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Cystic FibrosisPhase 3PsAer-IgYNCT01455675

Efficacy Study of IgY (Antibody Against Pseudomonas) in Cystic Fibrosis Patients

A Phase 3 study testing IgY in people with Cystic Fibrosis, run by Mukoviszidose Institut gGmbH at 42 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to prolong the time to reinfection with Pseudomonas aeruginosa after successfully treated acute or intermittent infection. Read more about this study

Who is it for?
Ages 5 years and older
Conditions the study is for
Cystic Fibrosis
What is being tested?
IgY
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
164 participants
Where
42 sitesin 9 countries
Study dates
Oct 2011to 27 Jun 2017
Phase
Phase 3
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 5 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • CF patients diagnosed according to specific clinical features and either a positive sweat chloride in double proofs or presence of disease-associated CFTR mutations in both alleles
  • Males and females 5 years of age and above (being able to gargle)
  • CF patients having a FEV1 value between 50% and 130% of predicted value (according to Knudson formula)
  • CF patients who have had one to several sputum or throat cough swabs or endolaryngeal suction cultures positive for PA within the last three years and for whom PA has been successfully eradicated.
  • Sputum / throat cough swab/ endolaryngeal suction culture negative for PA and other gram-negative bacteria on study entry.
  • Patients and/ or their legal representative who are willing and able to give informed consent/ assent to participate in the study after thorough information
  • Subjects of child bearing potential and who are sexually active must meet the contraception requirements (i.e. oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms).

Who cannot join

  • Microbiologic or serologic evidence of chronic infection with PA. Definition of chronic PA infection: Three cultures (sputum or throat cough swabs or endolaryngeal suction) have been positive for PA for 6 consecutive months (at least 3 cultures have to be taken) or more, .
  • Patients, who have positive sputum culture or throat cough swab or endolaryngeal suction culture for gram-negative bacteria, such as PA, S. maltophilia, B. cepacia, A. xylosoxidans (eradication before entry in study is possible), Patients, who have positive sputum culture or throat cough swab or endolaryngeal suction culture for atypical Mycobacteria and / or Aspergillus fumigates, associated with clinical symptoms that may necessitate specific treatment.
  • History of allergy/hypersensitivity to hens' egg proteins (including medication allergy) that is deemed relevant to the trial by the investigator. "Relevance" in this context refers to any increased risk of hypersensitivity reaction to trial medication.
  • Patient with a known relevant substance abuse, including alcohol or drug abuse.
  • Start of a new concomitant or chronic medication for CF within 4 weeks before inclusion.
  • Clinically relevant diseases or medical conditions other than CF or CF-related conditions that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data. This includes, but is not limited to, significant hematological, hepatic, renal, cardiovascular, and neurological diseases (diabetic patients may participate if their disease is under good control prior to inclusion).
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  • Participation in another study with an investigational drug within one month or 6 half-lives (whichever is greater) preceding the inclusion.
  • The patient is an employee of the investigator or the institution with direct involvement in the trial or other trials under the direction of the investigator or their members.
  • Patients who are pregnant cannot be included into the study. This will be tested at inclusion visit with a urine pregnancy test (in female patients older than 10 years with secondary sexual characteristics)

Trial locations and contacts

42 sites in 9 countries.

42 sites in 9 countries

Germany16 sites

  • Charité, Christiane Herzog Zentrum

    Berlin, 13353

  • Klinikum der Ruhr Universität Bochum

    Bochum, 44791

  • Universitätsklinik Köln

    Cologne, 50924

  • University Dresden

    Dresden, 01307

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Universitätsklinikum Essen

    Essen, 45122

  • Klinikum der Johann-Wolfgang- Goethe Universität Frankfurt

    Frankfurt

  • Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen, 35392

  • MH Hannover (adults)

    Hanover, 30625

  • MH Hannover (children)

    Hanover, 30625

  • Universitätsklinik Jena, Mukoviszidosezentrum

    Jena, 07740

  • Städtisches Krankenhaus Kiel GmbH

    Kiel, 24116

  • Universitätsklinikum Mainz

    Mainz, 55131

  • Universitätsklinik Tübingen

    Tübingen, 72076

  • Universitäts-Kinderklinik Würzburg

    Würzburg, 97080

Other trials in Germany

Poland5 sites

  • Szpital Dzieciecy Polanki im. Macieja Plazynskiego w Gdansku sp Z o.o. Poradnia Leczenia

    Gdansk, 80-308

  • Centrum Medyczne Karpacz Spólka Akcyjna

    Karpacz, 58-540

  • Wojewódzki Szpital Specjalistyczny im. M.Kopernika Ośrodek Pediatryczny im. dr J.Korczaka

    Lodz, 90-329

  • NZOZ Sanatorium Cassia Villa Medica

    Rabka-Zdrój, 34-700

  • Instytut Matki i Dziecka Zaklad Mukowiscydozy

    Warsaw, 01-211

Other trials in Poland

Ireland4 sites

  • Cork University Hospital

    Cork

  • Our Lady´s Children´s Hospital

    Dublin, 12

  • Tallagh Hospital

    Dublin, 24

  • Mid-Western Regional Hospital

    Limerick

Other trials in Ireland

Italy4 sites

  • Centro Regionale Toscano di Riferimento per la Fibrosi Cistica

    Florence, 50139

  • Istituto Ospedale Giannina Gaslini

    Genova, 16100

  • Centro Regionale Fibrosi Cisica Lazio

    Roma, 00161

  • Azienda Ospedaliera Universitaria Integrata di Verona

    Verona, 37126

Other trials in Italy

Spain4 sites

  • Hospital Universitario Cruces Neumologia, Pediatric pulmonology

    Barakaldo (Vizcaya), 48903

  • Passeig Vall d´Hebron 119

    Barcelona, 08035

  • Hospital Infantil la Paz Sección de Neumologia Pediátrica

    Madrid, 28046

  • Hospital Materno-Infantil Servicio de Pediatria

    Málaga, 29011

Other trials in Spain

Belgium3 sites

  • Clinic of Pediatric Respiratory Diseases, Infectious Diseases and Travel Clinic

