Inhaler Lung Deposition in Chronic Obstructive Pulmonary Disease (COPD)
Condition: CHRONIC OBSTRUCTIVE PULMONARY DISEASE; ASTHMA; HEALTHY SUBJECTS
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: SALBUTAMOL
Intervention description: 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.
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: CHRONIC OBSTRUCTIVE PULMONARY DISEASE; ASTHMA; SALBUTAMOL; ALBUTEROL; VENTOLIN; LUNG PHYSIOLOGY; LUNG DEPOSITION; INHALERS; DRUG THERAPY

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.
    

Eligibility criteria:

        Inclusion Criteria:

        - 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.

        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 β2 agonist.

          4. 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.

          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 breastfeeding women.

          7. Subjects unable to give Informed Consent.