Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers

NCT01194700 | Completed Phase 4

• 2 other identifiers: NAI0082007-003627-20
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of plastic spacers and breath actuated spacers on respirable drug delivery of combination steroid inhaler (Seretide/Advair) and whether electrostatic charge within plastic spacers has a clinically relevant impact on the inhaled steroid delivery.

Conditions

Asthma

Keywords

lung bioavailability; asthma; seretide; Spacer

Outcome Measures

Primary Outcomes (1)

• Overnight Urinary Cortisol creatinine ratio

  This outcome measure evaluates the amount of cortisol being suppressed after inhaled steroid administration. This helps to assess the systemic effect of steroid inhalation and therefore the propensity for adrenal suppression which is a noted adverse effect with high dose inhaled steroids

  within 24 hours after study drug inhalation

Secondary Outcomes (1)

• Serum Potassium

  60 minutes post treatment

Study Arms (4)

Evohaler

EXPERIMENTAL

Drug: Seretide 250(8puffs) via Evohaler actuator; Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer; Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer; Drug: Seretide 250/placebo via Synchro-Breathe

Volumatic spacer

EXPERIMENTAL

Drug: Seretide 250(8puffs) via Evohaler actuator; Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer; Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer; Drug: Seretide 250/placebo via Synchro-Breathe

Aerochamber Plus

EXPERIMENTAL

Drug: Seretide 250(8puffs) via Evohaler actuator; Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer; Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer; Drug: Seretide 250/placebo via Synchro-Breathe

Synchro-Breathe

EXPERIMENTAL

Drug: Seretide 250(8puffs) via Evohaler actuator; Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer; Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer; Drug: Seretide 250/placebo via Synchro-Breathe

Interventions

Seretide 250(8puffs) via Evohaler actuator DRUG

8 puffs of Seretide250/Placebo via Evohaler actuator

Also known as: Advair

Aerochamber Plus; Evohaler; Synchro-Breathe; Volumatic spacer

Seretide 250 (8 puffs)/placebo via Volumatic spacer DRUG

8 puffs of Seretide 250/placebo via volumatic spacer

Also known as: Advair

Aerochamber Plus; Evohaler; Synchro-Breathe; Volumatic spacer

Seretide 250/placebo 8 puffs via Aerochamber Plus spacer DRUG

Seretide 250/placebo 8 puffs via Aerochamber Plus

Also known as: Advair

Aerochamber Plus; Evohaler; Synchro-Breathe; Volumatic spacer

Seretide 250/placebo via Synchro-Breathe DRUG

Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device

Also known as: Advair

Aerochamber Plus; Evohaler; Synchro-Breathe; Volumatic spacer

Eligibility Criteria

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

You may qualify if:

• Healthy Volunteers
• Male or female 18-65
• Informed Consent
• Ability to comply with the requirements of the protocol

You may not qualify if:

• No respiratory disease
• Smokers
• Recent respiratory tract infection (2 months).
• Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA,that may endanger the health or safety of the participant, or jeopardise the protocol.
• Any significant abnormal laboratory result as deemed by the investigators
• Pregnancy, planned pregnancy or lactation
• Known or suspected contra-indication to any of the IMP's
• Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial

Sponsors & Collaborators

• Brian J Lipworth: lead

Study Sites (1)

Asthma & Allergy Research Group, Department of cardiovascular & lung biology, Division of medicine, Ninewells Hospital & Medical School

Dundee, Tayside, DD1 9SY, United Kingdom

Location

Related Publications (1)

• Nair A, McKinlay L, Williamson P, Short P, Burns P, Lipworth BJ. Comparative lung bioavailability of fluticasone/salmeterol via a breath-actuated spacer and conventional plastic spacers. Eur J Clin Pharmacol. 2011 Apr;67(4):355-363. doi: 10.1007/s00228-010-0989-9. Epub 2011 Jan 15.

  PMID: 21240480 RESULT

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination; Metered Dose Inhalers

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Nebulizers and Vaporizers; Equipment and Supplies

Study Officials

• Arun Nair

  University of Dundee

  PRINCIPAL INVESTIGATOR

• Brian J Lipworth

  University of Dundee

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor (Clinical) Airway allergy and COPD

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 3, 2010
• Study Start: November 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

GB (1)