AsthmaPhase 1NCT00331058

Comparison Of Molecular Targets In Mild To Severe Asthmatics And Healthy Subjects

A Phase 1 study testing Bronchoscopsy and Prednisolone in people with Asthma, run by GlaxoSmithKline at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary goal of this study is to compare the expression of key GSK drug targets across the 4 asthma phenotypes and healthy subjects and secondarily to evaluate changes in target expression in response to a 2-week course of corticosteroids across the 4 asthma phenotypes. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Asthma
What is being tested?: Bronchoscopsy and Prednisolone
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 2 sitesUnited States
Study dates: 18 Feb 2006to 7 Jul 2011
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female subjects aged between 18-60 years inclusive at screening.
A female subject of childbearing potential must be using effective contraceptive
measures described in protocol for at least one month prior to Screening and should continue using the same contraceptive measure during the study until completion of follow-up procedures. Non child-bearing potential is defined as pre-menopausal females with documented (medical report verification) hysterectomy or surgical sterilisation, or post-menopausal women who have been amenorrheic for more than 1 year and having estradiol and FSH levels consistent with menopause.). Other methods include male partner who is sterile prior to female subject's entry into study and is the sole sexual partner for that female subject.
Atopic or non-atopic subjects
Able to comprehend the nature of this research protocol and other relevant medical information and the ability to give written informed consent prior to participation in the study.
Able to comply with the requirements and restrictions listed in the consent form.

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Available to complete the study and all measurements.
Read, comprehend, and write English at a sufficient level to complete study related materials.
Additional inclusion criteria for the steroid naïve intermittent asthmatics - Cohort A
Have a pre-history of a physician's diagnosis of asthma, with exclusion of other significant pulmonary
No significant disease other than asthma.
No history of steroid myopathy.
No history of recent exposure to live vaccine in the past 4 weeks and no intention to undergo live vaccination during the prednisolone trial or during the month following the trial.
Intermittent asthma with FEV1 ≥ 80% predicted.
Positive beta agonist reversibility as shown by greater than 12% improvement on FEV1or greater than 200ml improvement in FEV1 within 30 minutes following the administration of Albuterol Inhalation Aerosol OR a positive PC20 to Methacholine Challenge smaller than 16 mcg.
Not currently taking inhaled steroids (ICS), and has not taken ICS for at least 6 months prior to screening.
A non-smoker (as demonstrated by a negative urine cotinine) for at least the past 12 months with a pack history ≤5 pack years.
Additional inclusion criteria for the mild to moderate persistent asthmatics on regular inhaled steroids - Cohort B
Have a pre-history of a physician's diagnosis of asthma, with exclusion of other significant pulmonary diseases
No significant disease other than asthma.
No history of steroid myopathy.
No history of recent exposure to live vaccine in the past 4 weeks and no intention to undergo live vaccination during the prednisolone trial or during the month following the trial.
Mild to moderate persistent asthmatic with FEV1 ≥ 80% predicted
Asthma symptoms ranging from daily to less than once a day
Positive beta agonist reversibility as shown by greater than 12% improvement on FEV1or greater than 200ml improvement in FEV1 within 30 minutes following the administration of Albuterol Inhalation Aerosol OR a positive PC20 to Methacholine Challenge smaller than 16 mcg.
On regular inhaled steroid treatment (from 200-500 mcg FP daily or equivalent). Short and long acting beta-2 agonists, anti-cholinergies, and Leukotriene receptor antagonists are allowed as concurrent medication.
A non-smoker (as demonstrated by a negative urine cotinine) for at least the past 12 months with a pack history ≤5 pack years.
Additional inclusion criteria for the severe persistent asthmatics on maximal therapy; regular oral steroids - Cohort C
Have a pre-history of a physician's diagnosis of asthma, with exclusion of other significant pulmonary diseases
No significant disease other than asthma.
No history of steroid myopathy.
No history of recent exposure to live vaccine in the past 4 weeks and no intention to undergo live vaccination during the prednisolone trial or during the month following the trial.
Severe persistent asthmatic
Subjects should have at least one (if on oral steroids) or two (if only on inhaled steroids) of the following indices:
FEV1 <80% (post bronchodilator) and FEV1/FVC ratio <70% predicted;
Daily symptoms ± nocturnal symptoms as recorded in diary cards during run-in;
severe exacerbations (as defined FACET study Tattersfield 1999) of ≥ twice a year in at least one of the last two years, as recorded in clinical records
Positive beta agonist reversibility as shown by greater than 12% improvement on FEV1 or greater than 200ml improvement in FEV1 within 30 minutes following the administration of Albuterol Inhalation Aerosol OR a positive PC20 to Methacholine Challenge smaller than 16 mcg.
High dose inhaled steroids (≥ to 1000 mcg FP daily or equivalent), oral steroids of ≤ 20mg prednisolone a day or equivalent.
A non-smoker (as demonstrated by a negative urine cotinine) for at least the past 12 months with a pack history ≤5 pack years.
Additional inclusion criteria for the currently smoking, mild to moderate persistent asthmatics on maximal therapy; regular oral steroids - Cohort D
Have a pre-history of a physician's diagnosis of asthma, with exclusion of other significant pulmonary
No significant disease other than asthma.
No history of steroid myopathy.
No history of recent exposure to live vaccine in the past 4 weeks and no intention to undergo live vaccination during the prednisolone trial or during the month following the trial.
Smokers (as demonstrated by a positive urine cotinine) with a pack history >5 pack years
Mild to moderate persistent asthmatic with FEV1 ≥ 80% predicted
Asthma symptoms less than once a day
Positive beta agonist reversibility as shown by greater than 12% improvement on FEV1or greater than 200ml improvement in FEV1 within 30 minutes following the administration of Albuterol Inhalation Aerosol OR a positive PC20 to Methacholine Challenge smaller than 16mcg.
On regular inhaled steroid treatment (200-500 mcg FP daily or equivalent). (NB:
short and long acting beta-2 agonists, anti-cholinergies, and Leukotriene receptor antagonists are allowed as concurrent medication.) Additional inclusion criteria for healthy volunteers, non asthmatic, non smokers - Cohort E Healthy; defined as individuals who are free of significant cardiovascular, pulmonary (e.g. tuberculosis), gastrointestinal, hepatic, endocrine, renal, haematological, neurological and psychiatric disease as determined by medical history, physical examination and clinical chemistry/haematology/urinalysis investigation.
A non-smoker (as demonstrated by a negative urine cotinine) for at least the past 12 months with a pack history ≤5 pack years.

