A Phase 4 interventional study of Roflumilast Oral Tablet and Azithromycin 250 mg in Chronic Obstructive Pulmonary Disease With Exacerbation, sponsored by Sidra Aziz. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Sidra Aziz · Phase 4, Interventional, and Prevention
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 32 studies testing roflumilast in Pulmonary Disease, Chronic Obstructive — 1 open to participants now, 1 under way, none of them phase 3. Roflumilast · Pulmonary Disease, Chronic Obstructive.
Among the 32 studies testing roflumilast in Pulmonary Disease, Chronic Obstructive, this one is the 21st largest by planned enrollment, is the only one that started in 2027, is one of 8 in phase 4, and was the 32nd registered.
5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →1 of the 32 studies testing roflumilast in Pulmonary Disease, Chronic Obstructive is open now.
Roflumilast: first FDA approval 2011 (DALIRESP), first EMA approval 2010. What it is approved for, and how studies give it, is on its page →
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: 40 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 17 · Phase 4 8
First in 2003; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 70 is above the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 154 across the 32 interventional studies. Of the 30 that completed or were terminated, 17 (57%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 32 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Sidra Aziz as lead sponsor.
Sidra Aziz has 1 study filed under Pulmonary Disease, Chronic Obstructive — fewer than ten, so there is no comparison to draw.
1 of the studies testing roflumilast in Pulmonary Disease, Chronic Obstructive that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07795086Sidra AzizComparative Effectiveness of Roflumilast and Azithromycin in Reducing Exacerbations in Severe Chronic Obstructive Pulmonary Disease ( COPD ) Patients With Chronic Bronchitis Phenotype | 2027-02 |
Add it to your calendar (.ics) → With an account.
Among the 32 studies testing roflumilast in Pulmonary Disease, Chronic Obstructive, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
"The study is a randomized controlled trial comparing roflumilast and azithromycin as add-on therapies in 70 patients with severe chronic obstructive pulmonary disease (COPD ) and frequent exacerbations. Participants will receive one of the two treatments for six months while continuing standard inhaled therapy. The study aims to determine which drug is more effective in reducing exacerbations and improving clinical outcomes such as forced expiratory volume in one second( FEV1) and modified medical research council ( mMRC)dyspnea scale , hospitalization, adherence, and safety, thereby providing evidence to guide chronic obstructive pulmonary disease management in our local population."
This single-center, randomized controlled trial (RCT) will compare roflumilast and azithromycin as add-on therapies in 70 participants with severe Chronic Obstructive Pulmonary Disease (COPD) and frequent exacerbations. Participants will receive either roflumilast 500 micrograms (µg) orally once daily or azithromycin 250 milligrams (mg) orally once daily for six months, in addition to standard inhaled chronic obstructive pulmonary disease(COPD) therapy. The study will evaluate the comparative effectiveness of these treatments in reducing the frequency and severity of chronic obstructive pulmonary disease (COPD) exacerbations and improving clinical outcomes, including forced expiratory volume in one second (FEV₁), modified Medical Research Council (mMRC) dyspnea score, hospitalization rates, treatment adherence, and safety. The findings are expected to provide local evidence to inform the selection of appropriate add-on therapy for patients with severe chronic obstructive pulmonary disease (COPD) and frequent exacerbations.
Protocol Description Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality worldwide and is characterized by persistent respiratory symptoms, progressive airflow limitation, and recurrent acute exacerbations. Frequent exacerbations are associated with accelerated decline in lung function, impaired quality of life, increased hospitalization rates, higher healthcare costs, and increased mortality. Despite optimal inhaled therapy, including long-acting bronchodilators with or without inhaled corticosteroids, many patients with severe chronic obstructive pulmonary disease (COPD) continue to experience recurrent exacerbations, underscoring the need for effective add-on therapies.
Roflumilast, an oral selective phosphodiesterase-4 (PDE-4) inhibitor, reduces airway inflammation by increasing intracellular cyclic adenosine monophosphate (cAMP) levels. It has been shown to reduce the frequency of exacerbations, particularly in participants with severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of frequent exacerbations. Azithromycin, a macrolide antibiotic, possesses anti-inflammatory and immunomodulatory properties in addition to its antimicrobial effects and has also demonstrated efficacy in reducing chronic obstructive pulmonary disease (COPD )exacerbations.
However, limited direct comparative evidence exists regarding the relative effectiveness and safety of roflumilast and azithromycin, particularly among patients with severe COPD in the Pakistani population. Accordingly, this study is designed to compare these two therapies as add-on treatments in patients who continue to experience frequent exacerbations despite standard inhaled therapy.
This single-center, randomized controlled trial will enroll 70 eligible patients with severe chronic obstructive pulmonary disease (COPD) and frequent exacerbations using non-probability consecutive sampling. Participants will be randomly assigned in a 1:1 ratio to two treatment groups. One group will receive roflumilast 500 micrograms (µg) orally once daily, while the other will receive azithromycin 250 milligrams (mg) orally once daily. Both treatments will be administered in addition to standard chronic obstructive pulmonary disease (COPD) therapy for six months.
