NCT00830505

Brief Summary

The purpose of this study is to compare the effects of Fluticasone/ salmeterol combination and double the dose of fluticasone on airway hyper-responsiveness to methacholine in a randomised, double blind, double dummy, cross-over trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 8, 2019

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

January 27, 2009

Last Update Submit

May 3, 2019

Conditions

Asthma

Keywords

fluticasonesalmeterolbronchoprotection

Outcome Measures

Primary Outcomes (1)

  • methacholine challenge

    methacholine challenge

    before and after a 2 week treatment period

Study Arms (2)

1: fluticasone/salmeterol

EXPERIMENTAL

2 puffs twice a day for 2 weeks

Drug: fluticasone/salmeterol

2: fluticasone

ACTIVE COMPARATOR

2 puffs twice a day for 2 weeks

Drug: fluticasone

Interventions

fluticasone/salmeterolDRUG

2 puffs twice a day for 2 weeks

Also known as: fluticasone/salmeterol combination
1: fluticasone/salmeterol
fluticasoneDRUG

2 puffs twice a day for 2 weeks

Also known as: Flixotide
2: fluticasone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent given by patient.
  • Male or female patients between 18 and 65 years of age inclusive.
  • Persistent stable asthmatics (FEV1 \> 60%)
  • On ≤ 1000 µg FP or equivalent or if on combination therapy up to 500 µg of FP or equivalent (e.g. FP/SM 125 2-puffs BD or BUD/FM 200/6 2-puffs BD)
  • Patients suffering from stable, persistent, mild to moderate asthma as defined by GINA Guidelines and for whom FEV1 \> 60 %
  • In the opinion of the investigator, able and willing to comply with the requirements of the protocol.

You may not qualify if:

  • Severe asthmatics as defined by an FEV1 \< 60% or PEF variability \>30% or with continual daytime or nocturnal symptoms.
  • Known or suspected hypersensitivity to FP or any other constituents of the Test or Reference pMDI
  • Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the study (such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA / CVA).
  • Females who are pregnant, lactating or planning to become pregnant.
  • Approximately half of the subjects will be smokers and half currently non-smokers (or who have ceased smoking at least 1 year previously).
  • Clinically significant laboratory values, as judged by the investigator.
  • Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the screening visit.
  • Patients who are scheduled to receive any other investigational drug during the course of the study.
  • Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.
  • Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.
  • Respiratory tract infection in the previous 2 months.
  • Patients with significant concomitant respiratory disease such as COPD, CF, ABPA, active pulmonary TB or bronchiectesis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asthma and Allergy Research Group

Dundee, Angus, DD1 9SY, United Kingdom

Location

Related Publications (1)

  • Clearie KL, McKinlay L, Williamson PA, Lipworth BJ. Fluticasone/Salmeterol combination confers benefits in people with asthma who smoke. Chest. 2012 Feb;141(2):330-338. doi: 10.1378/chest.11-0392. Epub 2011 Jun 2.

    PMID: 21636667RESULT

Related Links

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug CombinationFluticasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol XinafoateAlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesAndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Karine L Clearie, MBBS, MRCP

    Asthma and Allergy Research Group

    PRINCIPAL INVESTIGATOR

  • Brian J Lipworth, MBchB

    Asthma and Allergy Research Group

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 28, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 8, 2019

Record last verified: 2019-05

Locations

GB(1)