CompletedPhase 3

A Study in Patients With Chronic Obstructive Pulmonary Disease

Denmark, France, Germany419 participantsStarted 2011-04-12

Plain-language summary

The primary objective of the study was to demonstrate the superiority of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.), in terms of pulmonary function (AUC0-30min standardized by time of change from pre-dose in FEV1) after drug inhalation in the morning of day 1, and the equivalence between Foster® 100/6 (two puffs b.i.d.) and Seretide® 500/50 (one inhalation b.i.d.) in terms of Transition Dyspnoea Index (TDI) score at day 84 in patients with COPD. The secondary objectives of the study were: * To evaluate the efficacy of the test treatments in terms of additional spirometric parameters and of clinical outcome measures; * To assess the safety and tolerability; * To perform an exploratory analysis evaluating the consumption of resources deriving from COPD management in the perspective of the Healthcare System.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female patients aged ≥ 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or once applicable written informed consent obtained by legal representative.
. Outpatients with a diagnosis of COPD and including:
. Smoking history of at least 10 pack years defined as \[(number of cigarettes smoked per day) x (number of years of smoking) / 20\], both current and ex-smokers are eligible.
. Use of bronchodilators in the previous 2 months to visit 1.
. Post-bronchodilator FEV1 \< 60% of the predicted normal value.
. Post-bronchodilator FEV1/FVC \< 0.7.
. A ≥ 5% response to a reversibility test.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under the Curve (AUC) 0-30min Standardized by Time of Change From Pre-dose in Forced Expiratory Volume in One Second (FEV1) in the Morning of Day 1

Timeframe: on Day 1 (V2)

Transition Dyspnoea Index (TDI) Score at Day 84

Timeframe: Day 84 (V5)

Trial details

NCT IDNCT01245569

SponsorChiesi Farmaceutici S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-03-13

Results submitted2026-01-20

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease trials

Plain-language summary

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female patients aged ≥ 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or once applicable written informed consent obtained by legal representative.
. Outpatients with a diagnosis of COPD and including:
. Smoking history of at least 10 pack years defined as \[(number of cigarettes smoked per day) x (number of years of smoking) / 20\], both current and ex-smokers are eligible.
. Use of bronchodilators in the previous 2 months to visit 1.
. Post-bronchodilator FEV1 \< 60% of the predicted normal value.
. Post-bronchodilator FEV1/FVC \< 0.7.
. A ≥ 5% response to a reversibility test.

A Study in Patients With Chronic Obstructive Pulmonary Disease

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

A Study in Patients With Chronic Obstructive Pulmonary Disease

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria