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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00444509




Registration number
NCT00444509
Ethics application status
Date submitted
6/03/2007
Date registered
7/03/2007
Date last updated
4/08/2017

Titles & IDs
Public title
Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.
Scientific title
A Double-blind, Placebo-controlled, Crossover Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Dose Dry Powder GW685698X Containing Magnesium Stearate in Subjects With Mild to Moderate Asthmatic Patients
Secondary ID [1] 0 0
HZA108799
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
Treatment: Drugs - GW685698X
Treatment: Drugs - GW685698X containing magnesium stearate

Experimental: Treatment 1 - Subjects will receive GW685698X 800 microgram (mcg) single inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses.

Experimental: Treatment 2 - Subjects will receive GW685698X 800 mcg containing magnesium stearate inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses.


Treatment: Drugs: GW685698X
GW685698X will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS

Treatment: Drugs: GW685698X containing magnesium stearate
GW685698X containing magnesium stearate will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability: Vital signs: for 48 hours 12-lead ECG including QT, QTc, PR and QRS intervals for 48 hours PEFR, FEV1 for 48 hours Laboratory safety tests (clinical chemistry, haematology, urinalysis) at predose Adverse events for 46 days
Timepoint [1] 0 0
Vital signs: for 48 hours
Secondary outcome [1] 0 0
Plasma GW685698X concentrations and pharmacokinetic parameters (AUC, Cmax, t1/2, tmax) following single inhaled doses in mild/moderate asthmatic patients for 48 hours. Weighted mean serum cortisol (0-24 h) on Day 1.
Timepoint [1] 0 0
following single inhaled doses in mild/moderate asthmatic patients for 48 hours.

Eligibility
Key inclusion criteria
Inclusion criteria:

- Clinically stable persistent mild/moderate asthma within the 4 weeks preceding the
screening visit,

- screening pre-bronchodilator FEV1 >or=60 % predicted,demonstrate the presence of
reversible airway disease, defined as an increase in FEV1 of >or= 12.0% over the max
of the three screening measures and an absolute change of

>or= 200 mL within 30 minutes following a single 400 mcg salbutamol dose, male or
female (of non child bearing potential or meet the contraception criteria),

- BMI 19-31 kg/m2,

- Non-smoker,

- refrains from use of prohibited medication within the specified timeframes
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Pregnant or nursing females

- History of life threatening asthma

- Subjects who are unable to stop taking protocol defined prohibited medication

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?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
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
17/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/04/2007
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a single centre, randomised, double blind, two-way crossover study, to investigate
the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder
GW685698X (800?g) containing magnesium stearate. Magnesium stearate is an excipient added to
improve the physical stability of inhaled dry powder formulations. Male and female patients
with mild/moderate asthma will be randomised to determine which order they receive a single
inhaled administration of GW685698X (800?g) with and without magnesium stearate. There will
be a wash-out period of at least 5 days between doses.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00444509
Trial related presentations / publications
This study has not been published in the scientific literature.
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/ct2/show/NCT00444509