Comparison of effectiveness of two different kinds of inhalers on bronchodilation in people with asthma

• Register: EUCTR
• Last refreshed on: 7 December 2015
• Main ID: EUCTR2014-002705-38-BG
• Date of registration: 03/11/2014
• Prospective Registration: Yes
• Primary sponsor: Orion Corporation Orion Pharma
• Public title: Comparison of effectiveness of two different kinds of inhalers on bronchodilation in people with asthma
• Scientific title: STUDY COMPARING BRONCHODILATOR EFFICACY OF TWO DRY POWDER INHALERS, BUDESONIDE/FORMOTEROL EASYHALER AND SYMBICORT TURBUHALER; A RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, MULTICENTRE, SINGLE DOSE, CROSSOVER STUDY IN ASTHMATIC SUBJECTS - BUFODIL
• Date of first enrolment: 22/12/2014
• Target sample size: 72
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002705-38
• 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: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 4

Countries of recruitment

Bulgaria, Hungary

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Orion Corporation Orion Pharma

• Name: Clinical Trial Information Desk
• Affiliation: Orion Corporation Orion Pharma

Key inclusion & exclusion criteria

Inclusion criteria:
1. Written informed consent (IC) obtained
2. Male or female subjects aged 18-70 (inclusive) years on the screening visit.
3. Documented diagnosis of asthma for ? 6 months. The asthma diagnosis should be in accordance with the latest international recommendations provided by the Global Initiative for Asthma (GINA).
4. Prebronchodilator FEV1 45-90% (inclusive) of the predicted value measured on screening visit.
5. Demonstration of reversible airway obstruction: ? 12% and ? 200 ml improvement in FEV1 after inhalation of SABA within 6 months prior to screening or at the screening visit.
6. Demonstration of stepwise reversibility of airway obstruction with formoterol. Overall improvement in FEV1 at least 15% after 6 + 42 µg (metered dose, 4.5 + 31.5 µg as delivered dose) of formoterol inhaled via Turbuhaler, with a 50% additional improvement seen after the second dose.
7. Asthma should be stable on the same regular treatment (e.g. inhaled corticosteroid) for at least 4 weeks before the screening visit.
8. Asthma unlikely to exacerbate during the study (e.g. because of seasonal allergen exposure).
9. Non-smoker for at least 6 months before the screening visit.
10. Ability to use Easyhaler and Turbuhaler according to instructions.

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 72
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Hypersensitivity to any components of the preparations, i.e., budesonide, formoterol fumarate dihydrate or lactose (which contains small amounts of milk proteins).
2. Treatment with LABA within 4 weeks before screening visit and during the study.
3. Treatment with xanthine-derivatives (e.g. theophylline) within 4 weeks before screening visit and during the study.
4. Use of ß -blocker within 4 weeks preceding screening visit and during the study.
5. Use of quinidine, disopyramide, procainamide, phenothiazines, terfenadine, astemizole, diphenhydramine, monoamine oxidase inhibitors, tricyclic antidepressants and use of any other drug that prolongs the QT-interval during the study.
6. Use of oral, parenteral, rectal or systemic corticosteroids within 4 weeks preceding screening visit and during the study.
7. Respiratory infection within 4 weeks preceding screening visit.
8. Smoking history of more than 10 pack-years (the equivalent of one pack per day for 10 years).
9. Abnormal ECG of clinical significance and/or corrected QT interval (calculated with the Fridericia formula [QTcF]) > 450 ms in males or > 470 ms in females on screening visit.
10. Cardiovascular, renal, neurological, liver or endocrine dysfunction or any other major concurrent illness that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the patient if he/she takes part in the study.
11. Chronic bronchitis or any other severe chronic respiratory disease other than asthma. History of cystic fibrosis or bronchiectasis.
12. Abnormal serum potassium value or other clinically significant laboratory findings on the screening visit.
13. Systolic blood pressure (BP) over 180 mmHg and/or diastolic BP over 100 mmHg at rest on the screening visit.
14. Pregnant, breast-feeding or fertile women without reliable contraception (mechanical and/or hormonal contraception, intrauterine device [IUD] or surgical sterilisation). Double method of contraception is needed when using oral or mechanical contraception; e.g. condom in conjunct with oral contraception and spermicidal product with mechanical contraception. Females of childbearing potential with no current sexual relationship can be included without contraception according to the judgement of the investigator.
15. Investigator’s suspicion of alcohol or drug abuse.
16. Previous participation in this study or participation in another clinical drug study within 4 weeks before the first study treatment administration and during the study.



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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Asthma
MedDRA version: 17.1 Level: LLT Classification code 10006070 Term: Br. asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 17.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Trade Name: SYMBICORT TURBUHALER
Product Name: SYMBICORT TURBUHALER
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Budesonide
CAS Number: 51333-22-3
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 320-
INN or Proposed INN: Formoterol
CAS Number: 183814-30-4
Other descriptive name: FORMOTEROL FUMARATE HYDRATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use

Trade Name: Bufomix Easyhaler
Product Name: Bufomix Easyhaler
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 320-
INN or Proposed INN: Formoterol
CAS Number: 183814-30-4
Other descriptive name: Formoterol fumarate hydrate
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Primary end point(s): The primary efficacy variable is the average of 12-hour FEV1.

Secondary Objective: Not applicable

Main Objective: The objective of the study is to confirm equivalent bronchodilator efficacy of the test product (Budesonide/formoterol Easyhaler) compared to the reference product (Symbicort Turbuhaler).

Timepoint(s) of evaluation of this end point: The spirometry test will be performed on each study treatment day before and 10, 20, 60, 120, 180, 240, 360, 480, 600 and 720 min after administration of the study treatment (counted from the start of the first inhalation)

Secondary Outcome(s)

Secondary end point(s): Maximum FEV1 over the 12-hour serial assessments and FEV1 at 12 hours post-dose (i.e. FEV1 at the trough of the effect) will be the secondary efficacy variables.

Timepoint(s) of evaluation of this end point: The spirometry test will be performed on each study treatment day before and 10, 20, 60, 120, 180, 240, 360, 480, 600 and 720 min after administration of the study treatment (counted from the start of the first inhalation)

Secondary ID(s)

2014-002705-38-HU

3103013

Source(s) of Monetary Support

Orion Corporation Orion Pharma