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AsthmaPhase 2NCT00945932

A Study to Evaluate the Effect of Repeat Doses of GW870086X in Mild to Moderate Asthmatics

A Phase 2 study testing GW870086X in people with Asthma, run by GlaxoSmithKline at 8 sites in Germany.

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 measure the effect of repeat inhaled doses of GW870086X on lung function. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Asthma
What is being tested?
GW870086X
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
8 sitesGermany
Study dates
Jul 2009to Dec 2009
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
  • 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 amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and oestradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
  • Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 90-95 hours post-last dose.
  • Body weight, men >/= 50 kg, women >/= 45 kg and BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
  • 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-2 agonist therapy by inhalation.
  • Severity of Disease: A best FEV1 of 40%-85% of the predicted normal value during the Visit 1 screening period.
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  • No history of smoking within 6 months of the start of the study, and with a total pack year history of </= 10 pack years
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Single QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
  • AST and ALT < 2xULN; alkaline phosphatase and bilirubin </= 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

Who cannot join

  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • A positive pre-study drug/alcohol screen.
  • Subject is mentally or legally incapacitated.
  • Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis).
  • Clinically significant abnormalities in safety laboratory analysis at screening.
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  • Subject has known history of hypertension or is hypertensive at screening. Hypertension at screening is defined as persistent systolic BP >140mmHg or diastolic BP > 90mmHg.
  • Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
  • History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures.
  • Administration of oral, injectable or dermal steroids within 8 weeks of screening.
  • Administration of intranasal and/or inhaled steroids within 2 week of the screening visit. Prior to this the subject's maximum daily dose must be less than FP equivalent 250mcg.
  • Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within the 4 weeks before screening and led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subjects asthma status or the subjects ability to participate in the study.
  • Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 8 weeks of screening. A subject must not have had any hospitalisation for asthma within 6 months prior to screening
  • The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
  • A positive test for HIV antibody.
  • History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
  • 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 new chemical entities within 12 months prior to the first dosing day.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. Paracetamol is an exception and will be permitted at daily doses of up to 4 g from screening to follow-up.
  • Has taken Xanthines (including theophylline, but not including caffeine), anticholinergics, cromoglycates and/or long-acting beta-2 agonists within 1 week prior to screening and is unable to abstain from them throughout the study.
  • Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-histamines and anti-asthma (not including steroids), anti-rhinitis or hay fever medication, other than short acting inhaled beta-2 agonists and paracetamol (up to 4 g per day) for the treatment of minor ailments eg headache from 7 days before screening until the follow-up visit.
  • Unable to abstain from medication or supplements that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole from screening and throughout the study.
  • Unable to use the DISKHALER device correctly.
  • History of sensitivity to any of the study medications (including lactose), or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 ml within a 56 day period.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subjects who are kept due to regulatory or juridical order in an institution.
  • Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
  • Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Germany8 sites

  • GSK Investigational Site

    Berlin, State of Berlin, 10367

  • GSK Investigational Site

    Berlin, State of Berlin, 10717

  • GSK Investigational Site

    Berlin, State of Berlin, 10787

  • GSK Investigational Site

    Berlin, State of Berlin, 14057

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Geesthacht, Schleswig-Holstein, 21502

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Rüdersdorf, Brandenburg, 15562

Other trials in Germany

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, 2-way Crossover Study to Determine the Efficacy of Repeat Inhaled Doses of GW870086X on FEV1 in Mild to Moderate Asthmatics

This study will measure the effect of repeat inhaled doses of GW870086X on lung function.

Conditions
Asthma
Being tested
GW870086X, Placebo
Keywords
asthma, GW870086X, Efficacy, FEV1, repeat-dose
Medical subject headings
Asthma

What participants receive

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

  • GW870086XDrug

    Investigational product

  • PlaceboDrug

    Placebo control

Study groups in NCT00945932
Study groupRoleWhat they receive
28 day repeat doseExperimentalNot described
Receives: Drug: GW870086X; Drug: Placebo

What is being measured

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

  1. Lung function as measured by FEV1

    Measured: Day 28

Secondary outcomes (4)

  1. Lung function as measured by FEV1

    Measured: Day 7 and 14

  2. Lung function as measured by PEFR

    Measured: Twice daily over 28 days

  3. Rescue medication usage

    Measured: 4-5 months

  4. Assess safety and tolerability

    Measured: 4-5 months

Timeline

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

  1. First posted24 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2009
  4. Study completionDec 2009

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00945932
Sponsor's protocol ID
112851
Status last verified
Oct 2016
First submitted
16 Jul 2009
Last updated
12 Oct 2016
Results posted
No
Data monitoring committee
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

  • Bareille P, Hardes K, Donald AC. Efficacy and safety of once-daily GW870086 a novel selective glucocorticoid in mild-moderate asthmatics: a randomised, two-way crossover, controlled clinical trial. J Asthma. 2013 Dec;50(10):1077-82. doi: 10.3109/02770903.2013.837480. Epub 2013 Oct 1.

    PubMed 23991670

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GW870086X in people with Asthma, run by GlaxoSmithKline at 8 sites in Germany.

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 10 inclusion and 29 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 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Lung function as measured by FEV1 (time frame: Day 28). 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 NCT00945932, 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 12 Oct 2016.

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Clinical Trial NCT00945932 | AzTrials