AsthmaPhase 3NCT02181335
Efficacy and Safety Study Comparing Respimat ® Budesonide With Turbohaler ® Budesonide in Symptomatic Adult Moderate to Severe Asthmatics Requiring Inhaled Corticosteroids and Bronchodilator Therapy
A Phase 3 study testing Respimat® Budesonide low dose, Respimat® Budesonide high dose and Turbohaler® Budesonide in people with Asthma, run by Boehringer Ingelheim.
Trial summary
To establish that at least one of the two doses of Budesonide, as an ethanolic solution inhaled from the Respimat ® inhaler (100 and 200 mcg, 2 puffs bid) for a 12-week study period in symptomatic moderate to severe asthmatic patients, gives a therapeutic response, which is not inferior to that obtained from the dose… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Respimat® Budesonide low dose, Respimat® Budesonide high dose and Turbohaler® Budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 684 participants
- Where
- No sites listed yet
- Study dates
- Oct 1998to Jun 2001
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex aged 18 - 65 years (inclusive)
- Non-smokers or ex smokers. HAVING stopped smoking >= 1 year prior to screening and with a smoking history of <= 10 pack years
- Diagnosis of MODERATE to SEVERE bronchial asthma with a duration of at least 6 months with the inclusion criteria 4 plus 5 and a diagnosis of asthma according to the WHO guidelines for at least one year
- Increase of asthma symptoms (wheeze, cough, shortness of breath, chest tightness) when exposure to any of the following stimuli: cold, dry air, dust, smoke, exercise and allergens
- Patients on a stable dosage of either
- 800 mcg <= BDP (beclomethasone dipropionate) <= 1600 mcg daily or other inhaled steroid with or without inhaled long acting β2-agonists or oral xanthines at screening visit 1 for the past 4 weeks and short acting β2-agonists prn for the past 6 weeks or
Show all 13Show fewer
- 400 mcg <= BDP < 800 mcg daily or other inhaled steroid and inhaled long-acting β2-agonists (or oral xanthines), at screening visit 1 for the past 4 weeks and short acting β2-agonists prn for the past 6 weeks
- FEV1 >= 60% but <= 90 % predicted normal at visit 1 after withholding respiratory drugs as per section 4.2.1. Predicted normal values are based on the guidelines for standardized function testing of the European Community for Coal and Steel (ECCS)
- Males: FEV1 pred. (L) = 4.30 x Height (m) - 0.029 x Age (yrs) - 2.49
- Females: FEV1 pred. (L) = 3.95 x Height (m) - 0025 x Age (yrs) - 2.60
- Patient must demonstrate an improvement in FEV 1 >= 12% above baseline and an absolute change of at least 200 ml within 30 minutes after administration of two puffs of salbutamol MDI (metered dose inhaler) (100 mcg per puff). Historical data within the previous 6 months are acceptable
- Patients must be able to be trained in the proper use of MDI, Turbohaler® and Respimat® and to perform technically satisfactory pulmonary function tests
- Patients must be willing and be able to give informed written consent prior to participation in the trial i.e. prior to pre-study wash-out of their usual pulmonary medications and are willing and able to complete the entire study as described in the protocol
Who cannot join
- Patients with a history of seasonal exacerbation of asthma suggesting seasonal asthma which would not be controlled by medication allowed in the protocol (see 4.2.2) and likely to occur during the time period that the patients will be in the study
- History of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction if they are clinically significant. A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
- Patients with a recent history (<= 1 year) of myocardial infarction and/or (<= 3 years) of heart failure or patients with any cardiac arrhythmia requiring drug therapy
- History of cancer within the past 5 years excluding treated basal cell carcinoma
- Patients with current psychiatric disorders which would interfere with the conduct of the trial
- Patients with history or presence of glaucoma and/or posterior subcapsular cataracts
Show all 28Show fewer
- Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criteria
- Patients with active tuberculosis with indication for treatment
- Patients with a history of cystic fibrosis, bronchiectasis, chronic bronchitis or emphysema
- Patients with active rhinitis requiring treatment with intranasal steroids and/or ketotifen
- Patients with upper respiratory tract infection in the past 6 weeks prior to screening visit 1 resulting in exacerbation of asthma symptoms
