ColdPhase 4NCT02238210
Safety Trial of Atrovent® in Pediatric Patients With Rhinorrhea Associated With a Common Cold or Allergy
A Phase 4 study testing Atrovent® in people with Cold, run by Boehringer Ingelheim.
Trial summary
Study to determine the safety of Atrovent Nasal Spray 0.06% in pediatric patients (ages 2-5 years) with symptoms of rhinorrhea associated with a naturally occurring common cold or from symptoms of rhinorrhea associated with allergies Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Cold
- What is being tested?
- Atrovent®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to May 2003
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female at least 2 but not older than 5 years of age at screening
- Have a diagnosis of a common cold defined as presence of acute onset of rhinorrhea (within 48 hours of screening visit) and at least 1 of the following:
- Presence of swollen nasal membranes characteristic of a common cold on examination at screening
- Presence of fever up to 102°F (oral or equivalent) within 48 hours of visit (may be taken at home/away from the clinic) or at time of screening
- Capability of parent/legal guardian to read and understand the informed consent, record trial diary information, administer trial drug and read and understand trial assessment questionnaire
- Male or female at least 2 but not older than 5 year of age
Show all 41Show fewer
- Have a diagnosis of seasonal or perennial allergic rhinitis defined as having both of the following:
- Positive skin or Radioallergosorbent test (RAST) test to a relevant allergen within 12 months of screening or at the screening visit. For the purpose of this trial a positive skin test is defined as wheal diameter that is at least 3 mm greater than the negative control
- Positive prior history for atopy with nasal symptoms associated with expose to allergens
- Symptoms associated with rhinorrhea for at least 48 hours prior to the screening visit
- Capability of parent/legal guardian to read and understand the informed consent, record trial diary information, administer trial drug and read and understand trial assessment questionnaire
- General Exclusion Criteria for both common cold and allergy
- Significant cardiovascular, renal, hepatic, endocrine, metabolic, neurologic or other systemic disease. A significant disease was defined as one which, in the opinion of the Investigator, either put the patient at risk because of participation in the trial or influenced the results of the trial or the patient's ability to participate in the trial
- Presence of rales or rhonchi suggestive of a lower respiratory tract infection
- An oral (or equivalent) temperature higher than 102°F
- Presence of otitis media
- Be initiating or advancing immunotherapy regimen during the course of this trial. Patients receiving a maintenance dose of immunotherapy are eligible
- Known intolerance to anticholinergics of hypersensitivity to benzalkonium chloride
- Excluded medications prior to Visit 1 and during the trial included:
- 24 hours before
- Over-the-counter decongestants or nasal/ocular cromolyn
- 3 days before:
- Anticholinergics
- Over-the-counter antihistamines
- sympathomimetic decongestants
- 5 days before:
- Fexofenadine
- Loratadine
- 7 days before:
- Cetirizine
- antihistamines such as Atarax® or doxepin hydrochloride
- Antidepressants
- 14 days before:
- Intranasal steroids
- 28 days before:
- Steroids (oral and injectable)
- Leukotriene modifiers (e.g. Accolate®, Singulair®)
- Other investigational drugs
- Participation in any trial with an investigational drug within 30 days of the screening visit
- Nasal obstruction greater than 50% that would prevent deposition of trial drug
- The parent/legal guardian has a disability or lives in a geographical location that could impair compliance with the protocol or visits to the trial center
Who cannot join
- History or perennial allergic rhinitis or seasonal allergic rhinitis (SAR) with allergen in season
- Positive Streptococcus test
- Patients with active infectious rhinitis (common cold) as determined by history and physical
- Patients with upper or lower respiratory infection at screening
About this study
Official title: A Phase IV Safety Trial in Pediatric Patients (Ages 2-5) With Rhinorrhea Associated With a Common Cold or Allergy
Study to determine the safety of Atrovent Nasal Spray 0.06% in pediatric patients (ages 2-5 years) with symptoms of rhinorrhea associated with a naturally occurring common cold or from symptoms of rhinorrhea associated with allergies
- Conditions
- Cold
- Being tested
- Atrovent®
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrovent®Drug
| Study group | Role | What they receive |
|---|---|---|
| Atrovent® - common cold group | Experimental | Treatment duration for common cold group - three time daily for 4 days Receives: Drug: Atrovent® |
| Experimental: Atrovent® - allergy group | Experimental | Treatment duration for allergy group - three time daily for 14 days Receives: Drug: Atrovent® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's parent/legal guardian global assessment - common cold group
Measured: Day 4
Number of patients with adverse events
Measured: up to 21 days
Patient's parent/legal guardian global assessment - allergy group
Measured: Day 14
Secondary outcomes (8)
Patient's parent/legal guardian daily assessment of rhinorrhea (runny nose) rated on 5-point scale - common cold group