At baseline, participants will undergo a comprehensive clinical assessment, including evaluation of demographic characteristics, smoking history, chronic obstructive pulmonary disease (COPD) history, exacerbation history, co morbidities, medication history, spirometry, and symptom burden using the modified Medical Research Council (mMRC) dyspnea scale. Post-bronchodilator forced expiratory volume in one second (FEV₁) and forced vital capacity (FVC) will be recorded in accordance with standard spirometric procedures.
Participants will be followed at scheduled intervals throughout the six-month treatment period. Follow-up assessments will include the occurrence and severity of COPD exacerbations, hospitalization, changes in post-bronchodilator FEV₁, mMRC dyspnea score, treatment adherence, and adverse drug events. Medication adherence will be assessed using study medication records and participant-reported follow-up information.
The primary outcome will be the reduction in the frequency and severity of chronic obstructive pulmonary disease (COPD) exacerbations during the six-month follow-up period.
Secondary outcomes will include:
The independent-samples t-test will be used to compare normally distributed continuous variables between the two treatment groups. The Mann-Whitney U test will be used for non-normally distributed continuous variables. The chi-square test or Fisher's exact test will be used to compare categorical variables, as appropriate. A p-value of ≤0.05 will be considered statistically significant.
Where appropriate, stratified analyses will be conducted to assess the potential influence of important baseline characteristics and confounding factors, including age, sex, smoking status, baseline forced expiratory volume in one second (FEV₁), baseline forced expiratory volume in one second/forced vital capacity (FEV₁/FVC) ratio, and comorbidities.
The study is expected to provide local evidence regarding the comparative effectiveness, tolerability, and safety of roflumilast and azithromycin as add-on therapies in participants with severe chronic obstructive pulmonary disease (COPD)and frequent exacerbations. The findings may assist clinicians in selecting an appropriate additional pharmacological treatment for participants who continue to experience exacerbations despite standard inhaled therapy.
The Results section will present findings obtained after completion of the six-month follow-up period. Baseline demographic and clinical characteristics will be compared between the roflumilast and azithromycin treatment groups to assess the comparability of the randomized groups.
The primary outcome will be reported as the frequency and severity of Chronic Obstructive Pulmonary Disease (COPD) exacerbations occurring during the six-month follow-up period. The number of exacerbations, the proportion of participants experiencing at least one exacerbation, and exacerbation severity will be compared between the two treatment groups.
Secondary outcomes will include changes in forced expiratory volume in one second (FEV₁), modified Medical Research Council (mMRC) dyspnea score, hospitalization rate, time to first chronic obstructive pulmonary disease (COPD) exacerbation, medication adherence, and adverse drug events.
Spirometric outcomes will be presented using post-bronchodilator forced expiratory volume in one second (FEV₁) and forced vital capacity (FVC). Changes from baseline to the end of the six-month treatment period will be compared between the two treatment groups.
Treatment adherence and adverse drug events will also be reported for both groups. Adverse events will be categorized according to type, frequency, severity, and whether they resulted in treatment discontinuation.
Statistical analysis will be performed using the Statistical Package for the Social Sciences (SPSS), version 27. Continuous variables will be presented as mean ± standard deviation (SD) or median with interquartile range (IQR), according to the distribution of the data. Categorical variables will be presented as frequencies and percentages. Appropriate statistical tests, including the independent-samples t-test, Mann-Whitney U test, chi-square test, and Fisher's exact test, will be applied according to the type and distribution of the data. A p-value of ≤0.05 will be considered statistically significant.
The final results will determine whether roflumilast or azithromycin provides greater benefit in reducing chronic obstructive pulmonary disease (COPD )exacerbations and improving clinical outcomes among patients with severe chronic obstructive pulmonary disease (COPD) and frequent exacerbations receiving standard inhaled therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A will receive oral roflumilast 500 microgram once daily
Drug: Roflumilast Oral Tablet
Group B will receive oral azithromycin 250 mg once daily
Drug: Azithromycin 250 mg
out of total 70 patients , 35 patients will receive roflumilast 500 microgram once daily
out of 70 patients 35 patients will receive azithromycin 250mg once daily
Number of moderate/severe chronic obstructive pulmonary disease (COPD) exacerbations over 6 months
Reduction in frequency of chronic obstructive pulmonary disease (COPD) exacerbations over 6 months, assessed by the number of moderate/severe exacerbations .
Time frame: 6 months
Proportion of participants requiring hospitalization for COPD exacerbation over 6 months
"Percentage of participants who experience a COPD exacerbation requiring hospital admission during the 6-month treatment period. Hospitalization will be considered COPD-related when the participant is admitted to hospital due to an acute worsening of COPD symptoms requiring inpatient management."
Time frame: 6 months
Changes in Lung Function
Changes in forced expiratory volume in one second to first COPD exacerbation over 6 months
Time frame: 6 months
Hospital admission rate
In this outcome measure frequency of hospital admission will be measured
Time frame: 6 months
Number of participants experiencing treatment-emergent adverse events
The number and proportion of participants experiencing adverse events related to study treatment during the six-month treatment period will be recorded and compared between the roflumilast and azithromycin groups.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
Start is estimated for Feb 2027; primary completion for Feb 2027, 0 months later.
Of 86 non-industry phase 4 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's planned 0 months is below that.
Counting every sponsor, half of 157 studies reached it within 19 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Roflumilast
Pulmonary Disease, Chronic Obstructive →