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Pulmonary Disease, Chronic ObstructivePhase 1NCT00702910

A Study to Investigate the Effect of Inhaling Single Doses of Different Formulations of GW642444M in Asthmatic Patients

A Phase 1 study testing GW642444 and Magnesium Stearate in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will involve the use of a new medicine called GW642444 being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the study is to see how safe and how well tolerated the study drug is when inhaled in two different formulations as a fine powder by asthmatic… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
GW642444 and Magnesium Stearate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
3 sitesin 2 countries
Study dates
27 Apr 2008to 4 Oct 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with a documented history of persistent asthma, with the exclusion of other significant pulmonary diseases (e.g. chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia).
  • Male subjects or female subjects aged between 18 to 70 years.
  • A female subject is eligible to participate if she is of:
  • Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (< 140 pmol/L) is confirmatory.
  • Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 2 days post last-dose.
  • Subjects who are current non-smokers, who have not used any inhaled tobacco products (snuff is permitted) in the 12 month period preceding the screening visit and who have a pack history of ≤ 10 pack years.
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  • Subjects with clinically stable, mild to moderate persistent asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator FEV1 ≥ 60 % predicted as defined in the GINA guidelines [Global Initiative for Asthma (GINA), 2006] (having abstained from bronchodilators for the required period). Predicted values are based on the ECCS 1993 normal ranges.
  • Body weight ≥ 50 kg and body mass index (BMI) within the range 19 - 29.9 kg/m2
  • During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of ≥ 12.0% over baseline and an absolute change of ≥ 200 mL within 30 minutes following a single 400 mcg salbutamol dose.
  • ECG criteria as per protocol
  • Subjects who are currently taking ICS at a total daily dose of 200 to 500 mcg of FP or equivalent ICS.
  • Subjects who are able and willing to give written informed consent to take part in the study.

Who cannot join

  • Subjects who have a past or present disease, which as judged by the Investigator and the Medical Monitor, which may affect the safety of the subject or outcome of this study.
  • A screening Holter ECG tracing that reveals clinically concerning arrhythmias.
  • Subjects who have suffered an upper or lower respiratory tract infection within 4 weeks of the screening visit
  • Subjects with a history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with either respiratory arrest or hypoxic seizures.
  • Asthma exacerbations requiring treatment with oral corticosteroids: any exacerbations within 3 months of the screening visit or two or more exacerbations within 6 months of the screening visit or admittance to hospital for an asthma exacerbation within 1 year of the screening visit.
  • Subjects classified as suffering from severe asthma as defined by the ATS guidelines
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  • Subjects who have taken high doses of an inhaled corticosteroid (> 500 mcg FP/day or equivalent) within 8 weeks of the screening visit or oral steroids within 12 weeks of the screening visit.
  • Subjects who have changed their inhaled corticosteroid treatment within the last 6 weeks before screening or can be expected to do so during the study.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than four NCE's within 12 months prior to the first dosing day
  • Any adverse reaction including immediate or delayed hypersensitivity to any β2 agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of GW642444 inhalation powder (e.g., lactose, milk protein, magnesium stearate).
  • Subjects with a positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody or HIV result (if tested as per site SOPs) within 3 months of the start of the study.
  • Neurological or psychiatric disease or history of drug or alcohol abuse which would interfere with the subject's proper completion of the protocol requirements, including compliance.
  • Abuse of alcohol is defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females).
  • 1 unit is equivalent to a half pint (220 mL) of beer or 1 measure (25 mL) of spirits or 1 glass (125 mL) of wine.
  • The subject has a positive pre-study urine drug test screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
  • The subject has a positive pre-study alcohol or smoking breath or urinary test.
  • Where participation in the study would result in donation of blood in excess of 500 mL within a 56 day period.
  • Subjects with clinically relevant findings on laboratory safety tests.
  • Subjects with laboratory values outside the reference range may be included if the Investigator and medical monitor agree that these findings would not put the subject at risk or interfere with the objectives of the study.
  • Subjects with known hypersensitivity to salbutamol or any ingredient in this preparation
  • Subjects who have taken P-gp inhibitors and CYP 450 3A4 inhibitors (e.g. Ketoconazole) within 6 weeks or theophyllines within 2 weeks of the screening visit.
  • Inability to use the novel dry powder inhaler.
  • Pregnant females as determined by positive hCG (serum or urine) test at screening or prior to dosing.
  • Lactating females.
  • Unwillingness or inability to follow the procedures outlined in the protocol.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Australia2 sites

  • GSK Investigational Site

    Auchenflower, Queensland, 4066

  • GSK Investigational Site

    Clayton, Victoria, 3168

Other trials in Australia

New Zealand1 site

  • GSK Investigational Site

    Wellington, 6035

Other trials in New Zealand

About this study

Official title: A Randomised, Single-dose, Double-blind, Placebo-controlled, 5-way Crossover Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Doses of GW642444M With and Without Magnesium Stearate in Asthmatic Patients

This study will involve the use of a new medicine called GW642444 being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the study is to see how safe and how well tolerated the study drug is when inhaled in two different formulations as a fine powder by asthmatic patients. In addition, the study is designed to examine the effect of the study drug on the lungs, how the study drug affects parts of the body other than the lungs and to see how the body affects the study drug when it is given in single doses.

Being tested
Placebo, GW642444, Magnesium Stearate
Keywords
Asthma patients, Magnesium stearate, Tolerability, Safety, Lactose, GW642444M, Pharmacodynamics, Efficacy, Pharmacokinetics
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    comparator

  • GW642444Drug

    Also called Placebo

    investigational drug or placebo

  • Magnesium StearateDrug

    Magnesium Stearate

Study groups in NCT00702910
Study groupRoleWhat they receive
GW642444M/lactoseExperimentalGW642444M/lactose 6.25, 25 and 100 microgram, single inhaled dose for two days treatment in each treatment sequence (crossover design)
Receives: Drug: Placebo; Drug: GW642444; Drug: Magnesium Stearate
GW642444M/MgStExperimentalGW642444M/MgSt 6.25, 25 and 100 microgram, single inhaled dose for two days treatment in each treatment sequence (crossover design)
Receives: Drug: Placebo; Drug: GW642444; Drug: Magnesium Stearate
PlaceboPlacebo comparatorPlacebo containing lactose, single inhaled dose for two days treatment in each treatment sequence (crossover design)
Receives: Drug: Placebo; Drug: GW642444; Drug: Magnesium Stearate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from baseline (pre-dose) FEV1 in trough (mean of the FEV1 values obtained 23 and 24 hours after dosing) FEV1

    Measured: on going

Secondary outcomes (11)

  1. Mean change from baseline (pre-dose) in FEV1 (i.e. derive separate responses for each FEV1 obtained over 24 hours after dosing).

    Measured: on going

  2. General safety and tolerability, including adverse events, laboratory safety tests (haematology, clinical chemistry and urinalysis), vital signs and, 12-lead ECG.

    Measured: on going

  3. Weighted mean and maximum value (0 - 4 h) QTc(B)

    Measured: on going

  4. Weighted mean and maximum value (0 - 4 h) QTc(F)

    Measured: on going

  5. Weighted mean and maximum value (0 - 4 h) supine heart rate

    Measured: on going

  6. Weighted mean and maximum value (0 - 4 h) supine systolic blood pressure

    Measured: on going

  7. Weighted mean and minimum value (0 - 4 h) supine diastolic blood pressure

    Measured: on going

  8. Weighted mean and maximum value glucose (0 - 4 h)

    Measured: on going

  9. Weighted mean and minimum value potassium (0 - 4 h)

    Measured: on going

  10. Single dose derived plasma pharmacokinetic parameters (AUC(0-t), Cmax, tmax) for GW642444 and GI179710 (triphenylacetate counterion)

    Measured: on going

  11. Estimate GW642444 concentration (Cmax) -systemic pharmacodynamic relationship for PD parameters, including heart rate, potassium & glucose levels

    Measured: on going

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2008 (estimated)
  2. Study start27 Apr 2008
  3. Primary completion4 Oct 2008
  4. Study completion4 Oct 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00702910
Sponsor's protocol ID
B2C111401
Status last verified
Aug 2017
First submitted
18 Jun 2008
Last updated
10 Aug 2017
Results posted
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Kempsford R, Norris V, Siederer S. Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther. 2013 Apr;26(2):256-64. doi: 10.1016/j.pupt.2012.12.001. Epub 2012 Dec 8.

    PubMed 23232038

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GW642444 and Magnesium Stearate in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline (pre-dose) FEV1 in trough (mean of the FEV1 values obtained 23 and 24 hours after dosing) FEV1 (time frame: on going). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00702910, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.

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