Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI)
NCT ID: NCT01343745
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
18 participants
INTERVENTIONAL
2008-02-29
2008-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo pMDI
Placebo
pressurised metered dose inhaler
Low dose
BDP/formoterol pMDI low dose
BDP/formoterol
pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 1 inhalation bid (total daily dose 200 µg BDP + 12 µg formoterol)
High dose
BDP/Formoterol pMDI high dose
BDP/formoterol
pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 4 inhalations bid (total daily dose 800 µg BDP + 48 µg formoterol)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BDP/formoterol
pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 4 inhalations bid (total daily dose 800 µg BDP + 48 µg formoterol)
BDP/formoterol
pressurised metered dose inhaler, BDP + Formoterol 100/6 µg, 1 inhalation bid (total daily dose 200 µg BDP + 12 µg formoterol)
Placebo
pressurised metered dose inhaler
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brian J O'Connor, MD
Role: PRINCIPAL_INVESTIGATOR
Heart Lung Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Respiratory Clinical Trials - Heart Lung Centre - Queen Anne Street Medical Centre
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
O'Connor BJ, Collarini S, Poli G, Brindicci C, Spinola M, Acerbi D, Barnes PJ, Leaker B. Rapid effects of extrafine beclomethasone dipropionate/formoterol fixed combination inhaler on airway inflammation and bronchoconstriction in asthma: a randomised controlled trial. BMC Pulm Med. 2011 Dec 21;11:60. doi: 10.1186/1471-2466-11-60.
Related Links
Access external resources that provide additional context or updates about the study.
Study Record on EU Clinical Trials Register including results
CSR Synopsis available in the CHIESI Clinical Study Register
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2007-004345-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FB/PS/14/169/07
Identifier Type: -
Identifier Source: org_study_id