Drug Lung Deposition In COPD

Improving Inhaler Treatment and Small Airways Assessment in Chronic Obstructive Pulmonary Disease - Drug Lung Deposition In COPD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005544-10-GB

Enrollment

Registered

2012-03-29

Start date

2012-04-10

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Salbutamol Sulphate drug Substance Product Name: salbutamol sulphate Pharmaceutical Form: Inhalation vapour, liquid Trade Name: Ventolin Ev

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: COPD patients, either male or female, over the age of 40 with a clincal diagnosis of COPD with airflow obstruction (FEV1/FVC50% 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=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Q1. What is the lung deposition behaviour of inhaled bronchodilator (salbutamol)aerosols of different particle size within the airways of patients with chronic obstructive pulmonary disease (COPD)? How does this distribution compare to that observed in healthy subjects with no lung disease? ; Secondary Objective: Q2. What is the effect of different patient inhalation flows on the lung deposition of different sized bronchodilator (salbutamol) particles? Is there a specific particle size and inhalation flow to achieve optimal lung deposition in COPD patients? Q3. Does the regional deposition and distribution of inhaled bronchodilator (salbutamol) aerosols influence the clinical (physiological pharmacodynamic) and systemic (urinary pharmacokinetic) responses in COPD patients? ; Timepoint(s) of evaluation of this end point: LUNG DEPOSITION study: The timepoint of evaluation will be 5 minutes after drug inhalation. LUNG PHYSIOLOGY study: The timepoint of evaluation will be 30 minutes after drug inhalation. ; Primary end point(s): LUNG DEPOSITION study: The primary endpoint for aerosol deposition is penetration index (PI) calculated from planar-images, which will indicate differences in regional lung deposition as a function of particle size. Lung PHYSIOLOGY study: The primary endpoints are multi-breath nitrgen washout (UNGW) indices of acinar airways (Sacin) and conducting airways (Scond), which will indicate differences in small (and large) airway physiology as a function of particle size.	—

Measure

Time frame

Main Objective: Q1. What is the lung deposition behaviour of inhaled bronchodilator (salbutamol)aerosols of different particle size within the airways of patients with chronic obstructive pulmonary disease (COPD)? How does this distribution compare to that observed in healthy subjects with no lung disease? ; Secondary Objective: Q2. What is the effect of different patient inhalation flows on the lung deposition of different sized bronchodilator (salbutamol) particles? Is there a specific particle size and inhalation flow to achieve optimal lung deposition in COPD patients? Q3. Does the regional deposition and distribution of inhaled bronchodilator (salbutamol) aerosols influence the clinical (physiological pharmacodynamic) and systemic (urinary pharmacokinetic) responses in COPD patients? ; Timepoint(s) of evaluation of this end point: LUNG DEPOSITION study: The timepoint of evaluation will be 5 minutes after drug inhalation. LUNG PHYSIOLOGY study: The timepoint of evaluation will be 30 minutes after drug inhalation. ; Primary end point(s): LUNG DEPOSITION study: The primary endpoint for aerosol deposition is penetration index (PI) calculated from planar-images, which will indicate differences in regional lung deposition as a function of particle size. Lung PHYSIOLOGY study: The primary endpoints are multi-breath nitrgen washout (UNGW) indices of acinar airways (Sacin) and conducting airways (Scond), which will indicate differences in small (and large) airway physiology as a function of particle size.

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Secondary

Measure	Time frame
Secondary end point(s): The secondary outcome measures for both LUNG DEPOSITION and LUNG PHYSIOLOGY studies are: Analysis of the lung physiology (Multi-breath Nitrogen Washout(MBNW), Impulse oscillometry (IOS), Spirometry, Body plethysmography, Oral Pharngometry) and Urine pharmacokinetics ; Timepoint(s) of evaluation of this end point: MBNW, IOS and Spiromtery: The timepoint(s) of evaluation are 30, 60, 120 minutes Body Plethysmography: The timepoint(s) of evaluation are 60, 120 minutes Oral Pharyngometry: The timepoint(s) of evaluation are 30, 120 minutes Urine Pharmacokinetics: The timepoints of evaluation are 0-30minutes, 0-24 hours, 30mins -24 hours)	—

Measure

Time frame

Secondary end point(s): The secondary outcome measures for both LUNG DEPOSITION and LUNG PHYSIOLOGY studies are: Analysis of the lung physiology (Multi-breath Nitrogen Washout(MBNW), Impulse oscillometry (IOS), Spirometry, Body plethysmography, Oral Pharngometry) and Urine pharmacokinetics ; Timepoint(s) of evaluation of this end point: MBNW, IOS and Spiromtery: The timepoint(s) of evaluation are 30, 60, 120 minutes Body Plethysmography: The timepoint(s) of evaluation are 60, 120 minutes Oral Pharyngometry: The timepoint(s) of evaluation are 30, 120 minutes Urine Pharmacokinetics: The timepoints of evaluation are 0-30minutes, 0-24 hours, 30mins -24 hours)

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026