AsthmaPhase 2NCT00394914
Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure (Study P04295)
A Phase 2 study testing Pleconaril in people with Asthma and Common Cold, run by Merck Sharp & Dohme LLC.
Trial summary
This is a randomized, multi-center, double-blind, placebo-controlled study evaluating the efficacy of pleconaril nasal spray in preventing asthma exacerbation and common cold symptoms in asthmatic participants exposed to picornavirus respiratory infections. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Asthma, Common Cold, Picornavirus Infection
- What is being tested?
- Pleconaril
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 311 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Apr 2007
- Phase
- Phase 2
- 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 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be ≥6 to ≤65 years of age, of either sex, and of any race, with a diagnosis of asthma at least 2 years prior to the Screening Visit.
- Must have a history of two or more upper respiratory infection-induced asthma exacerbations in the past 24 months.
- For participants 6 to 17 years of age, exacerbations for the purpose of the inclusion criteria, will be defined as:
- An increase of four or more puffs of a short-acting beta-agonist (SABA) per day for at least 3 consecutive days, or
- An increase of two or more nebulizations of a SABA per day for at least 3 consecutive days, or
- Documentation of morning (AM) peak flow drops >20% per day for at least 2 consecutive days, or
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- Documentation of AM peak flow drops of ≥50% for at least 1 day.
- Must have been on a stable dose of any asthma medication (including immunotherapy) for at least 1 month prior to the Screening Visit.
- Must have a pre-bronchodilator FEV1 ≥50% predicted at the Screening Visit, when all prohibited medications have been withheld for the specified interval.
- If a reversibility test has not been performed within the previous 24 months, a participant, ≥17 years of age, must demonstrate an increase in absolute FEV1 of ≥12%, with an absolute volume increase of at least 200 mL. A participant <17 years of age, must demonstrate an increase in absolute FEV1 ≥12%.
- Must cohabit with at least one other person (family member, roommate).
- A participant (or the participant's legal representation) must be willing to give written informed consent and be able to adhere to dose and visit schedules.
- Must be free of any clinically significant disease, other than asthma, which would interfere with study evaluation.
- Must be in general good health, as confirmed by routine clinical and laboratory testing. All laboratory tests (Complete Blood Count, blood chemistries, and urinalysis) and elctrocardiograms must be within normal limits or clinically acceptable to the investigator/sponsor.
- Female of childbearing potential must be using a medically acceptable, adequate form of birth control.
Who cannot join
- Had an upper or lower respiratory illness or exhibits signs and/or symptoms of a respiratory illness in the 4 weeks prior to the Screening Visit.
- Received any treatment more recently than the indicated washout period prior to Screening or who must continue to receive treatment that is prohibited.
- Smoker or ex-smoker and has smoked within the previous 5 years of Screening or has had a cumulative smoking history >10 pack years.
- Allergy/sensitivity to the study drug or its excipients.
- Female who is breast-feeding, pregnant, or intends to become pregnant.
- Used any investigational drugs within 30 days of Screening.
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- Participating in any other clinical study.
- Part of the staff personnel directly involved with this study.
- Family member of the investigational study staff.
About this study
Official title: A Placebo-Controlled Study of the Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure
This is a randomized, multi-center, double-blind, placebo-controlled study evaluating the efficacy of pleconaril nasal spray in preventing asthma exacerbation and common cold symptoms in asthmatic participants exposed to picornavirus respiratory infections. Participants will be assigned treatment with pleconaril or placebo nasal spray for 7 days (14 doses). Participants will be followed for an additional 14 days.
- Conditions
- Asthma, Common Cold, Picornavirus Infection, Rhinovirus
- Being tested
- Pleconaril, Placebo to Pleconaril
- Medical subject headings
- Asthma, Common Cold, Picornaviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PleconarilDrug
Also called SCH 900819
Pleconaril nasal suspension is supplied in a bottle containing 120 actuations. Each actuation contains 1.5 mg of pleconaril.
