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Pulmonary Disease, Chronic ObstructivePhase 1NCT01521390

Assessment of Lung Function After Single Inhalations of a Bronchodilator From 2 Configurations a Dry Powder Inhaler.

A Phase 1 study testing GSK573719 62.5 mcg (one strip), GSK573719 62.5 mcg(two strips) and GSK573719 125 mcg (one strip) in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site 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

GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for the treatment of chronic obstructive pulmonary disease (COPD). The long duration of action of GSK573719, when administered via inhalation to humans supports the potential for use as a long acting… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
GSK573719 62.5 mcg (one strip), GSK573719 62.5 mcg(two strips) and GSK573719 125 mcg (one strip)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteGermany
Study dates
12 Oct 2011to 16 Dec 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • 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.
  • Healthy male or female as determined by a responsible and experienced physician, based on a medical evaluation including [medical history, physical examination, laboratory tests and cardiac monitoring]. A subject with a clinical significant abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator believes that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • 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 (<147 pmol/L) is confirmatory]. [Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must 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.]
  • 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 10 days after last dose.
  • Body weight ≥ 50 kg and BMI within the range 19.0 - 29.9 kg/m2 (inclusive).
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  • Normal spirometry (FEV1 ≥ 80% of predicted, FEV1/FVC ≥ 70%).
  • Response to ipratropium bromide defined as
  • an increase in sGaw of ≥25% over pre-dose baseline at 2 h following 80μg ipratropium bromide; or
  • a documented increase in sGaw of ≥25% over pre-dose baseline at 2 h following inhalation of 80 μg of ipratropium bromide within 3 months of screening.
  • AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • No significant abnormality on 12-lead ECG at screening, including QTcF < 450msec.
  • Non-smokers (never smoked or not smoking for >6 months with <10 pack years history (Pack years = (cigarettes per day smoked/20) x number of years smoked))
  • Subjects who are able to use the Novel DPI satisfactorily
  • Subjects, who are capable of giving written informed consent, have signed and dated the informed consent form which includes compliance with the requirements and restrictions listed in the consent form.

Who cannot join

  • A supine mean heart rate outside the range 40-90 beats per minute (BPM) at screening.
  • A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHG) at screening.
  • History of symptomatic arrhythmias.
  • 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.
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  • 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.
  • History of sensitivity to any of the study medications, 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.
  • Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
  • Lactating females.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subject is mentally or legally incapacitated.
  • Subject who has asthma or a history of asthma or bronchoconstriction.
  • Urinary cotinine levels indicative of smoking or history or regular use of tobacco or nicotine-containing products within 6 months prior to screening.
  • Subjects who are kept due to regulatory or juridical order in an institution.
  • Subjects who are in military service.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • GSK Investigational Site

    Berlin, 14050

Other trials in Germany

About this study

Official title: Randomized, Double-blind, 5 Period Cross Over Study Assessing Lung Function in Healthy Volunteers Following Single Inhalations of GSK573719 Inhalation Powder From Two Configurations of the Novel Dry Powder Inhaler

GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for the treatment of chronic obstructive pulmonary disease (COPD). The long duration of action of GSK573719, when administered via inhalation to humans supports the potential for use as a long acting bronchodilator.This is a randomized, double-blind, placebo-controlled, 5 period cross-over study in healthy male and female volunteers. The study will measure lung function after single inhaled doses from two configurations of the Novel Dry Powder Inhaler. Key assessments will include clinical relevant PD parameters: sGaw, FEV1

Being tested
GSK573719 62.5 mcg (one strip), GSK573719 62.5 mcg(two strips), GSK573719 125 mcg (one strip), GSK573719 125 mcg(two strips), Placebo
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.

  • GSK573719 62.5 mcg (one strip)Drug

    GSK573719 62.5 mcg delivered by 1 strip configuration of novel dry powder inhaler

  • GSK573719 62.5 mcg(two strips)Drug

    GSK573719 62.5 mcg delivered by 2 strip configuration of novel dry powder inhaler

  • GSK573719 125 mcg (one strip)Drug

    GSK573719 125 mcg delivered by 1 strip configuration of novel dry powder inhaler

  • GSK573719 125 mcg(two strips)Drug

    GSK573719 125 mcg delivered by 2 strip configuration of novel dry powder inhaler

  • PlaceboDrug

    Placebo, no active ingredient

Study groups in NCT01521390
Study groupRoleWhat they receive
Treatment ArmOtherSubjects receive one inhalation from each intervention
Receives: Drug: GSK573719 62.5 mcg (one strip); Drug: GSK573719 62.5 mcg(two strips); Drug: GSK573719 125 mcg (one strip); Drug: GSK573719 125 mcg(two strips); Drug: Placebo

What is being measured

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

  1. Weighted mean and maximal change from baseline in sGaw

    measured by plethysmography, for each inhaled dose from one strip configuration as compared with two strip

    Measured: serial over 24 hr for each treatment period

Secondary outcomes (8)

  1. Plasma concentration of GSK573714

    Pharmacokinetic parameters

    Measured: over 24 hrs for each treatment period

  2. Urine concentration of GSK573714

    Pharmacokinetic parameters

    Measured: over 24 hr for each treatment period

  3. Blood pressure

    Measured: over 24 hr for each treatment period

  4. Heart Rate

    Measured: over 24 hr for each treatment period

  5. Serial FEV1

    Measured: over 24 hr

  6. Serial sGaw

    Measured: over 24 hr for each treatment period

  7. ECG

    12-lead ECG

    Measured: over 24 hrs for each treatment period

  8. Clinical lab safety tests

    Haematology, Biochemistry and Urinalysis

    Measured: Over 24 hrs for each treatment period

Timeline

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

  1. First posted30 Jan 2012 (estimated)
  2. Study start12 Oct 2011
  3. Primary completion16 Dec 2011
  4. Study completion16 Dec 2011

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01521390
Sponsor's protocol ID
115487
Status last verified
Jun 2017
First submitted
26 Jan 2012
Last updated
20 Jun 2017
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK573719 62.5 mcg (one strip), GSK573719 62.5 mcg(two strips) and GSK573719 125 mcg (one strip) in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site 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 15 inclusion and 22 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 20 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 1 site 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 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?

Weighted mean and maximal change from baseline in sGaw (time frame: serial over 24 hr for each treatment period). 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 NCT01521390.

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 20 Jun 2017.

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