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Efficacy and Tolerability of Beclomethasone Plus Salbutamol in HFA pMDI Fixed Combination vs Beclomethasone Plus Salbutamol in CFC pMDI Fixed Combination in a 12-week Treatment Period of Adult Patients With Uncontrolled Asthma

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ClinicalTrials.gov Identifier: NCT00528723
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : March 30, 2017
Sponsor:
Information provided by:
Chiesi Farmaceutici S.p.A.

Tracking Information
First Submitted Date  ICMJE September 11, 2007
First Posted Date  ICMJE September 12, 2007
Last Update Posted Date March 30, 2017
Study Start Date  ICMJE November 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2007)
Mean value of morning PEF (daily measured by the patient) [ Time Frame: last 2 weeks treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2007)
  • Morning PEF daily measured by the patient at any other time point [ Time Frame: last 2 weeks treatment ]
  • Evening PEF, and morning and evening FEV1 daily measured by the patient [ Time Frame: all treatment period (12 weeks), at each two weeks ]
  • Pulmonary function parameters (FEV1, FVC, PEF and FEF25-75%) [ Time Frame: clinic visits ]
  • Changes from pre-dosing of pulmonary function parameters measured at in the interval 0-60 minutes (pre-dose and 5, 15, 30 and 60 minutes post-dose); [ Time Frame: baseline (visit 2) and end of treatment (visit 6) ]
  • Rates of asthma exacerbations (in total and by severity) [ Time Frame: all treatment period, at each two weeks ]
  • Time to first asthma exacerbation [ Time Frame: all treatment period, at each two weeks ]
  • Night-time and daytime use of relief salbutamol, and number of days (both day and night) without intake of salbutamol [ Time Frame: all treatment period, at each two weeks ]
  • Nighttime and daytime symptoms scores, and number of symptoms-free days (both day and night) [ Time Frame: all treatment period, at each two weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerability of Beclomethasone Plus Salbutamol in HFA pMDI Fixed Combination vs Beclomethasone Plus Salbutamol in CFC pMDI Fixed Combination in a 12-week Treatment Period of Adult Patients With Uncontrolled Asthma
Official Title  ICMJE Multicentre, Multinational, Randomised, Double Blind, Double Dummy, Active Drug Controlled, Parallel Group Study Design Clinical Trial of the Efficacy and Tolerability of Beclomethasone Dipropionate 250 mcg Plus Salbutamol 100 mcg in HFA pMDI Fixed Combination vs. Beclomethasone Dipropionate 250 mcg Plus Salbutamol 100 mcg in CFC pMDI (Clenil® Compositum 250) Fixed Combination in a 12-week Treatment Period of Adult Patients With Uncontrolled Asthma
Brief Summary The purpose of this trial is to verify if the test treatment BDP 250 mcg/salbutamol 100 mcg HFA pMDI fixed combination is non-inferior to BDP 250 mcg/salbutamol 100 mcg pMDI fixed combination given with the conventional CFC propellant (Clenil® Compositum 250, Chiesi Farmaceutici) in terms of Pulmonary Function (morning PEF).
Detailed Description

Asthma is a chronic inflammatory disorder of the airways and a serious public health worldwide problem, affecting people of all ages, with an estimate of 300 millions affected individuals.When uncontrolled, asthma can place severe limits on daily life, and can sometimes be fatal.

There are two major classes of inhaled therapy for the treatment of reversible obstructive airways disease: antinflammatory agents and bronchodilators. In particular, BDP 250 mcg plus salbutamol 100 mcg in fixed combination is an effective and safe method to control symptoms of persistent asthma in adults.

This study has been designed to compare the efficacy, safety and tolerability of a new BDP 250 mcg/salbutamol 100 mcg HFA pMDI fixed combination with the same CFC-formulated fixed combination, which is on the market from some decades.The HFA propelled product is developed to replace the CFC formulation already marketed according to the European Union's Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (III/5378/93 - Final) in order to prevent from depletion of stratospheric ozone.

The primary objective of this trial is to demonstrate that the test treatment BDP 250 mcg/salbutamol 100 mcg HFA pMDI fixed combination is non-inferior to BDP 250 mcg/salbutamol 100 mcg pMDI fixed combination given with the conventional CFC propellant (Clenil® Compositum 250, Chiesi Farmaceutici) in terms of Pulmonary Function (morning PEF).