Placebo to PleconarilDrug
Placebo nasal suspension
| Study group | Role | What they receive |
|---|---|---|
| Pleconaril | Experimental | Participants will receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses. Receives: Drug: Pleconaril |
| Placebo | Placebo comparator | Participants will receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses. Receives: Drug: Placebo to Pleconaril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Rhinovirus PCR-Positive Colds
The common cold was defined as moderate or severe rhinorrhea and at least one other cold symptom of moderate to severe intensity for at least 1 day, together with rhinovirus-positive polymerase chain reaction (PCR), after a participant had temporal exposure to an index case. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.
Measured: From time of exposure to index case to end of Follow-up Period (21 days)
Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR
Asthma exacerbation was defined as a participant having one of the following:
- 0.5 point or more increase in the Asthma Control Questionnaire (ACQ) from Baseline at Day 7. The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ.
- Any change to asthma treatment as prescribed by a physician, unscheduled contact (either office visit or phone contact where medication was changed for asthma symptoms), emergency room visit, or hospitalization.
PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.
Measured: From time of exposure to index case to end of Follow-up Period (21 days)
Secondary outcomes (8)
LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)
The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. Pooled standard deviations (SDs) and least square (LS) means were calculated based on an analysis of variates (ANOVA) model.
Measured: Baseline through the Final Visit (Day 21)
LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Pooled SDs and LS means were calculated based on an ANOVA model.
Measured: Baseline through the Final Visit (Day 21)
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model.
Measured: Baseline through the Final Visit (Day 21)
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model.
Measured: Baseline through the Final Visit (Day 21)
LS Mean Change From Baseline in Total Cold Symptom Score
Participants entered their cold symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total cold symptom score was the sum of 6 scores for rhinorrhea, nasal congestion, cough, score throat, malaise, and myalgia. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 18, with increasing scores reflecting more severe colds. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model.
Measured: Baseline through the Final Visit (Day 21)
LS Mean Change From Baseline in Total Asthma Symptom Score
Participants entered their asthma symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total asthma symptom score was the sum of 3 scores for wheeze, cough, and dyspnea. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 9, with increasing scores reflecting more severe asthma. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model.
Measured: Baseline through the Final Visit (Day 21)
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
SABAs such as albuterol were permitted during the study as rescue medication and required a 6-hour washout prior to each visit. Participants entered their asthma medication use into an e-diary twice daily beginning at the Screening Visit through completion of the study. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model.
Measured: Baseline through the Final Visit (Day 21)
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Participants entered their asthma-related changes in sleep into an e-diary once daily (in the morning) beginning at the Screening Visit through completion of the study. Changes from Baseline in asthma-related sleep interference were determined using the following question: How did cold and asthma symptoms interfere with your sleep? The question was scored as follows: 0 = None, no interference with sleep at all, 1 = Mild, not annoying or troublesome, adequate amount of sleep, 2 = Moderate, interfered somewhat with sleep, woke up a few times, average sleep, 3 = Severe, substantially interfered with sleep, poor sleep. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model.
Measured: Baseline through the Final Visit (Day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startAug 2006
- Primary completionApr 2007
- Study completionApr 2007
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.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394914
- Sponsor's protocol ID
- P04295
- Other IDs
- Doc ID: 3303796
- Status last verified
- Jun 2015
- First submitted
- 31 Oct 2006
- Last updated
- 16 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled Study of the Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure
- ClinicalTrials.gov ID
- NCT00394914
- Acronym / sponsor ID
- P04295
- Conditions
- Asthma, Common Cold, Picornavirus Infection, Rhinovirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 2 Nov 2006 (estimated)
- Results
- Posted 31 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, multi-center, double-blind, placebo-controlled study evaluating the efficacy of pleconaril nasal spray in preventing asthma exacerbation and common cold symptoms in asthmatic participants exposed to picornavirus respiratory infections. Participants will be assigned treatment with pleconaril or placebo nasal spray for 7 days (14 doses). Participants will be followed for an additional 14 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pleconaril | Experimental | Drug: PleconarilParticipants will receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses. |
| Placebo | Placebo comparator | Drug: Placebo to PleconarilParticipants will receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses. |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Must be ≥6 to ≤65 years of age, of either sex, and of any race, with a diagnosis of asthma at least 2 years prior to the Screening Visit.
- Must have a history of two or more upper respiratory infection-induced asthma exacerbations in the past 24 months.
- Must have been on a stable dose of any asthma medication (including immunotherapy) for at least 1 month prior to the Screening Visit.
- Must have a pre-bronchodilator FEV1 ≥50% predicted at the Screening Visit, when all prohibited medications have been withheld for the specified interval.
- If a reversibility test has not been performed within the previous 24 months, a participant, ≥17 years of age, must demonstrate an increase in absolute FEV1 of ≥12%, with an absolute volume increase of at least 200 mL. A participant <17 years of age, must demonstrate an increase in absolute FEV1 ≥12%.
Key exclusion criteria (9 listed)
- Had an upper or lower respiratory illness or exhibits signs and/or symptoms of a respiratory illness in the 4 weeks prior to the Screening Visit.
- Received any treatment more recently than the indicated washout period prior to Screening or who must continue to receive treatment that is prohibited.
- Smoker or ex-smoker and has smoked within the previous 5 years of Screening or has had a cumulative smoking history >10 pack years.
- Allergy/sensitivity to the study drug or its excipients.
- Female who is breast-feeding, pregnant, or intends to become pregnant.
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 |
|---|---|---|
| PleconarilAlso: SCH 900819Pleconaril nasal suspension is supplied in a bottle containing 120 actuations. Each actuation contains 1.5 mg of pleconaril. | Drug | Pleconaril |
| Placebo to PleconarilPlacebo nasal suspension | Drug | Placebo |
Primary outcome
Percentage of Participants With Rhinovirus PCR-Positive Colds
Time frame: From time of exposure to index case to end of Follow-up Period (21 days)
The common cold was defined as moderate or severe rhinorrhea and at least one other cold symptom of moderate to severe intensity for at least 1 day, together with rhinovirus-positive polymerase chain reaction (PCR), after a participant had temporal exposure to an index case. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.
Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR
Time frame: From time of exposure to index case to end of Follow-up Period (21 days)
Asthma exacerbation was defined as a participant having one of the following: 1. 0.5 point or more increase in the Asthma Control Questionnaire (ACQ) from Baseline at Day 7. The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. 2. Any change to asthma treatment as prescribed by a physician, unscheduled contact (either office visit or phone contact where medication was changed for asthma symptoms), emergency room visit, or hospitalization. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.
8 secondary outcomes
LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)
Time frame: Baseline through the Final Visit (Day 21)
LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline through the Final Visit (Day 21)
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
Time frame: Baseline through the Final Visit (Day 21)
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
Time frame: Baseline through the Final Visit (Day 21)
LS Mean Change From Baseline in Total Cold Symptom Score
Time frame: Baseline through the Final Visit (Day 21)
LS Mean Change From Baseline in Total Asthma Symptom Score
Time frame: Baseline through the Final Visit (Day 21)
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
Time frame: Baseline through the Final Visit (Day 21)
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Time frame: Baseline through the Final Visit (Day 21)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 2 study testing Pleconaril in people with Asthma and Common Cold, run by Merck Sharp & Dohme LLC.
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 15 inclusion and 9 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 16 Jul 2015. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 31 Oct 2013). 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?
Percentage of Participants With Rhinovirus PCR-Positive Colds (time frame: From time of exposure to index case to end of Follow-up Period (21 days)). The study lists 2 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 16 Jul 2015.