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Low Exhaled NO and ICS in Suspected Asthma (LowNO)

12. maj 2016 opdateret af: University of Nottingham

Does a Low Exhaled Nitric Oxide Level Exclude a Clinical Benefit From Inhaled Corticosteroids in Suspected Asthma: A Randomised, Placebo Controlled Trial

The purpose of this study is to determine whether a low exhaled nitric oxide reading (<27ppb) is a good predictor of a negative response to inhaled steroid treatment for patients with symptoms suggestive of asthma.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

At the first visit, which will take place at either at the GP surgery or the Nottingham Respiratory Research Unit (NRRU) informed written consent for the study will be obtained. The patients will then have an exhaled NO measurement, spirometry, venepuncture (for Full Blood Count and research blood - if consent obtained) taken and complete an Asthma Control Questionnaire (ACQ), Medical Research Council dyspnoea scale (MRC) and Leicester Cough Questionnaire (LCQ). All procedures will be carried out by the NRRU research nurse.

The investigators may use the NRRU existing database of research volunteers to recruit as necessary and also the respiratory clinics held at the NUH. If patients from clinics are recruited they will be initially approached by their usual care doctor and an information sheet will be sent / given to them accordingly.

If all the inclusion criteria are met and none of the exclusion criteria, the patients will be randomised to receive either a placebo inhaler, to be taken one puff twice daily, or a low dose inhaled steroid treatment, Budesonide 200mcgs via Turbuhaler one puff twice daily, for 3 months. Dr Tim Harrison will be prescribing the inhalers and they will be dispensed from the Nottingham City Hospital Clinical Trials Pharmacy and delivered/given to the patient by the research nurses.

Participants will be asked to return for follow up visits at 4 weeks, 8 weeks and 12 weeks following randomisation. At these follow up visits, exhaled NO, spirometry and the 3 questionnaires will be repeated.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

165

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Aged 18 years or over.
  2. Asthma suspected by GP/Practice Nurse
  3. Must be able to give informed consent
  4. Exhaled Nitric Oxide reading <27ppb
  5. FEV1 >70% predicted

Exclusion Criteria:

  1. Patients requiring oral steroid treatment on visit to GP/Practice nurse
  2. Use of oral prednisolone or antibiotics within last 4 weeks
  3. Already using an inhaled corticosteroid
  4. Any other clinically significant co-morbidity.
  5. Expectant or breast feeding mothers.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Budesonide (Pulmicort)
Low dose inhaled corticosteroid.
Medicin: Budesonide (Pulmicort)
Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily
Placebo komparator: Placebo - dummy inhaler
Medicin: Placebo - dummy inhaler
Placebo - dummy inhaler to be taken 1 puff twice daily.
Andre navne:
  • Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in Asthma Control Questionnaire (ACQ-7) between the inhaled steroid and placebo group adjusted for differences in baseline. The ACQ will measure the level of asthma control in the ICS and placebo group.
Tidsramme: overall 12 weeks
Data will be collect via questionnaire at each visit. A change in ACQ-7 of 0.5 is considered clinically important.
overall 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in FEV1 between inhaled steroid and placebo groups adjusted for differences in baseline.
Tidsramme: overall 12 weeks
FEV1 will be measured in Litres.
overall 12 weeks
Measure cough symptoms with the LCQ between ics and placebo group adjusted for differences in baseline.
Tidsramme: overall 12 weeks
A minimal important difference in LCQ is 1.3. This will be assessed using this validated, self-reported measure of quality of life for cough.
overall 12 weeks
Difference in a subjective measurement of MRC dyspnoea scale.
Tidsramme: overall 12 weeks
This is a subjective scale of breathlessness graded 1-5 (5 being most breathless). This will be assessed from baseline measurements.
overall 12 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The incidence of asthma exacerbations will be recorded for each group and compared.
Tidsramme: 12 weeks
The number of asthma exacerbations will be captured from verbal feedback from specific patient questioning at study visits.
12 weeks
The deterioration in asthma control as measured by ACQ-7 and compared between groups.
Tidsramme: 12 weeks
deterioration in asthma control will be captured from the ACQ- 7
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Nottingham

Efterforskere

  • Ledende efterforsker: Tim Dr Harrison, MD, University of Nottingham

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2016

Primær færdiggørelse (Forventet)

1. juli 2017

Studieafslutning (Forventet)

1. juli 2018

Datoer for studieregistrering

Først indsendt

28. april 2016

Først indsendt, der opfyldte QC-kriterier

12. maj 2016

Først opslået (Skøn)

13. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 16013

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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