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AsthmaNCT03640936

Total IgE (Immunoglobulin E) and Der p 1 (d1) Specific IgE in Induced Sputum in Patients With Allergic and Non-allergic Asthma

An observational study of Asthma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

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

Asthma is a heterogeneous disease, and specifically the phenotype of non-allergic asthma is not yet well defined. Several studies describe this group of patients as having severe asthma, persistent eosinophilia and poor therapeutic response. Among the theories being considered is the role of local IgE. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Asthma
What is being tested?
Induced Sputum
How many people
32 participants
Where
1 siteSpain
Study dates
Feb 2015to 1 Feb 2019
Phase
Observational
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients diagnosed with asthma without evidence of allergic disease.

Who may be able to join

  • Age 18-70
  • Asthma according to GEMA (spanish asthma guideline)

Who cannot join

  • Pregnancy
  • Active smoking
  • Moderate alcohol consumption
  • Atopic dermatitis
  • Other respiratory disease different than asthma (COPD, bronchiectasis, cystic fibrosis, pleural disease, interstitial disease)
  • Treatment with steroids or inmunodepressants
  • Active malignancy.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.

    Barcelona, 08041

Other trials in Spain

About this study

Official title: Total IgE and Der p 1 (d1) Specific IgE in Induced Sputum in Patients With Allergic and Non-allergic Asthma

Asthma is a heterogeneous disease, and specifically the phenotype of non-allergic asthma is not yet well defined. Several studies describe this group of patients as having severe asthma, persistent eosinophilia and poor therapeutic response. Among the theories being considered is the role of local IgE. Objectives: 1) To perform a pilot test to validate the measurement technique and standardize the levels of total IgE and IgE specific to Dermatophagoides pteronyssinus (d1) in the induced sputum of asthmatic patients and healthy volunteers. 2) Correlate local total IgE and specific IgE levels to d1 (sputum and peripheral blood) in patients with allergic and non-allergic asthma. 3) Describe the clinical and inflammatory characteristics of patients with allergic and non-allergic asthma.

Read the detailed description

Comparative cross-sectional study. It will include 32 allergic and non-allergic asthma patients and 10 healthy volunteers. All patients will have an induced sputum, pulmonary function studies, FENO (exhaled fraction of nitric oxide), total and specific IgE measurement at d1 (the most common perennial pneumoallergen) in blood and induced sputum, as well as a prick skin test with standardized allergen extracts. Measurement of total IgE and IgE for d1 in induced sputum will be performed in the supernatant and by the ImmunoCAP (Phadia ThermoFisher Scientific) immunofluoroassay technique.

Conditions
Asthma
Being tested
Induced Sputum
Keywords
asthma, allergy, specific IgE
Medical subject headings
Asthma, Hypersensitivity

What participants receive

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

  • Induced SputumBehavioural

    Total IgE and Specific IgE to Dermatophagoides pteronyssinus in Induced Sputum

Study groups in NCT03640936
Study groupRoleWhat they receive
HealthyHealthy controls, without asthma or allergy (negative prick test)
Receives: Behavioral: Induced Sputum
Allergic asthmaPatients with allergic asthma sensitized to Dermatophagoides pteronyssinus, tested by prick test or specific IgE
Receives: Behavioral: Induced Sputum
Non-allergic asthmaPatients with asthma not sensitized to Dermatophagoides pteronyssinus, with negative prick test or specific IgE
Receives: Behavioral: Induced Sputum

What is being measured

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

  1. Levels of specific IgE

    Detection of high levels or not of specific IgE in induced sputum

    Measured: 8 months

Secondary outcomes (1)

  1. Levels of total IgE

    Detection of high levels or not of total IgE in induced sputum

    Measured: 8 months

Timeline

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

  1. First posted21 Aug 2018
  2. Study startFeb 2015
  3. Primary completion1 Feb 2017
  4. Study completion1 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03640936
Sponsor's protocol ID
IIBSP-ASM-2014-66
Status last verified
Jul 2019
First submitted
17 Aug 2018
Last updated
12 Jul 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Johansson SG, Bieber T, Dahl R, Friedmann PS, Lanier BQ, Lockey RF, Motala C, Ortega Martell JA, Platts-Mills TA, Ring J, Thien F, Van Cauwenberge P, Williams HC. Revised nomenclature for allergy for global use: Report of the Nomenclature Review Committee of the World Allergy Organization, October 2003. J Allergy Clin Immunol. 2004 May;113(5):832-6. doi: 10.1016/j.jaci.2003.12.591.

    PubMed 15131563

  • Wenzel SE. Asthma phenotypes: the evolution from clinical to molecular approaches. Nat Med. 2012 May 4;18(5):716-25. doi: 10.1038/nm.2678.

    PubMed 22561835

  • Crespo A, Giner J, Torrejon M, Belda A, Mateus E, Granel C, Torrego A, Ramos-Barbon D, Plaza V. Clinical and inflammatory features of asthma with dissociation between fractional exhaled nitric oxide and eosinophils in induced sputum. J Asthma. 2016 Jun;53(5):459-64. doi: 10.3109/02770903.2015.1116086. Epub 2016 Jan 19.

    PubMed 26785727

  • Rondon C, Campo P, Zambonino MA, Blanca-Lopez N, Torres MJ, Melendez L, Herrera R, Gueant-Rodriguez RM, Gueant JL, Canto G, Blanca M. Follow-up study in local allergic rhinitis shows a consistent entity not evolving to systemic allergic rhinitis. J Allergy Clin Immunol. 2014 Apr;133(4):1026-31. doi: 10.1016/j.jaci.2013.10.034. Epub 2013 Dec 13.

    PubMed 24332860

  • Baba S, Kondo K, Toma-Hirano M, Kanaya K, Suzukawa K, Ushio M, Suzukawa M, Ohta K, Yamasoba T. Local increase in IgE and class switch recombination to IgE in nasal polyps in chronic rhinosinusitis. Clin Exp Allergy. 2014;44(5):701-12. doi: 10.1111/cea.12287.

    PubMed 24931597

  • Pin I, Gibson PG, Kolendowicz R, Girgis-Gabardo A, Denburg JA, Hargreave FE, Dolovich J. Use of induced sputum cell counts to investigate airway inflammation in asthma. Thorax. 1992 Jan;47(1):25-9. doi: 10.1136/thx.47.1.25.

    PubMed 1539140

  • Margarit G, Belda J, Juarez C, Martinez C, Ramos A, Torrejon M, Granel C, Casan P, Sanchis J. [Total IgE in the sputum and serum of patients with asthma]. Allergol Immunopathol (Madr). 2005 Jan-Feb;33(1):48-53. doi: 10.1157/13070609. Spanish.

    PubMed 15777524

  • Korn S, Haasler I, Fliedner F, Becher G, Strohner P, Staatz A, Taube C, Buhl R. Monitoring free serum IgE in severe asthma patients treated with omalizumab. Respir Med. 2012 Nov;106(11):1494-500. doi: 10.1016/j.rmed.2012.07.010. Epub 2012 Aug 11.

    PubMed 22884459

  • Vega JM, Badia X, Badiola C, Lopez-Vina A, Olaguibel JM, Picado C, Sastre J, Dal-Re R; Covalair Investigator Group. Validation of the Spanish version of the Asthma Control Test (ACT). J Asthma. 2007 Dec;44(10):867-72. doi: 10.1080/02770900701752615.

    PubMed 18097865

  • Plaza Moral V; Comite Ejecutivo de GEMA. [GEMA(4.0). Guidelines for Asthma Management]. Arch Bronconeumol. 2015 Jan;51 Suppl 1:2-54. doi: 10.1016/S0300-2896(15)32812-X. Epub 2015 Nov 30. No abstract available. Spanish.

    PubMed 26707419

  • Crespo-Lessmann A, Curto E, Mateus E, Soto L, Garcia-Moral A, Torrejon M, Belda A, Giner J, Ramos-Barbon D, Plaza V. Total and specific immunoglobulin E in induced sputum in allergic and non-allergic asthma. PLoS One. 2020 Jan 29;15(1):e0228045. doi: 10.1371/journal.pone.0228045. eCollection 2020.

    PubMed 31995587

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

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 2 inclusion and 7 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 12 Jul 2019. 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 Spain. 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.

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?

Levels of specific IgE (time frame: 8 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 NCT03640936, which also lists 11 linked publications.

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 12 Jul 2019.

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