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    EudraCT Number:2013-004404-19
    Sponsor's Protocol Code Number:Acadmed18013
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-03-25
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-004404-19
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Crossover Study to
    Assess the Effect of 28 Day Treatment with Fostair® pMDI 200/12 on biomarkers of platelet adhesion in Patients with Idiopathic pulmonary fibrosis.

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Fostair® on biomarkers of platelet adhesion in Idiopathic pulmonary fibrosis
    A.3.2Name or abbreviated title of the trial where available
    Effect of Fostair® pMDI on biomarkers of platelet adhesion in IPF
    A.4.1Sponsor's protocol code numberAcadmed18013
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02048644
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHull and East Yorkshire Hospitals NHS Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support chiesi ltd
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHull and East Yorkshire Hospitals NHS Trust
    B.5.2Functional name of contact pointWright
    B.5.3 Address:
    B.5.3.1Street AddressRespiratory Medicine
    B.5.3.2Town/ cityCastle Hill Hospital, Cottingham
    B.5.3.3Post codeHU16 5JQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01482624067
    B.5.5Fax number01482624068
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D. name Fostair
    D. of the Marketing Authorisation holderChiesi Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN beclometasone dipropionate
    D.3.9.1CAS number 5534-09-8
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNformoterol fumarate dihydrate
    D.3.9.1CAS number 183814-30-4
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number24
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPressurised inhalation, solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic pulmonary fibrosis
    E.1.1.1Medical condition in easily understood language
    chronic fibrosis of the lung
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    There is a significant unmet medical need for the treatment of Idiopathic pulmonary fibrosis (IPF); there is no effective therapy for treatment of IPF in the UK, and only pirfenidone is approved for treatment. The main goal of the current study is to evaluate the effect of Fostair on the biomarkers of platelet activation in IPF disease. We believe that platelets- cell fragments which have a major role in wound healing, also have a pivotal role in the pathogenesis of IPF and whether this translates in to a clinically beneficial effect of Fostair on IPF disease.

    The primary objective of this study is to determine the effect of Fostair fine particle Metered dose inhaler on markers of pulmonary fibrosis. Primary endpoint will be a change in biomarkers of platelet activation.
    E.2.2Secondary objectives of the trial
    Secondary end points: will be change in lung function as well as other clinical measures such as acute exacerbations, respiratory hospitalisations, six minute walking distance (6MWD), mean weekly activity as measured by a Sense wear® arm band, any change in sputum inflammatory cells, the alveolar fraction of exhaled NO, and quality of life as measured by KBILD questionnaire.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects from 40 to 85 years of age
    2. Diagnosis of definite IPF according to ATS/ERS Consensus Statement (2011) using either HRCT or surgical lung biopsy (SLB).
    2.TLco of ≥ 30 % predicted ( historical measure accepted as long as within the last year).
    3. Able to maintain O2 saturation of ≥ 89% while breathing room air at rest.
    4. FVC of 50-80% predicted value
    5. Negative serum pregnancy test at screening and negative urine pregnancy test at randomisation for female subjects of childbearing potential.
    6. Competency to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved Informed Consent Form (ICF); subjects must sign the form prior to the initiation of any study procedures, unless the assessment is performed as standard of care for this disease.
    E.4Principal exclusion criteria
    1. Clinically significant respiratory diseases other than IPF, including asbestosis, other pneumoconiosis or hypersensitivity pneumonitis.
    2. Clinically significant heart disease defined as a myocardial infarction documented by an ST elevation (STEMI) on electrocardiogram (ECG) within 6 months prior to screening, percutaneous coronary intervention or coronary artery bypass surgery within 6 months prior to screening, unstable angina pectoris, congestive heart failure (NYHA class III/IV or known left ventricular ejection fraction < 25%),ischaemic heart disease, right heart failure, significant right ventricular hypertrophy, or uncontrolled arrhythmia.
    3. Current smokers
    4. Use of any inhaled long acting beta-agonist or inhaled steroid within the 3 months prior to screening
    5. Use of any medication to or possibly indicated in the treatment of IPF, such as pirfenidone, and oral corticosteroids.
    6. Use of any Antiplatelet therapy which may alter assessment of study end points e.g. clopidogrel, Prasugrel, Dipyridamole etc.
    7. History of cancer, precancerous state (eg, familial polyposis, BRCA1, BRCA2, carcinoma in-situ), other than non-melanomatous skin cancer, within 5 years prior to screening.
    8. History or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion.
    9. Participation in an investigational drug or device trial < 30 days prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the biomarkers for platelet adhesion. Measurements will include platelet-monocyte complex formation, platelet P-selectin expression and platelet fibrinogen binding in the presence of` the platelet agonists ADP ( Adenosine diphosphate) and TFLLR measured at baseline, and post IMP treatments at Visit 5 and visit 8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time points for evaluation will be at baseline visit, 4 weeks post initial treatment and the 4 weeks post second treatment
    E.5.2Secondary end point(s)
    • Change in FVC % predicted from baseline will be expressed as mean (SD) and compared between the two treatment periods using paired ttest.

    • Absolute change in 6MWD from baseline between treatment periods will be expressed as mean (SD) and compared between the two treatment periods using paired ttest.

    •Compare Change in total score on K-BILD questionnaire from baseline between each treatment period and also change in the domains: breathlessness and activities (questions 1, 4, 11, 13), psychological (questions 3, 5, 6, 8, 10, 12, 14) and chest symptoms (questions 2, 7, 9); see Appendix 7
    Scores will be compared using paired ttest a p<0.05 will be considered significant. The minimal important difference will also be identified a minimal important difference of 8 units will be considered significant.

    •Change in Sputum inflammatory cells – inflammatory cell total and differential counts ( % neutrophils, eosinophils, macrophages, epithelial cells and lymphocytes) in sputum samples will be measured at baseline and following each treatment period. Results will be expressed as mean (SEM). For non-parametric data these will be log transformed and expressed as geometric mean (log SEM). Changes in these parameters from baseline will be measured using paired ttest where p<0.05 will be considered significant

    • Change in FeNo
    • Adjudicated acute exacerbations
    • Adjudicated respiratory hospitalizations
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of the secondary endpoints will occur at baseline, at visit 5 and at visit 8
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Fostair is available on prescription howver it is not recommended for the indication of IPF, the patients consultant DR Hart may be able to prescribe Fostair to patients completeing the study under exceptional circumatances, this will need to be reviewed through the drugs and therapeutics board.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation none
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-25
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