Who cannot join

As a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study.
The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation.
Subject is female who is pregnant or lactating.
Having participated within 30 days or 5 half-lives in a study receiving an investigational drug.
Having participated within 30 days in a study with an invasive procedure.
Donation of a 500 mL of blood within the previous 56 days or intention to donate within 56 days of the end of the last bronchoscopy.

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Evidence of recent infection that would preclude participation in the steroid trial in the judgement of the study physician. The subject may be deferred to later participation. History of abnormal bruising or bleeding.
History of alcohol or drug abuse within five years.
Positive urine test for drugs of abuse including alcohol at screen.
Abnormal (clinically significant) clinical laboratory test results.
Medical history of cirrhosis, hepatitis C or hepatitis B or HIV
Doing night-shift work that will change pattern within at least 5 days prior to study start through the first follow up visit for Cohorts A through D. This does not include the follow up visits at 6 and 12 months.
Female subjects who are unwilling or unable to use an appropriate method of contraception
Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
Concomitant medications that may interfere with study procedures or evaluations.
History of hypersensitivity to any of the following medications: Lidocaine, Fentanyl, Versed, Demerol, Midazolam, Epinephrine, Flumanzenil and Naloxon.
History of hypersensitivity to bronchodilator (such as Albuterol)
ALL WOMEN OF CHILD BEARING POTENTIAL WHO DO NOT WISH TO USE PROTOCOL APPROVED METHODS OF CONTRACEPTION WILL BE EXCLUDED.
Additional exclusion criteria for the steroid naïve intermittent asthmatics - Cohort A
Subject has changed asthma medication within 1 month prior to screening.
Subject had an asthma exacerbation in the previous month.
Known sensitivity or allergy to prednisolone.
History of tuberculosis, glaucoma, epilepsy, severe affective disorder or peptic ulceration.
Current use or use within the previous 1 month of oral corticosteroids.
Current use of any asthma medication except short acting inhaled β2 agonists
Current use of Methotrexate, cyclosporin, PDE inhibitors, azathioprine or other immunosuppressive agents, except steroids.
Additional exclusion criteria for the mild to moderate persistent asthmatics on regular inhaled steroids - Cohort B
Subject has changed asthma medication within 1 month prior to screening.
Subject had an asthma exacerbation in the previous month.
Known sensitivity or allergy to prednisolone.
History of tuberculosis, glaucoma, epilepsy, severe affective disorder or peptic ulceration.
Current use or use within the previous 1 month of oral corticosteroids.
Current use of Methotrexate, cyclosporin, PDE inhibitors, azathioprine or other immunosuppressive agents, except steroids.
Additional exclusion criteria for the severe persistent asthmatics on maximal therapy; regular oral steroids - Cohort C
Subject has changed asthma medication within 1 month prior to screening.
Subject had an asthma exacerbation in the previous month.
Known sensitivity or allergy to prednisolone.
History of tuberculosis, glaucoma, epilepsy, severe affective disorder or peptic ulceration.
Current use or use within the previous 1 month of oral prednisolone or equivalent of greater than 20mg daily.
Current use of Methotrexate, cyclosporin, PDE inhibitors, azathioprine or other immunosuppressive agents, except steroids.
Subjects should avoid any medications that in the opinion of the physician might interfere with either the safety of the subject or the interpretation of the results (e.g.
anti-inflammatory drugs)
Additional exclusion criteria for the currently smoking, mild to moderate persistent currently smoking asthmatics on regular inhaled steroids - Cohort D
Subject has changed asthma medication within 1 month prior to screening.
Subject had an asthma exacerbation in the previous month.
Known sensitivity or allergy to prednisolone.
History of tuberculosis, glaucoma, epilepsy, severe affective disorder or peptic ulceration.
Current use or use within the previous 1 month of oral corticosteroids.
Current use of Methotrexate, cyclosporin, PDE inhibitors, azathioprine or other immunosuppressive agents, except steroids.
Additional exclusion criteria for the healthy volunteers, non asthmatic non smokers - Cohort E The subject has any history of breathing problems in adult life (i.e. history of asthmatic symptoms). Screening lung function tests (FEV1) will be performed to confirm normal lung function parameters (≥80% predicted).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

