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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01343745 |
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Date of registration:
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21/04/2011 |
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Primary sponsor: |
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Public title:
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Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI)
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Scientific title:
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Dose Response Evaluation of CHF 1535 HFA pMDI in Asthmatic Patients Using Lung Function, Adenosine Monophosphate Bronchial Challenge and Fractional Exhaled Nitric Oxide (FENO) |
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Date of first enrolment:
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February 2008 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01343745 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Brian J O'Connor, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Heart Lung Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male and female patients 18-50 years of age, who have signed an informed consent
form.
2. Clinical evidence of asthma
3. Steroid naïve asthmatic patients
4. FEV1 at Screening Visit is >70 % of the predicted value and at least 2.0 L.
5. Body Mass Index between 18 and 35.
6. Sensitivity to AMP at Screening Visit.
7. FENO levels >25 ppb at the Screening Visit
Exclusion Criteria:
1. Having received an investigational product within 2 months of Screening Visit.
2. Inability to comply with study procedures or with study treatment intake.
3. Any significant lung disease which is considered by the investigator to be clinically
significant.
4. Patients who suffer from Chronic Obstructive Pulmonary Disease (COPD)
5. Previous or current smokers who have a smoking history greater than 5 pack years.
6. Patients with any uncontrolled disease that might, in the judgment of the
investigator, place the patients at undue risk or potentially compromise the results
or interpretation of the study.
7. Patients with QTc >450msec at the Screening Visit.
8. Patients with serum potassium <3.5 mEq/L or >6 mEq/L.
9. Intolerance/hypersensitivity or any contra-indication to treatment with
beta2-agonists and/or inhaled corticosteroids.
10. Patients who have a history of alcohol or substance abuse that in the opinion of the
Investigator may be of clinical significance.
11. Patients who have undergone major surgery in the previous 3 months.
12. Patients who have had an exacerbation of asthma, requiring treatment with oral
steroids during the last month prior to Screening Visit.
13. Patients treated with slow-release corticosteroids 2 months prior to Screening Visit.
14. Patients currently treated with anti-IgE Antibodies.
15. Patients who have had a respiratory tract infection within 4-weeks prior to Screening
Visit.
16. Females not willing to use effective contraceptive measures such as oral
contraceptive or intra-uterine device (IUD).
17. Females who are pregnant, lactating or planning to become pregnant
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mild Persistent Asthma
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Intervention(s)
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Drug: BDP/formoterol
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Drug: Placebo
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Primary Outcome(s)
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Fractional Exhaled Nitric Oxide (FeNO)
[Time Frame: 4 h post dose]
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Lung function
[Time Frame: from 0 to 4 h post dose]
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PC20 after AMP challenge
[Time Frame: 4 h post dose]
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Secondary Outcome(s)
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FENO
[Time Frame: 2 h post dose]
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Secondary ID(s)
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2007-004345-14
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FB/PS/14/169/07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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