The Clinical Effect of Monodisperse Fluticasone Propionate in Asthma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01662778
First received: August 7, 2012
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

The objective here is to determine that the efficiency of inhaled drug delivery can be improved by using a fine mist cloud of drug particles (as opposed to a coarse mist cloud of drug particles). This information will be valuable in designing new inhalers in order to improve their beneficial effects and reduce their side effects, by using the least possible drug dose to achieve a good patient response.

.


Condition Intervention Phase
Asthma
Drug: Fluticasone Propionate 50 micrograms
Drug: Inhaled, Metered dose inhaler, 250 micrograms dose (total dose)
Drug: Placebo monodisperse aerosol dose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Clinical Effect in Asthma of Inhaled Fluticasone Propionate Delivered as Monodisperse Aerosols

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • AMP Challenge Test PC20 [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    The concentration of Adenosine Monophosphate (AMP), measured in mg/ml, required to see a 20% fall in the patient's forced expiratory volume in 1 second (FEV1) is measured after taking FP aerosol. AMP is a bronchoconstrictor agent (ie it narrows the airways. We would expect that more would be necessary to produce the same 20% fall in FEV1 after receiving the FP than before due to the reduction in airways inflammation. This change is the primary outcome measure.


Secondary Outcome Measures:
  • Pharmacokinetic Parameters [ Time Frame: 0 to 4 hours ] [ Designated as safety issue: No ]

    The concentration of Fluticasone Propionate in blood following inhalation of the dose will be measured. This will be found by calculating the area under the curve of concentration versus time from 0 to 4 hours.

    Cmax will be measured.


  • Spirometry [ Time Frame: 0 and 4 hours ] [ Designated as safety issue: No ]
    FEV1 and FVC will be measured before and after drug administration

  • Multi-breath Nitrogen washout Test [ Time Frame: 0 and 4 hours ] [ Designated as safety issue: No ]
    At each study visit subjects will breathe in oxygen from a machine, which at the same time will measure the composition of the gases in each exhaled breath. The main gas we are interested in is nitrogen as this makes up the bulk of the air that we breathe. This test is known as the 'multi-breath nitrogen washout'. The test takes 20 minutes and we shall do this at the beginning and at the end of each study visit.

  • Acoustic Pharyngometer [ Time Frame: 0 and 4 hours ] [ Designated as safety issue: No ]
    This test uses sound waves to measure the dimensions of the throat, similar to a ship's ultrasonic−sonar


Estimated Enrollment: 24
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monodisperse Fluticasone Propionate 1.5microns
50 micrograms of monodisperse Fluticasone Propionate delivered as 1.5 micrometers
Drug: Fluticasone Propionate 50 micrograms
Drug: Fluticasone Propionate Dose 50 micrograms (total dose), Monodisperse aerosol with two differemt particle size of drug (1.5, 6.0 microns) generated by Spinning Top Aerosol Generator (STAG)
Experimental: Monodisperse Fluticasone Propionate 6.0 microns
50 micrograms of monodisperse Fluticasone Propionate delivered as 6.0 micrometers
Drug: Fluticasone Propionate 50 micrograms
Drug: Fluticasone Propionate Dose 50 micrograms (total dose), Monodisperse aerosol with two differemt particle size of drug (1.5, 6.0 microns) generated by Spinning Top Aerosol Generator (STAG)
Placebo Comparator: Placebo STAG
No active drug, just solvent delivered from STAG
Drug: Placebo monodisperse aerosol dose
Solvent only delivered, no drug
Experimental: Metered dose inhaler of Fluticasone Propionate
Fluticasone Propionate Inhaled, Metered dose inhaler, 250 micrograms dose (total dose)
Drug: Inhaled, Metered dose inhaler, 250 micrograms dose (total dose)
Inhaled, Metered dose inhaler, 250 micrograms dose (total dose), delivered via spacer

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or females aged greater than 18 years with a documented history of reversible airways disease responding to beta2−adrenergic therapy.
  2. Asthmatic patients who are free from significant cardiac, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease.
  3. Patients who are stabilized on 500 micrograms or less of inhaled beclomethasone dipropionate or alternative inhaled corticosteroid (budesonide or ciclesonide).
  4. Patients who are able and willing to give written informed consent to take part in the study
  5. Not taking any regular medication that is contraindicated in those about to receive fluitcasone propionate (as indicated in the British National Formularly); other than the oral contraceptive pill.

Exclusion Criteria:

  1. Those requiring maintenance oral or parenteral corticosteroid therapy for their airways disease or patients who have ceased maintenance oral or parenteral corticosteroid therapy within the four weeks prior to visit 1
  2. Those requiring greater than 500 micrograms of inhaled beclomethasone dipropionate or alternative inhaled corticosteroid (budesonide or ciclesonide).
  3. Subjects that have received inhaled or intravenous fluticasone propionate in the last 2 months.
  4. Those whose reversible airways obstruction has been unstable in the last four weeks (indicated by any change in their maintenance therapy).
  5. Those participants who have had a lower respiratory tract infection in the previous four weeks
  6. Those who have donated 450ml blood or more within the previous 1 month.
  7. Those who have a history of drug allergy which, in the opinion of the Unit Physician, contraindicates his/her participation in the study.
  8. Any female volunteer or females who are pregnant or lactating or are likely to become pregnant during the trial. Women of child−bearing potential may be included in the study if, in the opinion of the investigator, they are taking adequate contraceptive precautions.
  9. Participants with a known or suspected allergy to corticosteroids or any component of the formulations and/or Suspected hypersensitivity to inhaled corticosteroid (this will be asked directly at the screening visit).
  10. Any patient with a contraindication to taking an inhaled steroid and specifically FP, listed in the British National Formulary will not be entered into this study
  11. Those who have experienced an acute asthma exacerbation requiring emergency room treatment and/or hospitalisation within one month of visit 1.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662778

Contacts
Contact: Omar Usmani, MD, PhD 02073518051 o.usmani@imperial.ac.uk

Locations
United Kingdom
Asthma Lab, Royal Brompton Hospital Recruiting
London, United Kingdom, SW36LY
Department of Nuclear Medicine, Royal Brompton Hospital Active, not recruiting
London, United Kingdom, SW36NP
Sponsors and Collaborators
Imperial College London
GlaxoSmithKline
Investigators
Principal Investigator: Omar Usmani, MBBS, MRCP, PhD Imperial College London
  More Information

Publications:
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01662778     History of Changes
Other Study ID Numbers: CRO1694
Study First Received: August 7, 2012
Last Updated: August 9, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Monodisperse aerosols
Asthmatics
Pharmacokinetics
AMP Challenge
Multiple Breath Nitrogen Washout

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on October 19, 2014