GSK Investigational Site
Philadelphia, Pennsylvania, 19104
GSK Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Study To Validate Key Therapeutic Targets and Characterise Their Response to Corticosteroids in Multiple Asthma Phenotypes

Conditions: Asthma
Being tested: Bronchoscopsy, Prednisolone
Keywords: Severe Asthma bronchoscopy
Medical subject headings: Asthma

What participants receive

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

BronchoscopsyProcedure or surgery
Healthy and Asthmatic Volunteers
PrednisoloneProcedure or surgery
Asthmatic Volunteers

Study groups in NCT00331058
Study group	Role	What they receive
healthy volunteers	Other	control group not receiving prednisolone Receives: Procedure: Prednisolone
asthmatic volunteers	Other	receive prednisolone for 14-16 days Receives: Procedure: Bronchoscopsy

What is being measured

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

compare key drug targets across 4 asthma phenotypes and healthy subjects
Measured: visits 3 through to and including visit 6
evaluate changes in target expression in response to a 2 week course of corticosteroids across the 4 asthma phenotypes
Measured: visits 3 through to and including visit 6

Secondary outcomes (16)

Histopathology on bronchial biopsies
Measured: visits 3 through to and including visit 6
Cytospins
Measured: visits 3 through to and including visit 6
target protein expression
Measured: visits 3 through to and including visit 6
target expression in the blood
Measured: visits 3 through to and including visit 6
inflammatory markers
Measured: visits 3 through to and including visit 6
lung function
Measured: visits 3 through to and including visit 6
Radiological Parameters
Measured: visits 3 through to and including visit 6
Quality of life (QoL) and symptom scores
Measured: visits 3 through to and including visit 6
Changes in medication
Measured: visits 3 through to and including visit 6
Measures of pulmonary inflammation
Measured: visits 3 through to and including visit 6
Assessments of lung structure
Measured: visits 3 through to and including visit 6
activation state of a signalling pathway
Measured: visits 3 through to and including visit 6
Whole Blood TaqMan and/or transcriptomic analysis
Measured: visits 3 through to and including visit 6
new targets and biomarkers
Measured: visits 3 through to and including visit 6
TaqMan and/or Differential Gene Expression and Proteomics
Measured: visits 3 through to and including visit 6
Pharmacogenomics from blood samples
Measured: visits 3 through to and including visit 6

Timeline

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

18 Feb 20067 Jul 2011

First posted29 May 2006 (estimated)
Study start18 Feb 2006
Primary completion7 Jul 2011
Study completion7 Jul 2011

Why it stopped: The study was truncated due to the long period of enrollment and the collection of a sufficient amount of data that allowed the scientific objectives to be met

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00331058
Sponsor's protocol ID: RES100767
Status last verified: Jun 2017
First submitted: 26 May 2006
Last updated: 28 Jun 2017
Results posted: No
Data monitoring committee: No

Publications

Siddiqui S, Shikotra A, Richardson M, Doran E, Choy D, Bell A, Austin CD, Eastham-Anderson J, Hargadon B, Arron JR, Wardlaw A, Brightling CE, Heaney LG, Bradding P. Airway pathological heterogeneity in asthma: Visualization of disease microclusters using topological data analysis. J Allergy Clin Immunol. 2018 Nov;142(5):1457-1468. doi: 10.1016/j.jaci.2017.12.982. Epub 2018 Mar 14.
PubMed 29550052