Given the aim of the study, the population to be monitored includes adult patients with persistent asthma according to the current guidelines. The treatment period will be preceded by a 2-week run-in period. Subjects satisfying all the inclusion and exclusion criteria will then enter the 12-week treatment period. Clinic visits will take place at the start and end of the run-in period, and after 2, 4, 8 and 12 weeks after randomisation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bronchial Asthma
Intervention  ICMJE
  • Drug: salbutamol 100 mcg
    To be used as needed for symptom relief
    Other Name: Ventolin®
  • Drug: BDP/salbutamol HFA pMDI
    Patients assigned to BDP/salbutamol HFA pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative CFC placebo
  • Drug: BDP/salbutamol CFC pMDI
    Patients assigned to BDP/salbutamol CFC pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative HFA placebo
    Other Name: Clenil® Compositum 250
Study Arms  ICMJE
  • Experimental: A
    BDP/salbutamol HFA pMDI
    Interventions:
    • Drug: salbutamol 100 mcg
    • Drug: BDP/salbutamol HFA pMDI
  • Active Comparator: B
    BDP/salbutamol CFC pMDI
    Interventions:
    • Drug: salbutamol 100 mcg
    • Drug: BDP/salbutamol CFC pMDI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 11, 2007)
180
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Written informed consent obtained,
  2. Male or female out-patients aged ³ 18 and < 65 years;
  3. Uncontrolled asthma defined according to the GINA 2006 "Classification of Levels of Asthma Control". This definition includes the presence of two or more of the following features (in addition to the required range of FEV1): a) daytime asthma symptoms > twice a week; b) any limitation of activities; c) any nocturnal symptoms/awakening; b) need for reliever/rescue treatment > twice a week. These conditions are to be based on recent medical history and are to be confirmed in the 2-week run-in period;
  4. Forced expiratory volume in the first second (FEV1) ³ 60% and < 80% of the predicted normal value;
  5. Positive response to the reversibility test in the screening visit, defined as an increase of at least 12% (or, alternatively, of 200 mL) from pre-bronchodilator value in the measurement of FEV1 30 minutes following 4 puffs (4 ´ 100 µg) of inhaled salbutamol administered via pMDI. The reversibility test can be avoided in patients having a documented positive response in the previous 6 months;
  6. Non-smokers or ex-smokers with a cumulative tobacco exposure less than 5 pack-years and who have stopped smoking since more than 1 year;
  7. A co-operative attitude and ability to be trained to correctly use the pMDIs;
  8. At the end of the 2-week run-in period, the condition of uncontrolled asthma (see inclusion criteria No. 3) is to be confirmed by reviewing the diary cards for run-in.

Exclusion Criteria:

  1. Inability to carry out pulmonary function testing;
  2. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD;
  3. History of near fatal asthma;
  4. Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks;
  5. Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months;
  6. Patients who have been treated with an inhaled corticosteroid in the previous 4 weeks;
  7. Patients who have been treated with nebulized, oral, intravenous or intramuscular corticosteroids in the past 8 weeks or depot injectable corticosteroids in the past 12 weeks;
  8. Patients who have been treated with a long-acting β2-agonist (LABA) in the past 2 weeks;
  9. Patients who have been treated with an oral β2-agonist in the past 48 hours;
  10. Patients who have been treated with a short-acting β2-agonist (SABA) in the past 6 hours;
  11. Patients who have been treated with nebulized bronchodilators in the past 2 weeks;
  12. Patients who have been treated with anticholinergic medications (by any route) in the past 2 weeks;
  13. Patients who have been treated with a xanthine derivative (by any route) in the past 4 weeks;
  14. Patients who have been treated with an inhaled cromone or a leukotriene modifier in the past 4 weeks;
  15. History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias;
  16. Diabetes mellitus;
  17. Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass graft (CABG) during the previous six months;
  18. Patients with an abnormal QTc interval value in the ECG test, defined as > 450 msec in males or > 470 msec in females;
  19. Patients with a serum potassium value ≤ 3.5 mEq/L (or 3.5 mmol/L) and/or fasting serum glucose value ≥ 140 mg/dL (or 7.77 mmol/L);
  20. Other haemodynamic relevant rhythm disturbances (including atrial flutter or atrial fibrillation with ventricular response, bradycardia (≤ 55 bpm), evidence of atrial-ventricular (AV) block on ECG of more than 1st degree;
  21. Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism, significant hepatic impairment, poorly controlled pulmonary (tuberculosis, active mycotic infection of the lung), gastrointestinal (e.g. active peptic ulcer), neurological or haematological autoimmune diseases;
  22. Cancer or any chronic diseases with prognosis < 2 years;
  23. Pregnant or lactating females or females at risk of pregnancy, i.e. those not demonstrating adequate contraception (i.e. barrier methods, intrauterine devices, hormonal treatment or sterilization).
  24. History of alcohol or drug abuse;
  25. Patients treated with monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers as regular use;
  26. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients;
  27. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
  28. Patients who received any investigational new drug within the last 12 weeks;
  29. Patients who have been previously enrolled in this study;
  30. At the end of the run-in period, patients will not be admitted to the treatment period in the case of an increase of FEV1 measured at the clinics at the end of the run-in period ³ 15% in respect of the pre-bronchodilator value measured at the start of the run-in period;
  31. Patients with asthma exacerbations during the run-in period will also be excluded from the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Russian Federation,   Spain,   Ukraine
Removed Location Countries Poland
 
Administrative Information
NCT Number  ICMJE NCT00528723
Other Study ID Numbers  ICMJE MC/PR/033004/002/06
2007-002816-25 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nicolini Gabriele, Chiesi Farmaceutici
Study Sponsor  ICMJE Chiesi Farmaceutici S.p.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Giovanni Cremonesi, M D Chiesi Farmaceutici S.p.A.
Study Director: Gabriele Nicolini, CPM Chiesi Farmaceutici S.p.A.
Principal Investigator: Luis Puente, Dr Hospital General Universitario Gregorio Maranon, Madrid
Principal Investigator: Giorgio Walter Canonica, Prof. Ospedale S.Martino e Cliniche Universitarie Convenzionate, Genova, Italy
Principal Investigator: Igor Bereznyakov, Prof. Department of therapy of Kharkov Academy of Postgraduate Education, Kharkov, Ukraine
PRS Account Chiesi Farmaceutici S.p.A.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP