Acute Respiratory InfectionsPhase 4NCT00377403
Treatment of Acute Sinusitis
A Phase 4 study testing Acetaminophen, Amoxicillin and Dextromethorphan hydrobromide with guaifenesin in people with Acute Respiratory Infections and Acute Rhinosinusitis, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Respiratory Infections, Acute Rhinosinusitis
- What is being tested?
- Acetaminophen, Amoxicillin and Dextromethorphan hydrobromide with guaifenesin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Aug 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must be male or female, and between the ages of 18 and 70 years old.
- The subject must have symptoms of acute bacterial rhinosinusitis.
- The subject must be attending a participating primary care practice in the community.
- The subject must have symptoms of acute bacterial rhinosinusitis self-assessed as moderate, severe, or very severe.
- The subject must have access to a phone.
Who cannot join
- The subject is less than 18 years old or more than 70 years old.
- The subject has very mild or mild symptom severity assessed by self report.
- The subject has an allergy to penicillin or amoxicillin.
- The subject has received antibiotic therapy within the past 4 weeks (including chronic treatment for acne and low dose prophylactic treatment).
- The subject has complications of sinusitis (facial edema, cellulitis, or orbital, meningeal or cerebral signs).
- The subject is thought to require intravenous antibiotics or hospital admission.
Show all 14Show fewer
- The subject is pregnant. (This will be assessed by self-report. A pregnancy test will not be required).
- The subject has a comorbidity that may impair their immune response (such as immunodeficiency disease, uncontrolled cancer, or chemotherapy or radiation treatment).
- The subject has cystic fibrosis.
- The subject has Type I diabetes or is taking insulin to treat diabetes.
- The subject had prior sinus surgery.
- The subject requires an antibiotic for a concurrent condition such as an ear infection.
- The subject is not able to complete the study protocol because of language barriers, lack of telephone access, or other issues.
- Any other condition that the provider feels may interfere with the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Randomized Clinical Trial to Evaluate Guidelines for Acute Rhinosinusitis (Phase IV Study)
This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus infections will participate in this study for 28 days. Volunteers will receive a 10-day course of either amoxicillin or placebo (substance containing no medication). In addition, all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10, and 28 following the start of treatment. The study will look at quality of life factors such as change in functional status (ability to perform daily activities) and symptoms, recurrence of the infection, satisfaction with care, and the direct costs of treatment.
Read the detailed description
The primary objective of this phase IV, randomized, placebo controlled clinical trial is to determine the incremental effect of amoxicillin treatment compared with symptomatic treatments on disease-related quality of life in adults with clinically diagnosed acute bacterial rhinosinusitis. The secondary objective is to determine the incremental effect of amoxicillin treatment compared with symptomatic treatments on functional status, symptoms, disease recurrence, satisfaction with treatment, and direct costs of treatment in adults with clinically diagnosed acute bacterial rhinosinusitis. The tertiary objective is to identify prognostic indicators for clinical improvement with antibiotic treatment in adults with clinically diagnosed acute bacterial rhinosinusitis. Two hundred adult subjects, 18 to 70 years old, who meet the recommended criteria for acute bacterial rhinosinusitis, will be enrolled from 8 practice sites. Subjects will be randomized to receive a 10-day course of either amoxicillin or placebo. In addition, all subjects will receive an analgesic, an oral decongestant, a nasal saline spray, and an antitussive agent. Subject outcomes will be assessed by telephone interview at 0, 3, 7, 10, and 28 days. The primary outcome is the disease-specific quality of life at Day 3 measured with the SNOT-16, a validated evaluative instrument. Secondary outcomes include change in functional status and symptoms, disease recurrence, satisfaction with care and the direct costs of treatment. Tertiary outcome measures include possible subject and disease-related factors that predict clinical improvement with antibiotic treatment at Day 3 for use in future studies to aid clinical decision-making.
- Conditions
- Acute Respiratory Infections, Acute Rhinosinusitis
- Being tested
- Acetaminophen, Amoxicillin, Dextromethorphan hydrobromide with guaifenesin, Guaifenesin, Pseudoephedrine Sustained Action
- Keywords
- rhinosinusitis, sinusitis, amoxicillin
- Medical subject headings
- Rhinosinusitis, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Tylenol
Symptomatic treatment:
Dose: 500mg every 4 to 6 hours for pain or fever
AmoxicillinDrug
Also called Amoxil
Intervention drug:
Dose: 500mg tid for 10 days
Dextromethorphan hydrobromide with guaifenesinDrug
Also called Robitussin
Symptomatic treatment:
Dose: 10mls every 4 to 6 hours for cough
GuaifenesinDrug
Also called Mucinex OTC
Symptomatic treatment:
Dose: 600mg every 12 hours to thin secretions
Pseudoephedrine Sustained ActionDrug
Also called Sudafed
Symptomatic treatment:
Dose: 120mg every 12 hours for nasal congestion
Saline spray (0.65%)Drug
Also called Ocean Nasal Spray
Symptomatic treatment:
Dose: 2 squeezes per nostril as needed for nasal congestion
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Amoxicillin 500mg three times a day (tid) for 10 days in addition to symptomatic treatments Receives: Drug: Acetaminophen; Drug: Amoxicillin; Drug: Dextromethorphan hydrobromide with guaifenesin; Drug: Guaifenesin; Drug: Pseudoephedrine Sustained Action; Drug: Saline spray (0.65%) |
| Symptomatic treatments only | Placebo comparator | Placebo for 10 days in addition to symptomatic treatments Receives: Drug: Acetaminophen; Drug: Dextromethorphan hydrobromide with guaifenesin; Drug: Guaifenesin; Drug: Pseudoephedrine Sustained Action; Drug: Saline spray (0.65%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3
The Sino-Nasal Outcomes Test (SNOT-16) assesses disease-specific quality of life for acute and chronic rhinosinusitis. This brief instrument assesses 16 sinus-related symptoms and was administered by phone. The respondent reported how much they were bothered by each item considering both its severity and frequency. Response options include no problem (0), mild or slight problem (1), moderate problem (2), severe problem (3). The SNOT-16 score is the mean score from all 16 items and ranges from 0 (minimal impact) to 3 (significant impact).
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionMay 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory InfectionsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Garbutt, MD, Washington University School of Medicine
- Investigators
- Jane Garbutt, MB, ChB, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377403
- Sponsor's protocol ID
- 05-0140
- Other IDs
- U01AI064655-01A1
- Status last verified
- Dec 2012
- First submitted
- 14 Sep 2006
- Last updated
- 28 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Garbutt JM, Banister C, Spitznagel E, Piccirillo JF. Amoxicillin for acute rhinosinusitis: a randomized controlled trial. JAMA. 2012 Feb 15;307(7):685-92. doi: 10.1001/jama.2012.138.
PubMed 22337680Garbutt J, Spitznagel E, Piccirillo J. Use of the modified SNOT-16 in primary care patients with clinically diagnosed acute rhinosinusitis. Arch Otolaryngol Head Neck Surg. 2011 Aug;137(8):792-7. doi: 10.1001/archoto.2011.120.
PubMed 21844413
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate Guidelines for Acute Rhinosinusitis (Phase IV Study)
- ClinicalTrials.gov ID
- NCT00377403
- Acronym / sponsor ID
- 05-0140
- Conditions
- Acute Respiratory Infections, Acute Rhinosinusitis
- Keywords
- rhinosinusitis, sinusitis, amoxicillin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Oct 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 18 Sep 2006 (estimated)
- Results
- Posted 29 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus infections will participate in this study for 28 days. Volunteers will receive a 10-day course of either amoxicillin or placebo (substance containing no medication). In addition, all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10, and 28 following the start of treatment. The study will look at quality of life factors such as change in functional status (ability to perform daily activities) and symptoms, recurrence of the infection, satisfaction with care, and the direct costs of treatment.
Detailed description
The primary objective of this phase IV, randomized, placebo controlled clinical trial is to determine the incremental effect of amoxicillin treatment compared with symptomatic treatments on disease-related quality of life in adults with clinically diagnosed acute bacterial rhinosinusitis. The secondary objective is to determine the incremental effect of amoxicillin treatment compared with symptomatic treatments on functional status, symptoms, disease recurrence, satisfaction with treatment, and direct costs of treatment in adults with clinically diagnosed acute bacterial rhinosinusitis. The tertiary objective is to identify prognostic indicators for clinical improvement with antibiotic treatment in adults with clinically diagnosed acute bacterial rhinosinusitis. Two hundred adult subjects, 18 to 70 years old, who meet the recommended criteria for acute bacterial rhinosinusitis, will be enrolled from 8 practice sites. Subjects will be randomized to receive a 10-day course of either amoxicillin or placebo. In addition, all subjects will receive an analgesic, an oral decongestant, a nasal saline spray, and an antitussive agent. Subject outcomes will be assessed by telephone interview at 0, 3, 7, 10, and 28 days. The primary outcome is the disease-specific quality of life at Day 3 measured with the SNOT-16, a validated evaluative instrument. Secondary outcomes include change in functional status and symptoms, disease recurrence, satisfaction with care and the direct costs of treatment. Tertiary outcome measures include possible subject and disease-related factors that predict clinical improvement with antibiotic treatment at Day 3 for use in future studies to aid clinical decision-making.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: Acetaminophen, Drug: Amoxicillin, Drug: Dextromethorphan hydrobromide with guaifenesin, Drug: Guaifenesin, Drug: Pseudoephedrine Sustained Action, Drug: Saline spray (0.65%)Amoxicillin 500mg three times a day (tid) for 10 days in addition to symptomatic treatments |
| Symptomatic treatments only | Placebo comparator | Drug: Acetaminophen, Drug: Dextromethorphan hydrobromide with guaifenesin, Drug: Guaifenesin, Drug: Pseudoephedrine Sustained Action, Drug: Saline spray (0.65%)Placebo for 10 days in addition to symptomatic treatments |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject must be male or female, and between the ages of 18 and 70 years old.