- Patients with unstable asthma as defined by any of the following: having required hospitalization for asthma exacerbation in the past 6 months, or a history of life-threatening asthma exacerbation resulted in respiratory failure and requiring intubation or ICU admission of longer than 24 hours in the past 5 years
- Patients with clinically signification abnormal baseline haematology, blood chemistry or urinalysis (if the abnormality defines a disease listed as an exclusion criterion)
- Patients with any of the abnormal laboratory values below:
- SGOT (serum glutamate oxaloacetate transaminase) > 200% of the upper limit of the normal range
- SGPT (serum glutamate pyruvate transaminase) > 200% of the upper limit of the normal range
- Creatinine > 125% of the upper limit of the normal range
- Bilirubin > 150% of the upper limit of the normal range, with the exception of Gilbert's disease will be excluded regardless of the clinical condition
- Patients with known intolerance hypersensitivity to one of the aerosolized products including inhaled steroids (budesonide and beclomethasone dipropionate), salbutamol, ethylenediaminetetraacetic acid, ethanol, citric or oleic acid
- Patients using oral or other systemic (intramuscular or intravenous) corticosteroids in the past 8 weeks or other potent immunosuppressant (i.e. methotrexate) medication in the past 3 months
- Patients using beta blocker therapy, ACE inhibitors (an exception was provided if the ACE inhibitor have been at a stable dose for six months with no reported incidence of cough) monoamine oxidase inhibitors, tricyclic antidepressants, cromolyn or nedocromil sodium, ketotifen, astemizole or any other antihistamine drug, or a combination of an inhaled long acting β2-agonist plus oral xanthine or having received an influenza vaccine within 1 week of Screening Visit 1
- Patients on nebulised β2-agonists, anticholinergics or steroids in the 4 weeks before screening visit 1
- If a patient is on allergen desensitization therapy, this should have been as a maintenance dose for the previous 3 months and continued throughout the treatment period
- Unstable respiratory medication dosage in the last 4 weeks prior to screening visit 1
- Patients with a significant history and/or active alcohol or drug abuse. Significant is defined as that 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 patient's ability to participate in the study
- Patients who have taken any investigational drug, one month or six half-lives (whichever is greater) prior to the Screening Visit
- Pregnant or nursing women and sexually active women with childbearing potential not using a medically approved method of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm, Norplant® or double-barrier)
- Previous participation in the randomised period of this study
About this study
Official title: A Twelve-week, Efficacy and Safety Study Comparing Respimat ® Budesonide (100 and 200 mcg, 2 Puffs Bid) With Turbohaler ® Budesonide (200 mcg, 2 Puffs Bid) in Symptomatic Adult Moderate to Severe Asthmatic Requiring Inhaled Corticosteroids and Bronchodilator Therapy.
To establish that at least one of the two doses of Budesonide, as an ethanolic solution inhaled from the Respimat ® inhaler (100 and 200 mcg, 2 puffs bid) for a 12-week study period in symptomatic moderate to severe asthmatic patients, gives a therapeutic response, which is not inferior to that obtained from the dose of Budesonide inhaled from the Turbohaler ® (200 mcg, 2 puffs bid) and that the safety profile is at least as good
- Conditions
- Asthma
- Being tested
- Respimat® Budesonide low dose, Respimat® Budesonide high dose, Turbohaler® Budesonide, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respimat® Budesonide low doseDrug
Respimat® Budesonide high doseDrug
Turbohaler® BudesonideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Respimat ® Budesonide low dose + Turbohaler® Placebo | Experimental | Not described Receives: Drug: Respimat® Budesonide low dose; Drug: Placebo |
| Respimat ® Budesonide high dose + Turbohaler® Placebo | Experimental | Not described Receives: Drug: Respimat® Budesonide high dose; Drug: Placebo |
| Turbohaler® Budesonide + Respimat Placebo® | Active comparator | Not described Receives: Drug: Turbohaler® Budesonide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean weekly morning pre-dose Peak Expiratory Flow Rate (a.m. PEFR)
Measured: Day1, 15, 29, 43, 57, 71, 85 (before intake of inhaled medication)
Secondary outcomes (27)
Change in Forced Expiratory Volume in one second (FEV1)
Measured: Baseline, Day1, 15, 29, 43, 57, 71, 85
Change in Forced Vital Capacity (FVC)
Measured: Baseline, Day1, 15, 29, 43, 57, 71, 85
Change in Peak Expiratory Flow Rate (PEFR)
Measured: Baseline, Day1, 15, 29, 43, 57, 71, 85
Changes in Mean weekly evening pre-dose PEFR (p.m. PEFR)
Measured: Day1, 15, 29, 43, 57, 71, 85 (before intake of inhaled medication)
Daily puffs of β2-agonists usage
Measured: up to 85 days
Diurnal and nocturnal asthma symptom score
Measured: up to 85 days
Symptoms free days and/or nights
Measured: up to 85 days
Withdrawal due to moderate or severe asthma exacerbation
Measured: up to 85 days
Change in Forced expiratory flow at 25-75% of vital capacity (FEF 25-75%)
Measured: Baseline, Day1, 15, 29, 43, 57, 71, 85
Change in systolic blood pressure
Measured: Baseline, Day1, 15, 29, 43, 57, 71, 85
Change in pulse rate
Measured: Baseline, Day1, 15, 29, 43, 57, 71, 85
Change from baseline in 12-lead electrocardiogram (ECG)
Measured: Baseline, Day 85
Changes from baseline in laboratory parameters
Measured: Baseline, Day 85
Occurence of adverse events
Measured: up to 85 days
Incidence of administration related bronchoconstriction at first and last dose
Measured: Day 1, Day 85
Markers of bone formation - Plasma osteocalcin levels (sub-group of patients)
Measured: Day 1, Day 85
Markers of bone formation - Bone alkaline phosphatase (sub-group of patients)
Measured: Day 1, Day 85
Markers of bone formation - serum calcium (all study population)
Measured: Day 1, Day 85
Markers of bone formation - serum phosphate (all study population)
Measured: Day 1, Day 85
Markers of bone formation - serum procollagen I (sub-group of patients)
Measured: Day 1, Day 85
Markers of bone dissolution - Urine deoxypyridiline (subset of patients)
Measured: Day 1, Day 85
Serum cortisol levels (a.m.) - (subset of study population)
Measured: Day 1, 29, 57, 85
10 hour urinary free cortisol/creatinine ratio (subset of study population)
Measured: Day 1, 29, 57, 85
Oral Candidiasis (quantitative assessment)
Measured: up to 85 days
Incidence of hoarseness of voice
Measured: up to 85 days
Incidence of sore throat
Measured: up to 85 days
Markers of bone formation - Alkaline phosphatase (all study population)
Measured: Day1, Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startOct 1998
- Primary completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Enrolment
- 684 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181335
- Sponsor's protocol ID
- 1047.16
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twelve-week, Efficacy and Safety Study Comparing Respimat ® Budesonide (100 and 200 mcg, 2 Puffs Bid) With Turbohaler ® Budesonide (200 mcg, 2 Puffs Bid) in Symptomatic Adult Moderate to Severe Asthmatic Requiring Inhaled Corticosteroids and Bronchodilator Therapy.
- ClinicalTrials.gov ID
- NCT02181335
- Acronym / sponsor ID
- 1047.16
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 1998
- Primary completion
- Jun 2001 (actual)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish that at least one of the two doses of Budesonide, as an ethanolic solution inhaled from the Respimat ® inhaler (100 and 200 mcg, 2 puffs bid) for a 12-week study period in symptomatic moderate to severe asthmatic patients, gives a therapeutic response, which is not inferior to that obtained from the dose of Budesonide inhaled from the Turbohaler ® (200 mcg, 2 puffs bid) and that the safety profile is at least as good
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Respimat ® Budesonide low dose + Turbohaler® Placebo | Experimental | Drug: Respimat® Budesonide low dose, Drug: Placebo |
| Respimat ® Budesonide high dose + Turbohaler® Placebo | Experimental | Drug: Respimat® Budesonide high dose, Drug: Placebo |
| Turbohaler® Budesonide + Respimat Placebo® | Active comparator | Drug: Turbohaler® Budesonide, Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients of either sex aged 18 - 65 years (inclusive)
- Non-smokers or ex smokers. HAVING stopped smoking >= 1 year prior to screening and with a smoking history of <= 10 pack years
- Diagnosis of MODERATE to SEVERE bronchial asthma with a duration of at least 6 months with the inclusion criteria 4 plus 5 and a diagnosis of asthma according to the WHO guidelines for at least one year
- Increase of asthma symptoms (wheeze, cough, shortness of breath, chest tightness) when exposure to any of the following stimuli: cold, dry air, dust, smoke, exercise and allergens
