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Idiopathic Pulmonary FibrosisPhase 1NCT02058602

Inhalation Profiling of Idiopathic Pulmonary Fibrosis (IPF) Patients

A Phase 1 study testing Assessment of Idiopathic Pulmonary Fibrosis over a period of up to 6 months in people with Idiopathic Pulmonary Fibrosis, run by GlaxoSmithKline at 1 site in Belgium.

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 is a clinical study to characterise the lung function, airway morphometry, pharyngometry and inhalation profiles in patients with mild to severe Idiopathic Pulmonary Fibrosis (IPF) over a period of up to 6 months. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
Assessment of Idiopathic Pulmonary Fibrosis over a period of up to 6 months
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteBelgium
Study dates
3 Dec 2013to 11 Jul 2016
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males/females aged 40 years and over, at the time of signing the informed consent.
  • A female patient is eligible to participate if she is of: Non child-bearing potential, where females are post-menopausal, defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milliinternational units per milliliter (MlU/mL) and estradiol < 40 picograms per mililiter (pg/mL) (<147 pmol/L) is confirmatory. Peri-menopausal or pre-menopausal, and have a negative pregnancy test as determined by serum or urine human chorionic gonadotropin (hCG) test, confirmed at screening, and then at each subsequent clinic visit before the CT scanning is conducted.
  • BMI within the range 18 - 32 kilogram per meter^2 (kg/m^2) (inclusive).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Patients will have a diagnosis of IPF as determined by a responsible and experienced Respiratory physician and based on established criteria defined by the American Thoracic Society/European Respiratory Society: American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias.
  • Patient's lung function measurements of Forced vital capacity (FVC) and Diffusing capacity of the Lung for Carbon Monoxide (DLCO) at screening must fall within the category below to be included in this study: FVC >=40 % predicted and DLCO >=30 % predicted.

Who cannot join

  • Patients with a current Idiopathic Pulmonary Fibrosis (IPF) exacerbation.
  • Patients with a known underlying cause of pulmonary fibrosis.
  • Patients that have both IPF and Chronic obstructive pulmonary disease (COPD) that requires therapy with more than an intermittent bronchodilator or a long acting muscarinic antagonist, or where the Forced Expiratory Volume in One Second (FEV1)/ Forced vital capacity (FVC) ratio is <0.65.
  • Patients with an upper or lower respiratory tract infection within four weeks of Visit 1.
  • Patients with a recognised co-existing respiratory disorder other than usual interstitial pneumonia (UIP) (e.g. significant COPD, asthma, sarcoid, lung carcinoma) that in the opinion of the investigator would confound the study outcomes.
  • Patients with poorly controlled left ventricular heart failure.
Show all 18Show fewer
  • Serious or uncontrolled medical, surgical or psychiatric disease that in the opinion of the investigator would compromise patient safety or confound the study data (e.g. congestive cardiac failure [CCF], asthma, angina, neurological disease, liver dysfunction and blood dyscrasia).
  • Patients found to have clinically significant anaemia until adequately treated.
  • Patients that have a history of alcohol abuse.
  • Patients who are currently taking Pirfenidone for IPF or who have received Pirfenidone within the previous 30 days prior to Visit 1.
  • Patients with previous exposure to ionising radiation > 5 millieSievert (mSv) in the 3 years prior to enrolment (not including ionising radiation used for therapeutic or diagnostic purposes or for purposes that involve patient benefit).
  • Patients who have a history of claustrophobia.
  • As a result of the medical history, physical examination or screening investigations, the physician responsible considers the patient unfit for the study.
  • The patient is unable or unwilling to perform study assessments and procedures correctly.
  • The patient has received an investigational drug for IPF within 30 days of the start of the study.
  • A requirement for long-term oxygen therapy (LTOT) as defined by the prescription of oxygen to be used for greater than or equal to 12 hours of therapy per day. Note - short burst oxygen therapy is permitted.
  • Patient is kept under regulatory or judicial order in an institution.
  • Patient is mentally or legally incapacitated.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • GSK Investigational Site

    Edegem, 2650

Other trials in Belgium

About this study

Official title: A Study to Characterise Lung Function, Airway Morphometry, Pharyngometry and Inhalation Profiles From Patients With Idiopathic Pulmonary Fibrosis (IPF)

This is a clinical study to characterise the lung function, airway morphometry, pharyngometry and inhalation profiles in patients with mild to severe Idiopathic Pulmonary Fibrosis (IPF) over a period of up to 6 months. Inhalation profiles will be recorded from patients with IPF as they inhale during tidal breathing, and following two sets of instructions (maximal effort and 'long, steady and deep' inhalation), across a range of airflow resistances that reflect those of typical inhalers used to deliver medication to the lungs. Mouth and throat dimensions will be measured using an acoustic reflectance Pharyngometer. Measurements of lung function will be made using conventional sprirometry, plethysmography and diffusion, whilst Low Dose High Resolution Computed Tomography (HRCT) will be used to scan the airways at two lung volumes; functional residual capacity (FRC) and total lung capacity (TLC). Data from HRCT will be used to reconstruct airway morphometry, and model inhaled particle deposition within the lung. Overall, the study allows a further understanding of the IPF patient population, using the data to assist in the development of new inhaled products for this disease. Following up the patients with additional HRCT scans at 3 and 6 months will enable the sensitivity of CT based criteria of disease progression to be compared with lung function criteria. No investigational product will be used in this study.

Being tested
Assessment of Idiopathic Pulmonary Fibrosis over a period of up to 6 months
Keywords
HRCT, Airway morphometry, Resistivity, Inhalation Profiles, Inhaler, Pharyngometry, Idiopathic Pulmonary Fibrosis (IPF)
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

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

  • Assessment of Idiopathic Pulmonary Fibrosis over a period of up to 6 monthsOther

    Patients are receiving no treatment on this study and there is no investigational product involved.

Study groups in NCT02058602
Study groupRoleWhat they receive
Arm 1ExperimentalThis is a clinical study to characterise the lung function, airway morphometry, pharyngometry and inhalation profiles in patients with mild to severe Idiopathic Pulmonary Fibrosis (IPF) over a period of up to 6 months. Approximately 30 subjects will be enrolled so that at least 20 subjects complete all critical assessments.
Receives: Other: Assessment of Idiopathic Pulmonary Fibrosis over a period of up to 6 months

What is being measured

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

  1. To characterise the inhalation profiles

    Inhalation profile was characterised by assessing Peak pressure Drop (kPa), Peak Inspiratory Flow Rate (L/min), Inhaled Volume (L), Inhalation time (s), Average Inhalation Flow Rate (L/min), Acceleration rate (L/min/s)

    Measured: Up to 6 months

  2. To characterise the pharyngometry

    The pharyngometry characters were assessed by Distance (cm), Volume (cm^3), Average cross sectional area (cm^2).

    Measured: Up to 6 months

  3. Mouth and throat measurements from HRCT scan reconstruction

    Mouth and throat measurements from HRCT scan reconstruction assessing Length (mm), Minimum cross-sectional area square millimetre(mm^2), Average cross-sectional area (mm^2), Concavity, Volume (mm^3)

    Measured: Up to 6 months

  4. Lung measurements from HRCT scan

    Lung measurements from HRCT scan by assessing Volume, length, direction and diameter of each airway branch at FRC and TLC, Lobar volumes at FRC and TLC, Relative lobar growth from FRC to TLC, Total lung volume at FRC and TLC

    Measured: Up to 6 months

Secondary outcomes (1)

  1. To explore the relationship between changes in airway morphometry determined by HRCT and measures of spirometry, diffusion and plethysmography

    Lung function by spirometry (FVC, FEV1, Vmax25 and 50, PEFR and PIFR)

    Measured: Up to 6 months

Timeline

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

  1. First posted10 Feb 2014 (estimated)
  2. Study start3 Dec 2013
  3. Primary completion11 Jul 2016
  4. Study completion11 Jul 2016

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02058602
Sponsor's protocol ID
117275
Status last verified
May 2018
First submitted
6 Feb 2014
Last updated
17 May 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Assessment of Idiopathic Pulmonary Fibrosis over a period of up to 6 months in people with Idiopathic Pulmonary Fibrosis, run by GlaxoSmithKline at 1 site in Belgium.

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 6 inclusion and 18 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 17 May 2018. 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 Belgium. 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?

To characterise the inhalation profiles (time frame: Up to 6 months). The study lists 4 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 NCT02058602.

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 17 May 2018.

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