Inhaler Lung Deposition in Chronic Obstructive Pulmonary Disease (COPD)

NCT01721291 | Completed Phase 4 Results

• 3 other identifiers: NIHRCDFNIHR-CDF-2011-04-0532011-005544-10
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic obstructive pulmonary disease (COPD) experience breathing difficulties because the airways deep in their lungs become narrowed. COPD patients use inhaler drugs to provide relief from breathlessness. However, current inhalers are inefficient as they deliver a 'coarse-mist' of drug-droplets that do not reach the deep airways. In our study, we will use an inhaler of 'fine-mist' drug-droplets, tagged with a radioactive tracer to track them. We will take images of the lungs to see if the fine-mist droplets reach the deep airways, and assess if this improves the breathing capacity in our patients. Our research may allow the development of new, more efficient inhalers to improve treatment for patients with COPD.

Conditions

CHRONIC OBSTRUCTIVE PULMONARY DISEASE; ASTHMA; HEALTHY SUBJECTS

Keywords

CHRONIC OBSTRUCTIVE PULMONARY DISEASE; ASTHMA; SALBUTAMOL; ALBUTEROL; VENTOLIN; LUNG PHYSIOLOGY; LUNG DEPOSITION; INHALERS; DRUG THERAPY

Outcome Measures

Primary Outcomes (1)

• ANALYSIS OF LUNG DEPOSITION - Penetration Index

  Images of the lungs will be taken for radiolabelled salbutamol treatment. The images will be processed using computer software and the lungs divided into central airways (C - region) and peripheral airways (P -region). We will analyse the amount of radiolabelled salbutamol in each region and calculate how deep into the lungs the inhaled salbutamol has reached by using the ratio C/P which is known as the Penetration Index.

  5 MINUTES AFTER INHALATION OF SALBUTAMOL

Study Arms (4)

COPD 1

EXPERIMENTAL

COPD patients

Drug: SALBUTAMOL

Healthy

EXPERIMENTAL

Healthy participants

Drug: SALBUTAMOL

COPD 2

EXPERIMENTAL

Second group of COPD patients

Drug: SALBUTAMOL

Asthmatics

ACTIVE COMPARATOR

Asthmatics patients

Drug: SALBUTAMOL

Interventions

SALBUTAMOL DRUG

In the LUNG DEPOSITION STUDY; SALBUTAMOL INHALED VIA RESEARCH NEBULISER at 3 PARTICLES SIZES OF 1.5 MICRONS, 3 MICRONS AND 6 MICRONS WILL BE GIVEN AT SLOW INHLATION AND AGAIN AT FAST INHALTION;DOSAGE- 30 MICROGRAMS, ONE SINGLE INHALATION ONLY. IN ADDITION, SALBUTAMOL AT 200 MICROGRAMS INHALED VIA A STANDARD METERED DOSE INHALER WILL ALSO BE GIVEN AS A SINGLE INHALATION. In the LUNG PHYSIOLOGY STUDY; SALBUTAMOL INHALED VIA RESEARCH NEBULISER at 3 PARTICLES SIZES OF 1.5 MICRONS, 3 MICRONS AND 6 MICRONS WILL BE GIVEN AT TWO DOSAGES OF 30 MICROGRAMS AND AGAIN AT 15 MICROGRAMS, ONE SINGLE INHALATION ONLY. IN ADDITION, SALBUTAMOL AT 200 MICROGRAMS INHALED VIA A STANDARD METERED DOSE INHALER WILL ALSO BE GIVEN AS A SINGLE INHALATION. ALL INHALATIONS WIL BE AT SLOW INHALTION IN THIS PART OF THE STUDY.

Also known as: ALBUTEROL; VENTOLIN; SALMOL

Asthmatics; COPD 1; COPD 2; Healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- COPD patients, either male or female, over the age of 40 with a clinical 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 nonsmokers(or exsmokers 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 clinical diagnosis of Asthma with airflow obstruction (FEV1/FVC\<0.7).
• All patients should be capable of giving informed consent.

You may not qualify if:

• Oral corticosteroids taken within last month.
• Current involvement (or involvement in the last 4 weeks)in clinical trials assessing investigational medicinal products.
• Previous adverse reaction to short or long acting β2 agonist.
• Any subject with a contraindication to taking inhaled beta2-adrenoceptor agonists (especially salbutamol) as listed in the British National Formulary will not be entered into this study.
• Those who have experienced an acute respiratory exacerbation requiring emergency room treatment and/ or hospitalisation within four weeks of visit 1 (screening visit).
• Pregnant or breastfeeding women.
• Subjects unable to give Informed Consent.

Sponsors & Collaborators

• Imperial College London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Royal Brompton Hospital & Imperial College London

London, SW3 6LY, United Kingdom

Location

Related Publications (1)

• Usmani OS, Biddiscombe MF, Barnes PJ. Regional lung deposition and bronchodilator response as a function of beta2-agonist particle size. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1497-504. doi: 10.1164/rccm.200410-1414OC. Epub 2005 Sep 28.

  PMID: 16192448 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Dr Omar Usmani
• Organization: Imperial College London

o.usmani@imperial.ac.uk

+440(0) 207351 8051

Study Officials

• Omar S USMANI, MD, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: November 5, 2012
• Study Start: October 1, 2012
• Primary Completion: November 27, 2017
• Study Completion: November 27, 2017
• Last Updated: March 6, 2023
• Results First Posted: March 6, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)