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Note: This record shows only 22 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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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2007-006249-42-GB |
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Date of registration:
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28/12/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase 3, randomised, open-label, cross-over study to compare HFA vs CFC pMDI formulations of budesonide on methacholine hyper-reactivity in patients with stable, persistent, mild to moderate asthma
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Scientific title:
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A Phase 3, randomised, open-label, cross-over study to compare HFA vs CFC pMDI formulations of budesonide on methacholine hyper-reactivity in patients with stable, persistent, mild to moderate asthma |
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Date of first enrolment:
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28/02/2008 |
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Target sample size:
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95 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006249-42 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria:
1.Provision of signed written informed consent before any study-related procedure is initiated
2.Male or female patients between 18 and 65 years of age inclusive.
3.Patients suffering from stable, persistent, mild to moderate asthma as defined by Global Initiative for Asthma (GINA) Guidelines and for whom FEV1 > 60 %
4.ICS taking = 1000 µg BDP per day, or equivalent
5.Methacholine PC20 < 4 mg/mL
6.Ability to inhale from pMDI according to given instructions, as judged by the investigator or study nurse.
For inclusion in the study treatment period subjects must fulfil all of the following criteria:
1.Methacholine PC20 < 4 mg/mL
2.FEV1 at the end of the run-in period > 60% predicted
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1.Known or suspected hypersensitivity to budesonide or any other constituents of the budesonide HFA pMDI or budesonide CFC pMDI.
2.Using any medication that may interfere with the results of the study.
3.Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the study.
4.Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator. Fertile women must show a negative pregnancy test at Visit 1.
5.Currently a smoker or who has ceased smoking within 6 months of Visit 1.
6.Any clinically relevant abnormal laboratory values, as judged by the investigator.
7.Previous allocation of randomization code in this study, for details see also section 3.5 of study protocol
8.Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the screening visit.
9.Patients who are scheduled to receive any other investigational drug during the course of the study.
10.Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.
11.Patients with Chronic Obstructive Pulmonary Disease (COPD) or bronchiectasis
12.Involvement in the planning and conduct of the study (applies to both
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Asthma
MedDRA version: 9.1
Level: LLT
Classification code 10003553
Term: Asthma
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Intervention(s)
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Trade Name: Pulmicort HFA pMDI
Product Name: Pulmicort HFA pMDI
Pharmaceutical Form: Pressurised inhalation, suspension
Pharmaceutical form of the placebo: Pressurised inhalation, suspension
Route of administration of the placebo: Inhalation use
Trade Name: Pulmicort
Product Name: Pulmicort CFC pMDI
Pharmaceutical Form: Pressurised inhalation, suspension
Pharmaceutical form of the placebo: Pressurised inhalation, suspension
Route of administration of the placebo: Inhalation use
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Primary Outcome(s)
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Primary end point(s): The primary efficacy endpoint is the methacholine airway responsiveness measured as PC20. This is recorded at first baseline (the end of the run-in; prior to Treatment 1), during treatment period 1 (i.e., after the first 2 weeks on 200 µg and after the second 2 weeks on 800 µg), at second baseline (the end of the washout; prior to Treatment 2) and during treatment period 2 (i.e., after the first 2 weeks on 200 µg and after the second 2 weeks on 800 µg).
Following a log2 transformation, the change in PC20 from pooled baseline will be compared between treatments at each dose using an Analysis of Variance (ANOVA), with patient, period and treatment in the model.
The HFA and CFC formulations will be compared at each dose level. Other efficacy measures will be analysed using the same model, but without log2 transformation (with the exception for eNO), and 95% confidence intervals for the differences between doses at each level will be calculated. For diary variables, pooled baselines will not be used in the analyses (i.e. these variables will not be expressed as changes from pooled baseline).
Cortisol values will be log-transformed prior to analysis and analysed using the same model as above.
For PC20, the primary analysis will be to estimate the relative dose potency and the 95% confidence interval for the relative dose potency. HFA and CFC formulations will be considered therapeutically equivalent if the confidence interval is contained within 50-200%.
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Secondary Objective: Secondary objectives include assessment of the effect of the two treatments on
· airway responsiveness to methacholine,
· spirometry,
· exhaled nitric oxide ,
· asthma symptoms,
· PEF and the
· ratio of overnight urinary cortisol to creatinine.
Assessment of safety will include reports of serious adverse events and discontinuations due to adverse event.
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Main Objective: The primary objective is to compare the relative dose potency of HFA vs CFC pMDI budesonide on airway responsiveness to methacholine.
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Secondary ID(s)
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D5252C00008
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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