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Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2004-001724-20-HU
Date of registration:	30/08/2004
Prospective Registration:	Yes
Primary sponsor:	AstraZeneca AB
Public title:	A randomised, placebo-controlled, double-blind, double-dummy, crossover study to assess the onset of action of two inhalations of Symbicort 160/4.5µg compared with two inhalations of Seretide 25/250µg, two inhalations of Ventoline 100µg, and placebo, delivered by pressurised metered dose inhalers, in patients with chronic obstructive pulmonary disease (COPD). - OSSCAR
Scientific title:	A randomised, placebo-controlled, double-blind, double-dummy, crossover study to assess the onset of action of two inhalations of Symbicort 160/4.5µg compared with two inhalations of Seretide 25/250µg, two inhalations of Ventoline 100µg, and placebo, delivered by pressurised metered dose inhalers, in patients with chronic obstructive pulmonary disease (COPD). - OSSCAR
Date of first enrolment:	08/10/2004
Target sample size:
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001724-20
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: yes Other trial design description: double dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no
Phase:

Countries of recruitment
Hungary

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
1. Outpatients of either gender ³ 40 years of age.
2. Clinical diagnosis of COPD, with COPD symptoms for more than 2 years (COPD diagnosis according to GOLD guideline).
3. Smoking, current or previous with a smoking history ³ 10 pack years.
4. Pre-bronchodilatory FEV1 30-70% of predicted normal value.
5. Pre-bronchodilatory FEV1/VC £70 %
6. Reversibility, 9-25% of predicted normal FEV1 value.
7. Ability to use pressurised metered dose inhaler correctly.
8. Signed written informed consent from the patient.
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. A history of asthma.
2. Allergic rhinitis with symptoms within the last 20 years.
3. Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator.
4. Any current respiratory tract disorders other than COPD, which is considered by the investigator to be clinically significant.
5. Any significant disease or disorder (e.g. pulmonary other than COPD, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patients ability to participate in the study.
6. Exacerbation of COPD within 30 days prior to Visit 1 and/or during run-in requiring hospitalisation, a course of antibiotics and/or oral steroids, and/or increased doses of inhaled steroids and/or parenteral treatment and/or nebulized treatment.
7. A requirement for regular use of oxygen therapy.
8. Use/need of b-blocking agents.
9. Scheduled in-patient hospitalisation during the course of the study.
10. Participation in or scheduled for an intensive COPD rehabilitation program.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

This is an application for a phase III study to be conducted in COPD patients.
Classification code 10010952

Intervention(s)

Trade Name: Symbicort pMDI 160/4.5mcg/actuation
Product Name: Symbicort pMDI 160/4.5mcg
Product Code: N/A
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: budesonide
CAS Number: 51333-22-3
Concentration unit: µg microgram(s)
Concentration number: 160-120
INN or Proposed INN: formoterol dihydrate
CAS Number: 43229-80-7
Concentration unit: µg microgram(s)
Concentration number: 4.5-120
Pharmaceutical form of the placebo: Pressurised inhalation, suspension
Route of administration of the placebo: Inhalation use

Trade Name: Seretide Evohaler
Product Name: Seretide Evohaler
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: salmeterol xinofoate
CAS Number: 89365-50-4
Concentration unit: µg microgram(s)
Concentration number: 25-120
INN or Proposed INN: fluticasone propionate
CAS Number: 94749-08-3
Concentration unit: µg microgram(s)
Concentration number: 250-120
Pharmaceutical form of the placebo: Pressurised inhalation, suspension
Route of administration of the placebo: Inhalation use

Trade Name: Ventolin Evohaler
Product Name: Ventolin Evohaler
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: salbutamol sulfate
Concentration unit: µg microgram(s)
Concentration number: 100-100
Pharmaceutical form of the placebo: Pressurised inhalation, suspension
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Primary end point(s): Change in forced expiratory volume in one second (FEV1), 5 minutes after dose.

Secondary Objective: - To study efficacy of two inhalations of Symbicort 160/4.5µg compared with two inhalations of Seretide 25/250µg, two inhalations of Ventoline 100µg, and placebo, by the Perception of Onset of Effect questionnaire (POE) and inspiratory capacity.

- To investigate safety of two inhalations of Symbicort 160/4.5µg compared with two inhalations of Seretide 25/250µg, two inhalations of Ventoline 100µg, and placebo, by assessing the nature, incidence and severity of adverse events (AEs).

Main Objective: To evaluate efficacy i.e. to study the bronchodilatating effect within the first 180 minutes after two inhalations of Symbicort 160/4.5µg compared with two inhalations of Seretide 25/250µg, two inhalations of Ventoline 100µg, and placebo, delivered by pressurised metered dose inhalers, in patients with chronic obstructive pulmonary disease (COPD).

Secondary Outcome(s)

Secondary ID(s)

D5899C00748

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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