- The subject must have symptoms of acute bacterial rhinosinusitis.
- The subject must be attending a participating primary care practice in the community.
- The subject must have symptoms of acute bacterial rhinosinusitis self-assessed as moderate, severe, or very severe.
- The subject must have access to a phone.
Key exclusion criteria (14 listed)
- The subject is less than 18 years old or more than 70 years old.
- The subject has very mild or mild symptom severity assessed by self report.
- The subject has an allergy to penicillin or amoxicillin.
- The subject has received antibiotic therapy within the past 4 weeks (including chronic treatment for acne and low dose prophylactic treatment).
- The subject has complications of sinusitis (facial edema, cellulitis, or orbital, meningeal or cerebral signs).
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 |
|---|---|---|
| AcetaminophenAlso: TylenolSymptomatic treatment: Dose: 500mg every 4 to 6 hours for pain or fever | Drug | Intervention Arm, Symptomatic treatments only |
| AmoxicillinAlso: AmoxilIntervention drug: Dose: 500mg tid for 10 days | Drug | Intervention Arm |
| Dextromethorphan hydrobromide with guaifenesinAlso: RobitussinSymptomatic treatment: Dose: 10mls every 4 to 6 hours for cough | Drug | Intervention Arm, Symptomatic treatments only |
| GuaifenesinAlso: Mucinex OTCSymptomatic treatment: Dose: 600mg every 12 hours to thin secretions | Drug | Intervention Arm, Symptomatic treatments only |
| Pseudoephedrine Sustained ActionAlso: SudafedSymptomatic treatment: Dose: 120mg every 12 hours for nasal congestion | Drug | Intervention Arm, Symptomatic treatments only |
| Saline spray (0.65%)Also: Ocean Nasal SpraySymptomatic treatment: Dose: 2 squeezes per nostril as needed for nasal congestion | Drug | Intervention Arm, Symptomatic treatments only |
Primary outcome
SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3
Time frame: 4 days
The Sino-Nasal Outcomes Test (SNOT-16) assesses disease-specific quality of life for acute and chronic rhinosinusitis. This brief instrument assesses 16 sinus-related symptoms and was administered by phone. The respondent reported how much they were bothered by each item considering both its severity and frequency. Response options include no problem (0), mild or slight problem (1), moderate problem (2), severe problem (3). The SNOT-16 score is the mean score from all 16 items and ranges from 0 (minimal impact) to 3 (significant impact).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22337680Garbutt JM, Banister C, Spitznagel E, Piccirillo JF. Amoxicillin for acute rhinosinusitis: a randomized controlled trial. JAMA. 2012 Feb 15;307(7):685-92. doi: 10.1001/jama.2012.138.
- Derived from this study: PubMed 21844413Garbutt J, Spitznagel E, Piccirillo J. Use of the modified SNOT-16 in primary care patients with clinically diagnosed acute rhinosinusitis. Arch Otolaryngol Head Neck Surg. 2011 Aug;137(8):792-7. doi: 10.1001/archoto.2011.120.
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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.
Jane Garbutt, MB, ChB principal investigator
Washington University School of Medicine
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 Acetaminophen, Amoxicillin and Dextromethorphan hydrobromide with guaifenesin in people with Acute Respiratory Infections and Acute Rhinosinusitis, run by Washington University School of Medicine at 1 site in United States.
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 14 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 28 Dec 2012. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3 (time frame: 4 days). 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 NCT00377403, which also lists 2 linked publications.
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 28 Dec 2012.