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study To Validate Key Therapeutic Targets and Characterise Their Response to Corticosteroids in Multiple Asthma Phenotypes
ClinicalTrials.gov ID: NCT00331058
Acronym / sponsor ID: RES100767
Conditions: Asthma
Keywords: Severe Asthma bronchoscopy
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was truncated due to the long period of enrollment and the collection of a sufficient amount of data that allowed the scientific objectives to be met
Enrolment: 58 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 18 Feb 2006 (actual)
Primary completion: 7 Jul 2011 (actual)
Study completion: 7 Jul 2011 (actual)
First posted: 29 May 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
healthy volunteers	Other	Procedure: Prednisolonecontrol group not receiving prednisolone
asthmatic volunteers	Other	Procedure: Bronchoscopsyreceive prednisolone for 14-16 days

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (52 listed)

Male or female subjects aged between 18-60 years inclusive at screening.
A female subject of childbearing potential must be using effective contraceptive
measures described in protocol for at least one month prior to Screening and should continue using the same contraceptive measure during the study until completion of follow-up procedures. Non child-bearing potential is defined as pre-menopausal females with documented (medical report verification) hysterectomy or surgical sterilisation, or post-menopausal women who have been amenorrheic for more than 1 year and having estradiol and FSH levels consistent with menopause.). Other methods include male partner who is sterile prior to female subject's entry into study and is the sole sexual partner for that female subject.
Atopic or non-atopic subjects
Able to comprehend the nature of this research protocol and other relevant medical information and the ability to give written informed consent prior to participation in the study.

Key exclusion criteria (50 listed)

As a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study.
The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation.
Subject is female who is pregnant or lactating.
Having participated within 30 days or 5 half-lives in a study receiving an investigational drug.
Having participated within 30 days in a study with an invasive procedure.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BronchoscopsyHealthy and Asthmatic Volunteers	Procedure or surgery	asthmatic volunteers
PrednisoloneAsthmatic Volunteers	Procedure or surgery	healthy volunteers

Primary outcome

compare key drug targets across 4 asthma phenotypes and healthy subjects
Time frame: visits 3 through to and including visit 6
evaluate changes in target expression in response to a 2 week course of corticosteroids across the 4 asthma phenotypes
Time frame: visits 3 through to and including visit 6

16 secondary outcomes

Histopathology on bronchial biopsies
Time frame: visits 3 through to and including visit 6
Cytospins
Time frame: visits 3 through to and including visit 6
target protein expression
Time frame: visits 3 through to and including visit 6
target expression in the blood
Time frame: visits 3 through to and including visit 6
inflammatory markers
Time frame: visits 3 through to and including visit 6
lung function
Time frame: visits 3 through to and including visit 6
Radiological Parameters
Time frame: visits 3 through to and including visit 6
Quality of life (QoL) and symptom scores
Time frame: visits 3 through to and including visit 6
Changes in medication
Time frame: visits 3 through to and including visit 6
Measures of pulmonary inflammation
Time frame: visits 3 through to and including visit 6
Assessments of lung structure
Time frame: visits 3 through to and including visit 6
activation state of a signalling pathway
Time frame: visits 3 through to and including visit 6
Whole Blood TaqMan and/or transcriptomic analysis
Time frame: visits 3 through to and including visit 6
new targets and biomarkers
Time frame: visits 3 through to and including visit 6
TaqMan and/or Differential Gene Expression and Proteomics
Time frame: visits 3 through to and including visit 6
Pharmacogenomics from blood samples
Time frame: visits 3 through to and including visit 6

Results and safety

The study was stopped early (reason given: The study was truncated due to the long period of enrollment and the collection of a sufficient amount of data that allowed the scientific objectives to be met). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
Derived from this study: PubMed 29550052Siddiqui S, Shikotra A, Richardson M, Doran E, Choy D, Bell A, Austin CD, Eastham-Anderson J, Hargadon B, Arron JR, Wardlaw A, Brightling CE, Heaney LG, Bradding P. Airway pathological heterogeneity in asthma: Visualization of disease microclusters using topological data analysis. J Allergy Clin Immunol. 2018 Nov;142(5):1457-1468. doi: 10.1016/j.jaci.2017.12.982. Epub 2018 Mar 14.
Results for study RES100767 can be found on the GSK Clinical Study Register.Link provided by the sponsor.

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RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Active, not recruitingPhase 2/3
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Community Acquired Pneumonia (CAP)
RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bronchoscopsy and Prednisolone in people with Asthma, run by GlaxoSmithKline at 2 sites in United States.

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 52 inclusion and 50 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: stopped early, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 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?

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?

compare key drug targets across 4 asthma phenotypes and healthy subjects (time frame: visits 3 through to and including visit 6). The study lists 2 primary outcomes in all. 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 NCT00331058, 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 28 Jun 2017.