- Patients on a stable dosage of either
Key exclusion criteria (28 listed)
- Patients with a history of seasonal exacerbation of asthma suggesting seasonal asthma which would not be controlled by medication allowed in the protocol (see 4.2.2) and likely to occur during the time period that the patients will be in the study
- History of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction if they are clinically significant. A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
- Patients with a recent history (<= 1 year) of myocardial infarction and/or (<= 3 years) of heart failure or patients with any cardiac arrhythmia requiring drug therapy
- History of cancer within the past 5 years excluding treated basal cell carcinoma
- Patients with current psychiatric disorders which would interfere with the conduct of the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respimat® Budesonide low dose | Drug | Respimat ® Budesonide low dose + Turbohaler® Placebo |
| Respimat® Budesonide high dose | Drug | Respimat ® Budesonide high dose + Turbohaler® Placebo |
| Turbohaler® Budesonide | Drug | Turbohaler® Budesonide + Respimat Placebo® |
| Placebo | Drug | Respimat ® Budesonide high dose + Turbohaler® Placebo, Respimat ® Budesonide low dose + Turbohaler® Placebo, Turbohaler® Budesonide + Respimat Placebo® |
Primary outcome
Change in mean weekly morning pre-dose Peak Expiratory Flow Rate (a.m. PEFR)
Time frame: Day1, 15, 29, 43, 57, 71, 85 (before intake of inhaled medication)
27 secondary outcomes
Change in Forced Expiratory Volume in one second (FEV1)
Time frame: Baseline, Day1, 15, 29, 43, 57, 71, 85
Change in Forced Vital Capacity (FVC)
Time frame: Baseline, Day1, 15, 29, 43, 57, 71, 85
Change in Peak Expiratory Flow Rate (PEFR)
Time frame: Baseline, Day1, 15, 29, 43, 57, 71, 85
Changes in Mean weekly evening pre-dose PEFR (p.m. PEFR)
Time frame: Day1, 15, 29, 43, 57, 71, 85 (before intake of inhaled medication)
Daily puffs of β2-agonists usage
Time frame: up to 85 days
Diurnal and nocturnal asthma symptom score
Time frame: up to 85 days
Symptoms free days and/or nights
Time frame: up to 85 days
Withdrawal due to moderate or severe asthma exacerbation
Time frame: up to 85 days
Change in Forced expiratory flow at 25-75% of vital capacity (FEF 25-75%)
Time frame: Baseline, Day1, 15, 29, 43, 57, 71, 85
Change in systolic blood pressure
Time frame: Baseline, Day1, 15, 29, 43, 57, 71, 85
Change in pulse rate
Time frame: Baseline, Day1, 15, 29, 43, 57, 71, 85
Change from baseline in 12-lead electrocardiogram (ECG)
Time frame: Baseline, Day 85
Changes from baseline in laboratory parameters
Time frame: Baseline, Day 85
Occurence of adverse events
Time frame: up to 85 days
Incidence of administration related bronchoconstriction at first and last dose
Time frame: Day 1, Day 85
Markers of bone formation - Plasma osteocalcin levels (sub-group of patients)
Time frame: Day 1, Day 85
Markers of bone formation - Bone alkaline phosphatase (sub-group of patients)
Time frame: Day 1, Day 85
Markers of bone formation - serum calcium (all study population)
Time frame: Day 1, Day 85
Markers of bone formation - serum phosphate (all study population)
Time frame: Day 1, Day 85
Markers of bone formation - serum procollagen I (sub-group of patients)
Time frame: Day 1, Day 85
Markers of bone dissolution - Urine deoxypyridiline (subset of patients)
Time frame: Day 1, Day 85
Serum cortisol levels (a.m.) - (subset of study population)
Time frame: Day 1, 29, 57, 85
10 hour urinary free cortisol/creatinine ratio (subset of study population)
Time frame: Day 1, 29, 57, 85
Oral Candidiasis (quantitative assessment)
Time frame: up to 85 days
Incidence of hoarseness of voice
Time frame: up to 85 days
Incidence of sore throat
Time frame: up to 85 days
Markers of bone formation - Alkaline phosphatase (all study population)
Time frame: Day1, Day 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Respimat® Budesonide low dose, Respimat® Budesonide high dose and Turbohaler® Budesonide in people with Asthma, run by Boehringer Ingelheim.
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 13 inclusion and 28 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 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in mean weekly morning pre-dose Peak Expiratory Flow Rate (a.m. PEFR) (time frame: Day1, 15, 29, 43, 57, 71, 85 (before intake of inhaled medication)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2014.