WheezePhase 4CONjuGATENCT02319564
Combined Glucocorticoid Adrenergic Therapy For Wheezy Preschool Children
A Phase 4 study testing Beclomethasone, Beclomethasone and Salbutamol and Aerochamber Max® in people with Wheeze, run by University of Calgary at 1 site in Canada.
Trial summary
The investigators goal is to conduct a pilot randomized controlled trial (RCT) whose purpose is to determine the feasibility of a randomized trial designed to determine if either inhaled beclomethasone or a combination of inhaled beclomethasone/salbutamol (Clenil Compositum) are superior to placebo in treating… Read more about this study
- Who is it for?
- Ages 12 to 60 months
- Conditions the study is for
- Wheeze
- What is being tested?
- Beclomethasone, Beclomethasone and Salbutamol and Aerochamber Max®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Oct 2016
- 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 12 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children 12-60 months of age
- wheeze on auscultation
- mild respiratory distress as measured by a score of < 3 on the Pediatric Respiratory Assessment Measure (PRAM)
- discharged home after evaluation by their ED physician.
Who cannot join
- treatment with oral or parenteral corticosteroids in the last 14 days
- treatment with more than 2 doses of inhaled corticosteroids in the previous seven days
- presence of a severe co-morbidity such as bronchopulmonary dysplasia, cystic fibrosis, congenital heart disease, adrenal disorder or immune deficiency
- previously enrolled into this study or concurrently enrolled in another intervention trial
- lack of telephone access or presence of a significant language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Assessing the Effectiveness of Beclomethasone and Combination Beclomethasone and Salbutamol as Compared With Placebo in Preschool Aged Children With Wheeze
The investigators goal is to conduct a pilot randomized controlled trial (RCT) whose purpose is to determine the feasibility of a randomized trial designed to determine if either inhaled beclomethasone or a combination of inhaled beclomethasone/salbutamol (Clenil Compositum) are superior to placebo in treating pre-school aged children with an acute wheezing episode.
- Conditions
- Wheeze
- Being tested
- Beclomethasone, Beclomethasone and Salbutamol, Placebo, Aerochamber Max®
- Keywords
- Wheeze, Asthma, Randomized Trial, Pre-school aged children
- Medical subject headings
- Respiratory Sounds, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeclomethasoneDrug
Also called Clenil
Beclomethasone and SalbutamolDrug
Also called Clenil Compositum
PlaceboDrug
Aerochamber Max®Device
Also called Masked Spacer for metered dose inhaler
| Study group | Role | What they receive |
|---|---|---|
| beclomethasone | Active comparator | beclomethasone dipropionate 250mcg per puff per puff (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days.
Non-identifiable MDI prepared by Chiesi Farmaceutici Inc. Receives: Drug: Beclomethasone; Device: Aerochamber Max® |
| beclomethasone and salbutamol | Active comparator | beclomethasone diprionate 250mcg and salbutamol 100mcg per puff (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days.
Non-identifiable MDI prepared by Chiesi Farmaceutici Inc. Receives: Drug: Beclomethasone and Salbutamol; Device: Aerochamber Max® |
| Placebo | Placebo comparator | placebo (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days.
Non-identifiable MDI prepared by Chiesi Farmaceutici Inc. Receives: Drug: Placebo; Device: Aerochamber Max® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce unplanned-symptomatic visits to clinicians
Measured: After enrolment is complete
Secondary outcomes (4)
Reduce the number of days with respiratory symptoms
Measured: Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days
Reduce the need for rescue salbutamol use
Measured: Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days
Reduce hospitalization rates of target population
Measured: Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days
Reduce overall societal health care costs of target population
Measured: Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Study population too narrow - unable to recruit any patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WheezeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Eastern Ontario
- Responsible party
- Principal investigator, David W Johnson, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319564
- Sponsor's protocol ID
- ConRCT1
- Acronym
- CONjuGATE
- Status last verified
- Nov 2016
- First submitted
- 30 Nov 2014
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Assessing the Effectiveness of Beclomethasone and Combination Beclomethasone and Salbutamol as Compared With Placebo in Preschool Aged Children With Wheeze
- ClinicalTrials.gov ID
- NCT02319564
- Acronym / sponsor ID
- CONjuGATE / ConRCT1
- Conditions
- Wheeze
- Keywords
- Wheeze, Asthma, Randomized Trial, Pre-school aged children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study population too narrow - unable to recruit any patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Children's Hospital of Eastern Ontario
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 Dec 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.
The investigators goal is to conduct a pilot randomized controlled trial (RCT) whose purpose is to determine the feasibility of a randomized trial designed to determine if either inhaled beclomethasone or a combination of inhaled beclomethasone/salbutamol (Clenil Compositum) are superior to placebo in treating pre-school aged children with an acute wheezing episode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| beclomethasone | Active comparator | Drug: Beclomethasone, Device: Aerochamber Max®beclomethasone dipropionate 250mcg per puff per puff (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days. Non-identifiable MDI prepared by Chiesi Farmaceutici Inc. |
| beclomethasone and salbutamol | Active comparator | Drug: Beclomethasone and Salbutamol, Device: Aerochamber Max®beclomethasone diprionate 250mcg and salbutamol 100mcg per puff (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days. Non-identifiable MDI prepared by Chiesi Farmaceutici Inc. |
| Placebo | Placebo comparator | Drug: Placebo, Device: Aerochamber Max®placebo (Chiesi metered dose inhaler) via a masked spacer (Aerochamber Max®, Plattsburgh, NY, USA). One puff BID for 14 days. Non-identifiable MDI prepared by Chiesi Farmaceutici Inc. |
Who may qualify
- Ages
- 12 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children 12-60 months of age
- wheeze on auscultation
- mild respiratory distress as measured by a score of < 3 on the Pediatric Respiratory Assessment Measure (PRAM)
- discharged home after evaluation by their ED physician.
Key exclusion criteria (5 listed)
- treatment with oral or parenteral corticosteroids in the last 14 days
- treatment with more than 2 doses of inhaled corticosteroids in the previous seven days
- presence of a severe co-morbidity such as bronchopulmonary dysplasia, cystic fibrosis, congenital heart disease, adrenal disorder or immune deficiency
- previously enrolled into this study or concurrently enrolled in another intervention trial
- lack of telephone access or presence of a significant language barrier
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 |
|---|---|---|
| BeclomethasoneAlso: Clenil | Drug | beclomethasone |
| Beclomethasone and SalbutamolAlso: Clenil Compositum | Drug | beclomethasone and salbutamol |
| Placebo | Drug | Placebo |
| Aerochamber Max®Also: Masked Spacer for metered dose inhaler | Device | Placebo, beclomethasone, beclomethasone and salbutamol |
Primary outcome
Reduce unplanned-symptomatic visits to clinicians
Time frame: After enrolment is complete
4 secondary outcomes
Reduce the number of days with respiratory symptoms
Time frame: Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days
Reduce the need for rescue salbutamol use
Time frame: Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days
Reduce hospitalization rates of target population
Time frame: Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days
Reduce overall societal health care costs of target population
Time frame: Will be analyzed 1-2 months after enrolment is complete, looking at the full follow-up period of 21 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beclomethasone, Beclomethasone and Salbutamol and Aerochamber Max® in people with Wheeze, run by University of Calgary at 1 site in Canada.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. Some participants in this study may receive a placebo. 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 withdrawn before enrolling participants, so there are no results.
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?
Reduce unplanned-symptomatic visits to clinicians (time frame: After enrolment is complete). 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 15 Nov 2016.