AsthmaPhase 4NCT02235428
Study to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, in Acute Asthmatic Attacks in Young Children
A Phase 4 study testing Ipratropium bromide and Salbutamol in people with Asthma, run by Boehringer Ingelheim.
Trial summary
To determine whether addition of ipratropium bromide to salbutamol nebulisations produces significantly greater bronchodilation in young children presenting to an emergency department with an acute attack of asthma Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Asthma
- What is being tested?
- Ipratropium bromide and Salbutamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Sep 1998to Sep 1998
- Phase
- Phase 4
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boys or girls between 3 and 6 years old
- Presenting to emergency departments with an acute asthmatic attack
- Requiring nebulised bronchodilator therapy
- Rint increased by 200 % compared to theoretical Rint
- Signed, informed consent obtained from the child's parents/legal guardian in accordance with current national legislation and good clinical practice (GCP) defined by the International Conference on Harmonization (ICH)
Who cannot join
- Ipratropium bromide received within four hours before admission
- First acute asthmatic attack
- Hospital admission to intensive care with asthma within six months before inclusion
- Hospital admission for asthma during the month prior to inclusion
- Corticosteroid-dependent asthma (oral corticosteroid therapy) or recently stopped corticosteroid therapy
- Concomitant cardiac disease
Show all 16Show fewer
- Life threatening disease requiring immediate management; including: silent chest on auscultation, cyanosis, bradycardia less than 60 beats/min (bpm), confusion, coma
- Hypersensitivity to ipratropium bromide, salbutamol, or to any of their excipients
- Renal or hepatic insufficiency
- Poorly controlled diabetes
- Patients suffering from a disease considered to be severe by the investigator and which, in the opinion of the investigator, could interfere or invalidate the measurements performed in the trial
- Past history of lung surgery
- Major respiratory disease: pulmonary fibrosis, bronchiectasis, sarcoidosis, tuberculosis, respiratory disease due to AIDS, cystic fibrosis
- Patients unable to follow with protocol or correctly undergo the evaluations
- Patients who are taking part in another clinical trial during this trial or who have done so within the month before the trial
- Previous participation in this trial
About this study
Official title: Double-blind, Controlled Trial to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, for 120 Minutes, in Acute Asthmatic Attacks in Young Children
To determine whether addition of ipratropium bromide to salbutamol nebulisations produces significantly greater bronchodilation in young children presenting to an emergency department with an acute attack of asthma
- Conditions
- Asthma
- Being tested
- Ipratropium bromide, Placebo, Salbutamol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipratropium bromideDrug
PlaceboDrug
SalbutamolDrug
| Study group | Role | What they receive |
|---|---|---|
| Ipratropium bromide | Experimental | Not described Receives: Drug: Ipratropium bromide; Drug: Salbutamol |
| Salbutamol | Active comparator | Not described Receives: Drug: Placebo; Drug: Salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in pulmonary resistance (Rint) between T0 and T120
Measured: Baseline, 120 minutes after drug administration
Secondary outcomes (13)
Assessment of accessory muscle recruitment on a 4-point scale
Measured: Up to 120 minutes after drug administration
Assessment of wheezing on a 4-point scale
Measured: Up to 120 minutes after drug administration
Assessment of dyspnoea on a 4-point scale
Measured: Up to 120 minutes after drug administration
Changes in respiratory rate
Measured: Up to 120 minutes after drug administration
Changes in Oxygen Saturation (ambient air)
Measured: Up to 120 minutes after drug administration
Changes in measurement of pulmonary resistance
Measured: Up to 120 minutes after drug administration
Number of patients dropped out because of lack of efficacy
Measured: Up to 120 minutes after drug administration
Number of patients with adverse events
Measured: Up to 17 days after last drug administration
Number of patients dropped out because of adverse events
Measured: Up to 17 days after last drug administration
Number of patients with clinical significant findings in blood pressure
Measured: Up to 120 minutes after drug administration
Number of patients with clinical significant findings in heart rate
Measured: Up to 120 minutes after drug administration