    Brussels, 1090

  • Hôpital Universitaire Erasme, Service de Pneumologie

    Brussels

  • University Hospital Leuven, Kindergeneeskunde

    Leuven, 3000

Other trials in Belgium

Austria2 sites

  • Medizinische Universität Innsbruck Department für Kinderheilkunde, Päd III CF Zentrum

    Innsbruck, 6020

  • (SALK) Universitätsklink für Kinder- und Jugendheilkunde, Ambulanz für Allergien und Lungenerkrankungen

    Salzburg, 5020

Other trials in Austria

Hungary2 sites

  • Heim Pal Hospital for Children

    Budapest, 1089

  • Országos Korányi TBC és Pulm. Intézet, XIX. J fsz. Kronikus-CF care

    Budapest, 1121

Other trials in Hungary

Sweden2 sites

  • Karolinska University Hospital, Huddinge - CF-Centre

    Stockholm, 141 86

  • Uppsala University Childrens Hospital, Akademiska sjukhuset, CF center

    Uppsala, 75185

Other trials in Sweden

About this study

Official title: Phase III Study to Evaluate Clinical Efficacy and Safety of Avian Polyclonal Anti-Pseudomonas Antibodies (IgY) in Prevention of Recurrence of Pseudomonas Aeruginosa Infection in Cystic Fibrosis Patients

The purpose of this study is to prolong the time to reinfection with Pseudomonas aeruginosa after successfully treated acute or intermittent infection.

Read the detailed description

This is a double -blind, placebo controlled study in which the investigational drug and the reference placebo group are gargled and swallowed. 70 ml IgY/ placebo solution is gargled every night for two minutes (for maximal 24 months) The design will include the recruitment of 144 patients randomized in two groups (72 per treatment group) In order to compensate for dropouts (i.e. patients dropping out prior to 24 months without having an event) the total sample size was planned to be approximately 180 (i.e. ~20 % dropout rate). After the actual drop-out rate has been low throughout the study, only 144 plus approx. 10% potential drop-outs were included into the study.

During the two years of treatment, subjects will be examined at the clinic every 3 months regarding safety and efficacy of the medication.

For more information please see www.impactt.eu The IMPACTT Project is funded by EU within the Framework 7 Program. PsAer-IgY Studies is part of IMPACTT Project (Workpackage 2).

Conditions
Cystic Fibrosis
Being tested
IgY, Placebo
Keywords
cystic fibrosis
Medical subject headings
Cystic Fibrosis

What participants receive

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

  • IgYDrug

    Also called PsAer-IgY

    Avian polyclonal anti-pseudomonas antibodies (IgY)

  • PlaceboDrug

    Placebo, 70 ml gargling solution, once daily

Study groups in NCT01455675
Study groupRoleWhat they receive
IgY, gargling solutionExperimentalAvian polyclonal anti-pseudomonas antibodies (IgY), 70 ml gargling solution contains 50 mg IgY with an activity against PA, once daily
Receives: Drug: IgY
Placebo, gargling solutionPlacebo comparator70 ml gargling solution without antibodies, once daily
Receives: Drug: Placebo

What is being measured

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

  1. Time from start of treatment (=Day 0) to the first recurrence of PA (Pseudomonas aeruginosa) in the sputum or throat cough swab or endolaryngeal suction

    Measured: max. 24 months

Secondary outcomes (8)

  1. • Change in FEV 1.0 from day 0 to each visit

    Measured: max. 24 months

  2. • Change in BMI from day 0 to each visit

    Measured: max. 24 months

  3. • Number of exacerbations

    Measured: max. 24 months

  4. • Number of days of illness in hospital and at home, i.e. out of school or work

    Measured: max. 24 months

  5. • Control of use of antibiotics, especially anti-pseudomonas antibiotics -measured as days with antibiotic treatment

    Measured: max. 24 months

  6. • Change in values of serologic tests for PA precipitins from day 0 to each visit (if applicable)

    Measured: max. 24 months

  7. • Good tolerability and comparable number and quality of adverse events like placebo group

    Measured: max. 24 months

  8. • Sputum or throat cough swab or endolaryngeal suction cultures for bacteria and fungi

    Measured: max. 24 months

Timeline

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

  1. First posted20 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completion27 Jun 2017
  4. Study completion27 Jun 2017

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01455675
Sponsor's protocol ID
PsAer-IgY
Acronym
PsAer-IgY
Status last verified
Jul 2017
First submitted
18 Oct 2011
Last updated
6 Jul 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IgY in people with Cystic Fibrosis, run by Mukoviszidose Institut gGmbH at 42 sites in 9 countries.

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 7 inclusion and 9 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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Germany, Poland, Ireland, Italy, Spain and 4 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Time from start of treatment (=Day 0) to the first recurrence of PA (Pseudomonas aeruginosa) in the sputum or throat cough swab or endolaryngeal suction (time frame: max. 24 months). 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 NCT01455675.

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 6 Jul 2017.

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