Preventing viral exacerbation of chronic obstructive pulmonary disease in upper respiratory tract infection: the PREVENT study

Preventing viral exacerbation of chronic obstructive pulmonary disease in upper respiratory tract infection: a multinational, double-blinded, randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN45572998

Enrollment

400

Registered

2010-12-08

Start date

2011-01-01

Completion date

Unknown

Last updated

2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD) Respiratory Other chronic obstructive pulmonary disease

Interventions

Additionally to the low maintenance dose steroid/LABA therapy (budesonide 200 µg/formoterol 6 µg bid), patients will be randomised to the combination corticosteroid/long-acting ß2-agonists ('steroid/L

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged greater than or equal to 40 years 2. Smoking history greater than or equal to 10 pack-years and moderate to very severe stable COPD (Global Initiative for Chronic Obstructive Lung Disease [GOLD] II - IV without exacerbation for greater than or equal to 4 weeks) 3. History of severe exacerbation in previous year

Exclusion criteria

Exclusion criteria: 1. Patients with pulmonary conditions other than COPD as the main respiratory disease 2. Rapid lethal disease 3. Severe immunosuppression 4. Known allergy or intolerance to the study medication 5. Pregnancy

Design outcomes

Primary

Measure	Time frame
Number (%) of patients developing exacerbation within 21 days of URTI onset in the group receiving intensified combination therapy with inhaled steroids/LABA and placebo.	—

Secondary

Measure	Time frame
Viral polymerase chain reaction (PCR) positivity during upper respiratory tract infection (URTI), exacerbations and stable periods; positive sputum bacteriology and positive PCR for atypical pathogens during exacerbation and stable periods; symptoms scores and MMRC dyspnea scale; therapy-related side-effects; duration and cumulative dose of steroids and antibiotics; hospital admission for any cause. Endpoints will be assessed 10 days after upper respiratory tract symptoms onset, after 21 days, in case of exacerbation, and in the stable period of the disease (at 6, 12, and 18 months). In a second step, endpoints will be assessed in subgroups of patients according to the COPD severity.	—

Measure

Time frame

Viral polymerase chain reaction (PCR) positivity during upper respiratory tract infection (URTI), exacerbations and stable periods; positive sputum bacteriology and positive PCR for atypical pathogens during exacerbation and stable periods; symptoms scores and MMRC dyspnea scale; therapy-related side-effects; duration and cumulative dose of steroids and antibiotics; hospital admission for any cause. Endpoints will be assessed 10 days after upper respiratory tract symptoms onset, after 21 days, in case of exacerbation, and in the stable period of the disease (at 6, 12, and 18 months). In a second step, endpoints will be assessed in subgroups of patients according to the COPD severity.

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Countries

Belgium, Italy, Netherlands, Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026