Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01128595




Registration number
NCT01128595
Ethics application status
Date submitted
20/05/2010
Date registered
24/05/2010
Date last updated
18/01/2017

Titles & IDs
Public title
Randomised Study Comparing the Effects of Inhaled FF/GW642444M Combination, FF and GW642444M on an Allergen Induced Asthmatic Response
Scientific title
A Randomised, Double-blind, Placebo-controlled, Four-way Crossover, Repeat Dose Study Comparing the Effect of Inhaled Fluticasone Furoate/GW642444M Combination, GW642444M and Fluticasone Furoate on the Allergen-induced Asthmatic Response in Subjects With Mild Asthma
Secondary ID [1] 0 0
113126
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: ICS -

Active comparator: ICS/LABA -

Active comparator: LABA -

Placebo comparator: Placebo -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
Timepoint [1] 0 0
Day 21 of each treatment period (up to Study Day 197)
Primary outcome [2] 0 0
LAR: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
Timepoint [2] 0 0
Day 21 of each treatment period (up to Study Day 197)
Primary outcome [3] 0 0
Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
Timepoint [3] 0 0
Day 21 of each treatment period (up to Study Day 197)
Primary outcome [4] 0 0
EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
Timepoint [4] 0 0
Day 21 of each treatment period (up to Study Day 197)
Secondary outcome [1] 0 0
Maximum Percent Change From Saline in FEV1 Between 0-2 Hrs, Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
Timepoint [1] 0 0
Day 21 of each treatment period (up to Study Day 197)
Secondary outcome [2] 0 0
Provocative Concentration of Methacholine Estimated to Result in a 20% Reduction in FEV1 (PC20) on Day 22 of Each Treatment Period
Timepoint [2] 0 0
Day 22 of each treatment period (up to Study Day 198)

Eligibility
Key inclusion criteria
- Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).

* Females of non-child bearing potential.
* Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation
* Pre-bronchodilator FEV1 >70% of predicted at screening
* Subjects who are current non-smokers
* Methacholine challenge PC20 < 8 mg/mL at screening
* Screening allergen challenge demonstrates that the subject experiences an early asthmatic response
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities

* Subject is hypertensive at screening
* Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
* History of life-threatening asthma
* Symptomatic with hay fever at screening or predicted to have symptomatic hayfever
* Unable to abstain from short acting beta agonists
* Unable to abstain from antihistamines
* Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-asthma anti-rhinitis or hay fever medication
* The subject has participated in a study with a new molecular entity during the previous 3 months or has participated in 4 or more clinical studies in the previous 12 months
* undergoing allergen desensitisation therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington
Country [2] 0 0
Sweden
State/province [2] 0 0
Göteborg
Country [3] 0 0
Sweden
State/province [3] 0 0
Lund

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
We propose to use an inhaled allergen challenge model to explore the individual contributions of the components of a novel long-acting beta agonist/ inhaled corticosteroid combination product and its components on protection from allergic triggers in asthma
Trial website
https://clinicaltrials.gov/study/NCT01128595
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01128595