1000
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers
Gender All
Age group 30 Years to 45 Years
Eligibility Inclusion Criteria: Subjects eligible for enrolment in the study must meet all the following criteria: - Informed Consent: Subjects must give their signed and dated written informed consent to participate - Gender: Male or female subjects - Age: 30-45 years of age at screening - Smokers of at least 10 pack years - Have either normal lung function or mild lung function abnormalities - Subject groups will have one of the following: - A. Subjects (smokers) with mild airflow limitation defined as an FEV1/FVC ratio <lower limit of normal and FEV1 > 80% of predicted normal and no symptoms. This group will make up at least 30% of the total cohort. - B. Subjects (smokers) with mild airflow limitation as defined above and presence of respiratory symptoms defined as presence of chronic cough and/or chronic sputum and/or breathlessness equivalent to mMRC Grade 1 or higher. This group will make up no more than 25% of the total cohort. - C. Subjects (smokers) with normal lung function defined as FEV1/FVC > lower limit of normal and FEV1 > 80% of predicted normal, with or without symptoms. This group will make up at least 30% of the total cohort. Exclusion Criteria: - Individuals currently diagnosed and treated for asthma will be excluded from the study, but individuals with a past history of childhood wheezing and of asthma may be included provided that they did not previously receive regular maintenance inhaled therapy with inhaled corticosteroids' - Subjects with another known chronic respiratory disease - other than mild airflow limitation as defined above, predominantly cannabis or shisha smokers - Subjects with autoimmune disease, diabetes, hypertension, thyroid disease or bronchiectasis, significant cardio-renal disease (including significant hypertension, atrial fibrillation, Hypertrophic Cardiomyopathy, significant cardiovascular disease), Malignancies. - Clinically relevant abnormal laboratory values available at the screening assessment that could interfere with the objectives of the study or safety of the volunteer. - Subjects who are actively enrolled in an interventional clinical trial - Subjects with BMI >35 - Female participants who are pregnant or breastfeeding.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Royal Brompton and Harefield NHS Foundation Trust London

Sponsors (9)

Lead Sponsor Collaborator
Imperial College London Nanyang Technological University, Queen's University, Belfast, University College, London, University of Birmingham, University of Edinburgh, University of Manchester, University of Nottingham, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Annual change in lung function assessed by post-bronchodilator at 6 monthly intervals over a 3 year period. Three years
Primary Annual change in lung function assessed by body box plethysmography at 6 monthly intervals over a 3 year period. Three years
Secondary Lung tissue attenuation and airway dimensions determined by CT-Scanning Three years
Secondary Lung tissue attenuation and airway dimensions Assessed by full blood and differential counts Three years
Secondary Lung tissue attenuation and airway dimensions Assessed by prevalence of chronic bronchitis as determined by MRC Bronchitis Questionnaire Three years
Secondary Lung tissue attenuation and airway dimensions Assessed by respiratory symptoms, as determined by CAT Questionnaire Three years
Secondary Lung tissue attenuation and airway dimensions Assessed by dyspnoea as determined by MRC Dyspnoa Scale Three years
Secondary Lung tissue attenuation and airway dimensions Assessed by respiratory infections as determined by Respiratory Infection Questionnaire Three years
Secondary Lung tissue attenuation and airway dimensions Assessed by depression and anxiety as determined by Hospital Anxiety Depression Scale Three years
See also
  Status Clinical Trial Phase
Completed NCT05102305 - A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
Completed NCT01867762 - An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Phase 2
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03089515 - Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust N/A
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT05552833 - Pulmonary Adaptive Responses to HIIT in COPD N/A
Recruiting NCT05835492 - A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
Recruiting NCT05631132 - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases? N/A
Completed NCT03244137 - Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Not yet recruiting NCT03282526 - Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease N/A
Completed NCT02546700 - A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Withdrawn NCT04446637 - Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD Phase 3
Completed NCT04535986 - A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT03256695 - Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Withdrawn NCT04042168 - Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT03414541 - Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT02552160 - DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy