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Trial record 73 of 58361 for:    Placebo

Low Exhaled NO and ICS in Suspected Asthma (LowNO)

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ClinicalTrials.gov Identifier: NCT02771717
Recruitment Status : Unknown
Verified May 2016 by University of Nottingham.
Recruitment status was:  Not yet recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Budesonide (Pulmicort) Drug: Placebo - dummy inhaler Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does a Low Exhaled Nitric Oxide Level Exclude a Clinical Benefit From Inhaled Corticosteroids in Suspected Asthma: A Randomised, Placebo Controlled Trial
Study Start Date : May 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: Budesonide (Pulmicort)
Low dose inhaled corticosteroid.
Drug: Budesonide (Pulmicort)
Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily

Placebo Comparator: Placebo - dummy inhaler
Placebo - dummy inhaler
Drug: Placebo - dummy inhaler
Placebo - dummy inhaler to be taken 1 puff twice daily.
Other Name: Placebo




Primary Outcome Measures :
  1. 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. [ Time Frame: overall 12 weeks ]
    Data will be collect via questionnaire at each visit. A change in ACQ-7 of 0.5 is considered clinically important.


Secondary Outcome Measures :
  1. Difference in FEV1 between inhaled steroid and placebo groups adjusted for differences in baseline. [ Time Frame: overall 12 weeks ]
    FEV1 will be measured in Litres.

  2. Measure cough symptoms with the LCQ between ics and placebo group adjusted for differences in baseline. [ Time Frame: 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.

  3. Difference in a subjective measurement of MRC dyspnoea scale. [ Time Frame: overall 12 weeks ]
    This is a subjective scale of breathlessness graded 1-5 (5 being most breathless). This will be assessed from baseline measurements.


Other Outcome Measures:
  1. The incidence of asthma exacerbations will be recorded for each group and compared. [ Time Frame: 12 weeks ]
    The number of asthma exacerbations will be captured from verbal feedback from specific patient questioning at study visits.

  2. The deterioration in asthma control as measured by ACQ-7 and compared between groups. [ Time Frame: 12 weeks ]
    deterioration in asthma control will be captured from the ACQ- 7



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771717


Contacts
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Contact: Tim Harrison, MD tim.harrison@nottingham.ac.uk
Contact: Angela Shone angela.shone@nottingham.ac.uk

Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Tim Dr Harrison, MD University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02771717     History of Changes
Other Study ID Numbers: 16013
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists