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Bronchial AsthmaPhase 3NCT00528723

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

A Phase 3 study testing salbutamol 100 mcg, BDP/salbutamol HFA pMDI and BDP/salbutamol CFC pMDI in people with Bronchial Asthma, run by Chiesi Farmaceutici S.p.A. at 25 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Bronchial Asthma
What is being tested?
salbutamol 100 mcg, BDP/salbutamol HFA pMDI and BDP/salbutamol CFC pMDI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
25 sitesin 4 countries
Study dates
Nov 2007to Jan 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Written informed consent obtained,
  • Male or female out-patients aged ³ 18 and < 65 years;
  • 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;
  • Forced expiratory volume in the first second (FEV1) ³ 60% and < 80% of the predicted normal value;
  • 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;
  • 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;
  • A co-operative attitude and ability to be trained to correctly use the pMDIs;
  • 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.

Who cannot join

  • Inability to carry out pulmonary function testing;
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD;
  • History of near fatal asthma;
  • Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks;
  • Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months;
  • Patients who have been treated with an inhaled corticosteroid in the previous 4 weeks;
Show all 31Show fewer
  • 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;
  • Patients who have been treated with a long-acting β2-agonist (LABA) in the past 2 weeks;
  • Patients who have been treated with an oral β2-agonist in the past 48 hours;
  • Patients who have been treated with a short-acting β2-agonist (SABA) in the past 6 hours;
  • Patients who have been treated with nebulized bronchodilators in the past 2 weeks;
  • Patients who have been treated with anticholinergic medications (by any route) in the past 2 weeks;
  • Patients who have been treated with a xanthine derivative (by any route) in the past 4 weeks;
  • Patients who have been treated with an inhaled cromone or a leukotriene modifier in the past 4 weeks;
  • History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias;
  • Diabetes mellitus;
  • Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass graft (CABG) during the previous six months;
  • Patients with an abnormal QTc interval value in the ECG test, defined as > 450 msec in males or > 470 msec in females;
  • 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);
  • 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;
  • 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;
  • Cancer or any chronic diseases with prognosis < 2 years;
  • 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).
  • History of alcohol or drug abuse;
  • Patients treated with monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers as regular use;
  • Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients;
  • Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
  • Patients who received any investigational new drug within the last 12 weeks;
  • Patients who have been previously enrolled in this study;
  • 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;
  • Patients with asthma exacerbations during the run-in period will also be excluded from the study.

Trial locations and contacts

25 sites in 4 countries.

25 sites in 4 countries

Ukraine14 sites

  • Department of Therapy of Kharkov Medical Academy of Postgraduate Education City Multifield Clinical Hospital n° 25

    Kharkiv, 61008

  • Pulmonological and Allergological Department of the Kharkov Regional Clinical Hospital

    Kharkiv, 61022,

  • Central Military Hospital of North Region. Pulmonological Department

    Kharkiv, 61022

  • Department of propaedeutics of internal diseases #1. Kharkov State Medical University.

    Kharkiv, 61022

  • Pulmonological Department # 2 City Clinical Hospital # 13

    Kharkiv, 61035

  • Pulmonological Department of the Institute of Therapy Ukrainian Academy of Medical Science

    Kharkiv, 61035

  • Department of General Practice - Family Medecine Medical Academy of post-graduate education. City Clinical Hospital N° 17

    Kharkiv, 61037

  • Department of Diagnostic, Therapy and Clinical Pharmacology of Lung Disease of the Institute of Phtisiology and Pulmonology Academy of Medical Sciences of the Ukraine

    Kiev, 03680

  • Institute of Phthisiology and Pulmonology Acedemy of Medical Science of the Ukraine

    Kiev, 03680

  • Pulmonology Department of the Institute of Phthisiology and Pulmonology AMS of the Ukraine

    Kiev, 03680

  • Department of Pediatrics and laboratory diagnostics, Dniepropetrovsk State Medical Academy City Clinical Hospital No. 8. Pulmonology Department. 55

    Krivoi Rog, 50082

  • General Therapy Clinic Central Military Clinical Hospital of Ministry of Defenses of Ukraine

    Kyiv, 01133

  • Department of Hospital Therapy of Lugansk State Medical Institute

    Luhansk, 91045

  • Department of Hospital Therapy, Lviv State Medical University named by Danylo Galytsky, Lviv Regional Clinical Hospital

    Lviv, 79010

Other trials in Ukraine

Italy5 sites

  • Servizio di Fisiopatologia Respiratoria Diagnostica Allergologica e Biologia Respiratoria Endoscopica e Toracica U.O.C. di Pneumologia Ospedale Orlandi

    Bussolengo, (vr), 37012

  • Unità Dipartimentale di Fisiopatologia Respiratoria -Dipartimento di Medicina Interna e Specialità Mediche (DI.MI.) - Ospedale S. Martino e Cliniche Universitarie Convenzionate

    Genova, 16129

  • Unità Operativa Complessa di Clinica fisiologica e Pneumologia - Dipartimento di Medicina Interna e Specialità Mediche (DI.MI.) - Ospedale S. Martino e Cliniche Universitarie Convenzionate

    Genova, 16129

  • Dipartimento di Medicina Ambientale e Sanità Pubblica-Sede di Medicina del Lavoro Servizio di Fisiopatologia Respiratoria

    Padova, 35127

  • Malattie dell'Apparato Respiratorio - Università degli Studi di Pisa Ospedale Cisanello

    Pisa, 56100

Other trials in Italy

Russia5 sites

  • City Clinical Hospital № 61, Pulmonology Department

    Moscow, 119048

  • Central Clinical Hospital №1 OAO"RZD",Pulmonology Department

    Moscow, 125315

  • Clinical Hospital № 2, Pulmonology Department

    Yaroslavl, 150010

  • Clinical Hospital № 8, Pulmonology Department

    Yaroslavl, 150030

  • Regional Clinical Hospital, Department of Therapeutics of Post Graduate, Yaroslavl Medical Academy

    Yaroslavl, 150062

Other trials in Russia

Spain1 site

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

Other trials in Spain

About this study

Official title: 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

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).

Read the 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.

Being tested
salbutamol 100 mcg, BDP/salbutamol HFA pMDI, BDP/salbutamol CFC pMDI
Keywords
beclomethasone, as needed, salbutamol, wheezing
Medical subject headings
Asthma, Respiratory Sounds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • salbutamol 100 mcgDrug

    Also called Ventolin®

    To be used as needed for symptom relief

  • BDP/salbutamol HFA pMDIDrug

    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

  • BDP/salbutamol CFC pMDIDrug

    Also called Clenil® Compositum 250

    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

Study groups in NCT00528723
Study groupRoleWhat they receive
AExperimentalBDP/salbutamol HFA pMDI
Receives: Drug: salbutamol 100 mcg; Drug: BDP/salbutamol HFA pMDI
BActive comparatorBDP/salbutamol CFC pMDI
Receives: Drug: salbutamol 100 mcg; Drug: BDP/salbutamol CFC pMDI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean value of morning PEF (daily measured by the patient)

    Measured: last 2 weeks treatment

Secondary outcomes (8)

  1. Morning PEF daily measured by the patient at any other time point

    Measured: last 2 weeks treatment

  2. Evening PEF, and morning and evening FEV1 daily measured by the patient

    Measured: all treatment period (12 weeks), at each two weeks

  3. Pulmonary function parameters (FEV1, FVC, PEF and FEF25-75%)

    Measured: clinic visits

  4. 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);

    Measured: baseline (visit 2) and end of treatment (visit 6)

  5. Rates of asthma exacerbations (in total and by severity)

    Measured: all treatment period, at each two weeks

  6. Time to first asthma exacerbation

    Measured: all treatment period, at each two weeks

  7. Night-time and daytime use of relief salbutamol, and number of days (both day and night) without intake of salbutamol

    Measured: all treatment period, at each two weeks

  8. Nighttime and daytime symptoms scores, and number of symptoms-free days (both day and night)

    Measured: all treatment period, at each two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJan 2009
  4. Study completionJan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00528723
Sponsor's protocol ID
MC/PR/033004/002/06
Other IDs
2007-002816-25
Status last verified
Mar 2017
First submitted
11 Sep 2007
Last updated
30 Mar 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing salbutamol 100 mcg, BDP/salbutamol HFA pMDI and BDP/salbutamol CFC pMDI in people with Bronchial Asthma, run by Chiesi Farmaceutici S.p.A. at 25 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Ukraine, Italy, Russia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean value of morning PEF (daily measured by the patient) (time frame: last 2 weeks treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00528723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.

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