Inhalation Profiling of Idiopathic Pulmonary Fibrosis (IPF) Patients

Last updated: May 14, 2018
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

1

Condition

Cystic Fibrosis

Scar Tissue

Pulmonary Fibrosis

Treatment

N/A

Clinical Study ID

NCT02058602
117275
  • Ages > 40
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 [inquestionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milliinternational units per milliliter (MlU/mL) and estradiol < 40 picograms permililiter (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 chorionicgonadotropin (hCG) test, confirmed at screening, and then at each subsequent clinicvisit 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 therequirements and restrictions listed in the consent form.

  • Patients will have a diagnosis of IPF as determined by a responsible and experiencedRespiratory physician and based on established criteria defined by the AmericanThoracic Society/European Respiratory Society: American Thoracic Society/EuropeanRespiratory Society International Multidisciplinary Consensus Classification of theIdiopathic Interstitial Pneumonias.

  • Patient's lung function measurements of Forced vital capacity (FVC) and Diffusingcapacity of the Lung for Carbon Monoxide (DLCO) at screening must fall within thecategory below to be included in this study: FVC >=40 % predicted and DLCO >=30 %predicted.

Exclusion

Exclusion Criteria:

  • 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) thatrequires therapy with more than an intermittent bronchodilator or a long actingmuscarinic 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

  • Patients with a recognised co-existing respiratory disorder other than usualinterstitial 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.

  • Serious or uncontrolled medical, surgical or psychiatric disease that in the opinionof the investigator would compromise patient safety or confound the study data (e.g.congestive cardiac failure [CCF], asthma, angina, neurological disease, liverdysfunction 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 Pirfenidonewithin the previous 30 days prior to Visit 1.

  • Patients with previous exposure to ionising radiation > 5 millieSievert (mSv) in the 3years prior to enrolment (not including ionising radiation used for therapeutic ordiagnostic 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 procedurescorrectly.

  • The patient has received an investigational drug for IPF within 30 days of the startof the study.

  • A requirement for long-term oxygen therapy (LTOT) as defined by the prescription ofoxygen 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.

Study Design

Total Participants: 25
Study Start date:
December 03, 2013
Estimated Completion Date:
July 11, 2016

Connect with a study center

  • GSK Investigational Site

    Edegem, 2650
    Belgium

    Site Not Available

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