daily assessment by e-diary
Measured: Day 4
Patient's parent/legal guardian daily assessment of nasal congestion (stuffy nose) rated on 5-point scale - common cold group
daily assessment by e-diary
Measured: Day 4
Patient's parent/legal guardian daily assessment of sneezing rated on 5-point scale - common cold group
daily assessment by e-diary
Measured: Day 4
Number of patients with clinically findings in nasal and otoscopic examination - common cold group
Measured: up to day 4
Patient's parent/legal guardian daily assessment of rhinorrhea (runny nose) rated on 5-point scale - allergy group
daily assessment by e-diary
Measured: Day 14
Patient's parent/legal guardian daily assessment of nasal congestion (stuffy nose) rated on 5-point scale - allergy group
daily assessment by e-diary
Measured: Day 14
Patient's parent/legal guardian daily assessment of sneezing rated on 5-point scale - allergy group
daily assessment by e-diary
Measured: Day 14
Number of patients with clinically findings in nasal and otoscopic examination - allergy group
Measured: up to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startDec 2002
- Primary completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColdStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 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
- NCT02238210
- Sponsor's protocol ID
- 244.2503
- Status last verified
- Sep 2014
- First submitted
- 11 Sep 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Safety Trial in Pediatric Patients (Ages 2-5) With Rhinorrhea Associated With a Common Cold or Allergy
- ClinicalTrials.gov ID
- NCT02238210
- Acronym / sponsor ID
- 244.2503
- Conditions
- Cold
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- May 2003 (actual)
- First posted
- 12 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.
Study to determine the safety of Atrovent Nasal Spray 0.06% in pediatric patients (ages 2-5 years) with symptoms of rhinorrhea associated with a naturally occurring common cold or from symptoms of rhinorrhea associated with allergies
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrovent® - common cold group | Experimental | Drug: Atrovent®Treatment duration for common cold group - three time daily for 4 days |
| Experimental: Atrovent® - allergy group | Experimental | Drug: Atrovent®Treatment duration for allergy group - three time daily for 14 days |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (41 listed)
- Male or female at least 2 but not older than 5 years of age at screening
- Have a diagnosis of a common cold defined as presence of acute onset of rhinorrhea (within 48 hours of screening visit) and at least 1 of the following:
- Capability of parent/legal guardian to read and understand the informed consent, record trial diary information, administer trial drug and read and understand trial assessment questionnaire
- Male or female at least 2 but not older than 5 year of age
- Have a diagnosis of seasonal or perennial allergic rhinitis defined as having both of the following:
Key exclusion criteria (4 listed)
- History or perennial allergic rhinitis or seasonal allergic rhinitis (SAR) with allergen in season
- Positive Streptococcus test
- Patients with active infectious rhinitis (common cold) as determined by history and physical
- Patients with upper or lower respiratory infection at screening
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 |
|---|---|---|
| Atrovent® | Drug | Atrovent® - common cold group, Experimental: Atrovent® - allergy group |
Primary outcome
Patient's parent/legal guardian global assessment - common cold group
Time frame: Day 4
Number of patients with adverse events
Time frame: up to 21 days
Patient's parent/legal guardian global assessment - allergy group
Time frame: Day 14
8 secondary outcomes
Patient's parent/legal guardian daily assessment of rhinorrhea (runny nose) rated on 5-point scale - common cold group
Time frame: Day 4
Patient's parent/legal guardian daily assessment of nasal congestion (stuffy nose) rated on 5-point scale - common cold group
Time frame: Day 4
Patient's parent/legal guardian daily assessment of sneezing rated on 5-point scale - common cold group
Time frame: Day 4
Number of patients with clinically findings in nasal and otoscopic examination - common cold group
Time frame: up to day 4
Patient's parent/legal guardian daily assessment of rhinorrhea (runny nose) rated on 5-point scale - allergy group
Time frame: Day 14
Patient's parent/legal guardian daily assessment of nasal congestion (stuffy nose) rated on 5-point scale - allergy group
Time frame: Day 14
Patient's parent/legal guardian daily assessment of sneezing rated on 5-point scale - allergy group
Time frame: Day 14
Number of patients with clinically findings in nasal and otoscopic examination - allergy group
Time frame: up to day 14
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 12 Sep 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atrovent® in people with Cold, 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 41 inclusion and 4 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 12 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 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?
Patient's parent/legal guardian global assessment - common cold group (time frame: Day 4). The study lists 3 primary outcomes in all. 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 12 Sep 2014.