Hospital Admission rate
Measured: 120 minutes after drug administration
Assessment of Patient Status by investigator on a 3-question list
Measured: 72 hours after drug admimistration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startSep 1998
- Primary completionSep 1998
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 3 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
- NCT02235428
- Sponsor's protocol ID
- 244.2413
- Status last verified
- Sep 2014
- First submitted
- 9 Sep 2014
- Last updated
- 10 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Controlled Trial to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, for 120 Minutes, in Acute Asthmatic Attacks in Young Children
- ClinicalTrials.gov ID
- NCT02235428
- Acronym / sponsor ID
- 244.2413
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 1998
- Primary completion
- Sep 1998 (actual)
- First posted
- 10 Sep 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 determine whether addition of ipratropium bromide to salbutamol nebulisations produces significantly greater bronchodilation in young children presenting to an emergency department with an acute attack of asthma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipratropium bromide | Experimental | Drug: Ipratropium bromide, Drug: Salbutamol |
| Salbutamol | Active comparator | Drug: Placebo, Drug: Salbutamol |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Boys or girls between 3 and 6 years old
- Presenting to emergency departments with an acute asthmatic attack
- Requiring nebulised bronchodilator therapy
- Rint increased by 200 % compared to theoretical Rint
- Signed, informed consent obtained from the child's parents/legal guardian in accordance with current national legislation and good clinical practice (GCP) defined by the International Conference on Harmonization (ICH)
Key exclusion criteria (16 listed)
- Ipratropium bromide received within four hours before admission
- First acute asthmatic attack
- Hospital admission to intensive care with asthma within six months before inclusion
- Hospital admission for asthma during the month prior to inclusion
- Corticosteroid-dependent asthma (oral corticosteroid therapy) or recently stopped corticosteroid therapy
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 |
|---|---|---|
| Ipratropium bromide | Drug | Ipratropium bromide |
| Placebo | Drug | Salbutamol |
| Salbutamol | Drug | Ipratropium bromide, Salbutamol |
Primary outcome
Changes from baseline in pulmonary resistance (Rint) between T0 and T120
Time frame: Baseline, 120 minutes after drug administration
13 secondary outcomes
Assessment of accessory muscle recruitment on a 4-point scale
Time frame: Up to 120 minutes after drug administration
Assessment of wheezing on a 4-point scale
Time frame: Up to 120 minutes after drug administration
Assessment of dyspnoea on a 4-point scale
Time frame: Up to 120 minutes after drug administration
Changes in respiratory rate
Time frame: Up to 120 minutes after drug administration
Changes in Oxygen Saturation (ambient air)
Time frame: Up to 120 minutes after drug administration
Changes in measurement of pulmonary resistance
Time frame: Up to 120 minutes after drug administration
Number of patients dropped out because of lack of efficacy
Time frame: Up to 120 minutes after drug administration
Number of patients with adverse events
Time frame: Up to 17 days after last drug administration
Number of patients dropped out because of adverse events
Time frame: Up to 17 days after last drug administration
Number of patients with clinical significant findings in blood pressure
Time frame: Up to 120 minutes after drug administration
Number of patients with clinical significant findings in heart rate
Time frame: Up to 120 minutes after drug administration
Hospital Admission rate
Time frame: 120 minutes after drug administration
Assessment of Patient Status by investigator on a 3-question list
Time frame: 72 hours after drug admimistration
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 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 4 study testing Ipratropium bromide and Salbutamol 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 5 inclusion and 16 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: stopped early, as of the sponsor's last update on 10 Sep 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early. Results are not available in the source record.
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?
Changes from baseline in pulmonary resistance (Rint) between T0 and T120 (time frame: Baseline, 120 minutes after drug administration). 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 10 Sep 2014.